Osteoporosis
Conditions
Keywords
Osteoporosis, Postmenopause
Brief summary
The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.
Interventions
OTHERPlacebo
Placebo, daily, oral
BZA 20mg, daily, oral
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Must be at least 2 years postmenopausal * Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture
Exclusion criteria
* Diseases that may affect bone metabolism * Vasomotor symptoms requiring treatment * Known history or suspected cancer of the breast * Active or past history of venous thromboembolic events
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With New Vertebral Fractures Through Month 36 | Baseline through Month 36 | New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. |
| Percentage of Participants With New Vertebral Fractures Through Month 60 | Baseline through Month 60 | New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. |
| Percentage of Participants With New Vertebral Fractures Through Month 84 | Baseline through Month 84 | New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 | Baseline through Month 36 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. |
| Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 | Baseline through Month 60 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. |
| Percentage of Participants With New Clinical Vertebral Fractures Through Month 84 | Baseline through Month 84 | A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base. |
| Number of Participants With Worsening Vertebral Fractures Through Month 36 | Baseline through Month 36 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. |
| Number of Participants With Worsening Vertebral Fractures Through Month 60 | Baseline through Month 60 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. |
| Number of Participants With Worsening Vertebral Fractures Through Month 84 | Baseline through Month 84 | A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline. |
| Percentage of Participants With Non-vertebral Fractures Through Month 36 | Baseline through Month 36 | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. |
| Percentage of Participants With Non-vertebral Fractures Through Month 60 | Baseline through Month 60 | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. |
| Percentage of Participants With Non-vertebral Fractures Through Month 84 | Baseline through Month 84 | Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized. |
| Change From Baseline in Height at Month 36 | Baseline, Month 36 | Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). |
| Change From Baseline in Height at Month 60 | Baseline, Month 60 | Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). |
| Change From Baseline in Height at Month 84 | Baseline, Month 84 | Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded). |
| Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Baseline, Months 6, 12, 18, 24, 36 | BMD of lumbar spine (Lu Sp) and hip (total hip \[Tl Hp\], femoral neck \[Fe Ne\] and femur trochanter \[Fe Tr\]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. |
| Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Baseline, Month 48, 60 | BMD of lumbar spine (Lu Sp) and hip (total hip \[Tl Hp\], femoral neck \[Fe Ne\] and femur trochanter \[Fe Tr\]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. |
| Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Baseline, Month 72, 84 | BMD of lumbar spine (Lu Sp) and hip (total hip \[Tl Hp\], femoral neck \[Fe Ne\] and femur trochanter \[Fe Tr\]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher. |
| Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Baseline, Months 3, 6, 12 | Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels. |
| Percent Change From Baseline in Osteocalcin at Months 36 and 60 | Baseline, Months 36, 60 | Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels. |
| Percent Change From Baseline in Osteocalcin at Months 72 and 84 | Baseline, Months 72, 84 | Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels. |
| Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Baseline, Months 3, 6, 12 | C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels. |
| Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 | Baseline, Months 36, 60 | C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels. |
| Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84 | Baseline, Months 72, 84 | C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels. |
| Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | Baseline, Months 6, 12, 24, 36 | Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3). |
| Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | Month 36 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP). |
| Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | Month 60 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP). |
| Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | Month 36 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest. |
| Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | Month 60 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest. |
| Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG] | Month 36 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) \[TSG\]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm\^2 and expressed as percent (%) of the total surface. |
| Bone Histomorphometric Indices at Month 60: TSG | Month 60 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) \[TSG\]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm\^2 and expressed as percent (%) of the total surface. |
| Bone Histomorphometric Indices at Month 36: TtAr | Month 36 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made. |
| Bone Histomorphometric Indices at Month 60: TtAr | Month 60 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made. |
| Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | Month 36 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP). |
| Bone Histomorphometric Indices at Month 60: BFP, RP and RmP | Month 60 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP). |
| Bone Histomorphometric Indices at Month 36: SuD | Month 36 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD). |
| Bone Histomorphometric Indices at Month 60: SuD | Month 60 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD). |
| Bone Histomorphometric Indices at Month 36: BFRTS | Month 36 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR). |
| Bone Histomorphometric Indices at Month 60: BFRTS | Month 60 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR). |
| Bone Histomorphometric Indices at Month 36: ACF | Month 36 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF). |
| Bone Histomorphometric Indices at Month 60: ACF | Month 60 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF). |
| Bone Histomorphometric Indices at Month 36: Mlt | Month 36 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added. |
| Bone Histomorphometric Indices at Month 60: Mlt | Month 60 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added. |
| Bone Histomorphometric Indices at Month 36: MAR | Month 36 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval. |
| Bone Histomorphometric Indices at Month 60: MAR | Month 60 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval. |
| Bone Histomorphometric Indices at Month 36: TbN | Month 36 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness. |
| Bone Histomorphometric Indices at Month 60: TbN | Month 60 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness. |
| Bone Histomorphometric Indices at Month 36: BFRBV | Month 36 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR). |
| Bone Histomorphometric Indices at Month 60: BFRBV | Month 60 | Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR). |
| Women's Health Questionnaire (WHQ) | Baseline | WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Baseline, Months 12, 24, 36 | WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline | QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Incidence of Breast Cancer Through Month 36 | Baseline through Month 36 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). |
| Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Baseline, Months 12, 24, 36 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Baseline, Months 12, 24, 36 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Baseline, Months 12, 24, 36 | QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points. |
| Incidence of Breast Cancer Through Month 60 | Baseline through Month 60 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). |
| Incidence of Breast Cancer Through Month 84 | Baseline through Month 84 | Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time). |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Russia, Slovakia, South Africa, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bazedoxifene 20 mg (Core+SE I) Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit \[IU\]) orally twice daily. | 1,886 |
| Bazedoxifene 40 mg (Core) Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | 1,872 |
| Raloxifene 60 mg (Core) Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | 1,849 |
| Placebo (Core+SE I+SE II) Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | 1,885 |
| Total | 7,492 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Completed Core Study, Entered SE I | Other Event | 52 | 46 | 47 | 50 | 0 | 0 |
| Completed Core Study, Entered SE I | Withdrawal by Subject | 180 | 158 | 160 | 174 | 0 | 0 |
| Completed SE I, Entered Extension SE II | No-consent/eligible/SEII continuing site | 273 | 0 | 0 | 240 | 258 | 0 |
| Core Study (Up to 3 Years) | Adverse Event | 260 | 267 | 252 | 232 | 0 | 0 |
| Core Study (Up to 3 Years) | Death | 9 | 7 | 14 | 7 | 0 | 0 |
| Core Study (Up to 3 Years) | Failed to return | 40 | 25 | 27 | 27 | 0 | 0 |
| Core Study (Up to 3 Years) | Lack of Efficacy | 52 | 52 | 39 | 75 | 0 | 0 |
| Core Study (Up to 3 Years) | Other Event | 49 | 52 | 41 | 58 | 0 | 0 |
| Core Study (Up to 3 Years) | Protocol Violation | 53 | 55 | 50 | 42 | 0 | 0 |
| Core Study (Up to 3 Years) | Randomized but not treated | 21 | 32 | 35 | 29 | 0 | 0 |
| Core Study (Up to 3 Years) | Withdrawal by Subject | 144 | 169 | 149 | 162 | 0 | 0 |
| Study Extension I | Adverse Event | 57 | 0 | 0 | 61 | 58 | 0 |
| Study Extension I | Death | 5 | 0 | 0 | 1 | 2 | 0 |
| Study Extension I | Failed to return | 15 | 0 | 0 | 17 | 13 | 0 |
| Study Extension I | Lack of Efficacy | 0 | 0 | 0 | 1 | 2 | 0 |
| Study Extension I | Other Event | 34 | 0 | 0 | 34 | 29 | 0 |
| Study Extension I | Protocol Violation | 4 | 0 | 0 | 8 | 8 | 0 |
| Study Extension I | Withdrawal by Subject | 99 | 0 | 0 | 106 | 89 | 0 |
| Study Extension I | Withdrawn as per protocol | 0 | 0 | 1,070 | 0 | 0 | 0 |
| Study Extension II | Adverse Event | 0 | 0 | 0 | 14 | 0 | 30 |
| Study Extension II | Death | 0 | 0 | 0 | 2 | 0 | 5 |
| Study Extension II | Enrolled but not treated | 0 | 0 | 0 | 71 | 0 | 131 |
| Study Extension II | Failed to return | 0 | 0 | 0 | 14 | 0 | 26 |
| Study Extension II | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 1 |
| Study Extension II | Other Event | 0 | 0 | 0 | 12 | 0 | 20 |
| Study Extension II | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 10 |
| Study Extension II | Withdrawal by Subject | 0 | 0 | 0 | 35 | 0 | 59 |
Baseline characteristics
| Characteristic | Bazedoxifene 20 mg (Core+SE I) | Bazedoxifene 40 mg (Core) | Raloxifene 60 mg (Core) | Placebo (Core+SE I+SE II) | Total |
|---|---|---|---|---|---|
| Age Continuous | 66.48 years STANDARD_DEVIATION 6.53 | 66.22 years STANDARD_DEVIATION 6.8 | 66.36 years STANDARD_DEVIATION 6.74 | 66.47 years STANDARD_DEVIATION 6.76 | 66.38 years STANDARD_DEVIATION 6.71 |
| Height | 156.60 centimeter (cm) STANDARD_DEVIATION 7.21 | 156.28 centimeter (cm) STANDARD_DEVIATION 7.38 | 156.37 centimeter (cm) STANDARD_DEVIATION 7.23 | 156.35 centimeter (cm) STANDARD_DEVIATION 6.9 | 156.40 centimeter (cm) STANDARD_DEVIATION 7.18 |
| Sex: Female, Male Female | 1886 Participants | 1872 Participants | 1849 Participants | 1885 Participants | 7492 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1,818 / 1,886 | 1,800 / 1,872 | 1,775 / 1,849 | 1,823 / 1,885 |
| serious Total, serious adverse events | 507 / 1,886 | 468 / 1,872 | 393 / 1,849 | 479 / 1,885 |
Outcome results
Primary
Percentage of Participants With New Vertebral Fractures Through Month 36
New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
Time frame: Baseline through Month 36
Population: Intent-to-treat(ITT) population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With New Vertebral Fractures Through Month 36 | No Prevalent Fracture (n=757,744,742,760) | 1.98 Percentage of participants |
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With New Vertebral Fractures Through Month 36 | At Least 1 Prevalent Fracture (n=967,942,954,981) | 2.63 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With New Vertebral Fractures Through Month 36 | At Least 1 Prevalent Fracture (n=967,942,954,981) | 2.80 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With New Vertebral Fractures Through Month 36 | No Prevalent Fracture (n=757,744,742,760) | 2.14 Percentage of participants |
| Raloxifene 60 mg (Core) | Percentage of Participants With New Vertebral Fractures Through Month 36 | No Prevalent Fracture (n=757,744,742,760) | 1.84 Percentage of participants |
| Raloxifene 60 mg (Core) | Percentage of Participants With New Vertebral Fractures Through Month 36 | At Least 1 Prevalent Fracture (n=967,942,954,981) | 2.74 Percentage of participants |
| Placebo (Core+SE I+SE II) | Percentage of Participants With New Vertebral Fractures Through Month 36 | No Prevalent Fracture (n=757,744,742,760) | 3.13 Percentage of participants |
| Placebo (Core+SE I+SE II) | Percentage of Participants With New Vertebral Fractures Through Month 36 | At Least 1 Prevalent Fracture (n=967,942,954,981) | 4.80 Percentage of participants |
Comparison: No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% confidence intervals (CIs).p-value: 0.2295% CI: [0.322, 1.302]Log Rank
Comparison: No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.2495% CI: [0.322, 1.301]Log Rank
Comparison: No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.8395% CI: [0.501, 2.405]Log Rank
Comparison: No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.8795% CI: [0.49, 2.356]Log Rank
Comparison: No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.9695% CI: [0.458, 2.131]Log Rank
Comparison: No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.1695% CI: [0.289, 1.212]Log Rank
Comparison: At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.03595% CI: [0.324, 0.937]Log Rank
Comparison: At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.0795% CI: [0.373, 1.045]Log Rank
Comparison: At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.7995% CI: [0.605, 1.947]Log Rank
Comparison: At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.9995% CI: [0.527, 1.743]Log Rank
Comparison: At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.7895% CI: [0.488, 1.593]Log Rank
Comparison: At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.03695% CI: [0.34, 0.968]Log Rank
Primary
Percentage of Participants With New Vertebral Fractures Through Month 60
New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
Time frame: Baseline through Month 60
Population: ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With New Vertebral Fractures Through Month 60 | No Prevalent Fracture (n=757,760,744) | 3.11 Percentage of participants |
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With New Vertebral Fractures Through Month 60 | At Least 1 Prevalent Fracture (n=967,981,942) | 5.67 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With New Vertebral Fractures Through Month 60 | No Prevalent Fracture (n=757,760,744) | 5.40 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With New Vertebral Fractures Through Month 60 | At Least 1 Prevalent Fracture (n=967,981,942) | 7.95 Percentage of participants |
| Raloxifene 60 mg (Core) | Percentage of Participants With New Vertebral Fractures Through Month 60 | No Prevalent Fracture (n=757,760,744) | 3.46 Percentage of participants |
| Raloxifene 60 mg (Core) | Percentage of Participants With New Vertebral Fractures Through Month 60 | At Least 1 Prevalent Fracture (n=967,981,942) | 4.28 Percentage of participants |
Comparison: No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.09795% CI: [0.339, 1.099]Log Rank
Comparison: No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.1595% CI: [0.361, 1.151]Log Rank
Comparison: No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.8395% CI: [0.493, 1.793]Log Rank
Comparison: At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.06795% CI: [0.435, 1.019]Log Rank
Comparison: At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.01495% CI: [0.367, 0.896]Log Rank
Comparison: At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.595% CI: [0.71, 1.885]Log Rank
Primary
Percentage of Participants With New Vertebral Fractures Through Month 84
New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
Time frame: Baseline through Month 84
Population: Modified ITT(mITT) population of safety population category one(SP1) population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With New Vertebral Fractures Through Month 84 | No Prevalent Fracture (n=760,1501) | 8.18 Percentage of participants |
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With New Vertebral Fractures Through Month 84 | At Least 1 Prevalent Fracture (n=981,1909) | 11.35 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With New Vertebral Fractures Through Month 84 | No Prevalent Fracture (n=760,1501) | 5.79 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With New Vertebral Fractures Through Month 84 | At Least 1 Prevalent Fracture (n=981,1909) | 6.90 Percentage of participants |
Comparison: No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.08595% CI: [0.44, 1.052]Log Rank
Comparison: At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.00495% CI: [0.434, 0.857]Log Rank
Secondary
Bone Histomorphometric Indices at Month 36: ACF
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).
Time frame: Month 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: ACF | 0.421 Activation of bone formation/year | Standard Error 0.058 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: ACF | 0.385 Activation of bone formation/year | Standard Error 0.054 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: ACF | 0.290 Activation of bone formation/year | Standard Error 0.058 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: ACF | 0.410 Activation of bone formation/year | Standard Error 0.054 |
p-value: 0.9ANOVA
p-value: 0.74ANOVA
p-value: 0.13ANOVA
p-value: 0.11ANOVA
p-value: 0.24ANOVA
Secondary
Bone Histomorphometric Indices at Month 36: BFP, RP and RmP
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).
Time frame: Month 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | BFP (n=24,27,24,27) | 0.463 years (yrs) | Standard Error 0.08 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | RmP (n=24,27,24,27) | 0.543 years (yrs) | Standard Error 0.095 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | RP (n=24,27,24,27) | 0.080 years (yrs) | Standard Error 0.029 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | BFP (n=24,27,24,27) | 0.441 years (yrs) | Standard Error 0.076 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | RmP (n=24,27,24,27) | 0.508 years (yrs) | Standard Error 0.09 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | RP (n=24,27,24,27) | 0.066 years (yrs) | Standard Error 0.027 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | RP (n=24,27,24,27) | 0.125 years (yrs) | Standard Error 0.029 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | BFP (n=24,27,24,27) | 0.751 years (yrs) | Standard Error 0.08 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | RmP (n=24,27,24,27) | 0.876 years (yrs) | Standard Error 0.095 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | BFP (n=24,27,24,27) | 0.436 years (yrs) | Standard Error 0.076 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | RmP (n=24,27,24,27) | 0.531 years (yrs) | Standard Error 0.09 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BFP, RP and RmP | RP (n=24,27,24,27) | 0.096 years (yrs) | Standard Error 0.027 |
Comparison: BFP: P value was calculated using ANOVA.p-value: 0.81ANOVA
Comparison: BFP: P value was calculated using ANOVA.p-value: 0.96ANOVA
Comparison: BFP: P value was calculated using ANOVA.p-value: 0.005ANOVA
Comparison: BFP: P value was calculated using ANOVA.p-value: 0.013ANOVA
Comparison: BFP: P value was calculated using ANOVA.p-value: 0.006ANOVA
Comparison: RP: P value was calculated using ANOVA.p-value: 0.7ANOVA
Comparison: RP: P value was calculated using ANOVA.p-value: 0.44ANOVA
Comparison: RP: P value was calculated using ANOVA.p-value: 0.47ANOVA
Comparison: RP: P value was calculated using ANOVA.p-value: 0.28ANOVA
Comparison: RP: P value was calculated using ANOVA.p-value: 0.14ANOVA
Comparison: RmP: P value was calculated using ANOVA.p-value: 0.93ANOVA
Comparison: RmP: P value was calculated using ANOVA.p-value: 0.85ANOVA
Comparison: RmP: P value was calculated using ANOVA.p-value: 0.01ANOVA
Comparison: RmP: P value was calculated using ANOVA.p-value: 0.015ANOVA
Comparison: RmP: P value was calculated using ANOVA.p-value: 0.006ANOVA
Secondary
Bone Histomorphometric Indices at Month 36: BFRBV
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).
Time frame: Month 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BFRBV | 0.186 square millimetre/square millimetre/year | Standard Error 0.024 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BFRBV | 0.171 square millimetre/square millimetre/year | Standard Error 0.022 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BFRBV | 0.122 square millimetre/square millimetre/year | Standard Error 0.024 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BFRBV | 0.187 square millimetre/square millimetre/year | Standard Error 0.022 |
p-value: 0.61ANOVA
p-value: 0.97ANOVA
p-value: 0.05ANOVA
p-value: 0.061ANOVA
p-value: 0.14ANOVA
Secondary
Bone Histomorphometric Indices at Month 36: BFRTS
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).
Time frame: Month 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BFRTS | 0.013 cubic millimetre/square millimetre/year | Standard Error 0.002 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BFRTS | 0.012 cubic millimetre/square millimetre/year | Standard Error 0.002 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BFRTS | 0.009 cubic millimetre/square millimetre/year | Standard Error 0.002 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BFRTS | 0.012 cubic millimetre/square millimetre/year | Standard Error 0.002 |
p-value: 0.68ANOVA
p-value: 0.97ANOVA
p-value: 0.18ANOVA
p-value: 0.088ANOVA
p-value: 0.17ANOVA
Secondary
Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).
Time frame: Month 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ES (n=25,27,28,30) | 1.610 Percentage of indices | Standard Error 0.196 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | MS (n=25,27,28,30) | 5.962 Percentage of indices | Standard Error 0.852 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | CP (n=25,27,27,29) | 4.484 Percentage of indices | Standard Error 0.397 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OcS (n=25,27,28,30) | 0.276 Percentage of indices | Standard Error 0.045 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OS (n=25,27,28,30) | 12.516 Percentage of indices | Standard Error 1.795 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OV (n=25,27,28,30) | 1.513 Percentage of indices | Standard Error 0.244 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OMS (n=28,29,32,32) | 49.629 Percentage of indices | Standard Error 5.442 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ObS (n=25,27,28,30) | 4.235 Percentage of indices | Standard Error 0.623 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | BV (n=25,27,28,30) | 17.078 Percentage of indices | Standard Error 1.14 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ObS (n=25,27,28,30) | 4.225 Percentage of indices | Standard Error 0.6 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ES (n=25,27,28,30) | 1.855 Percentage of indices | Standard Error 0.189 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | MS (n=25,27,28,30) | 5.960 Percentage of indices | Standard Error 0.82 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OV (n=25,27,28,30) | 1.644 Percentage of indices | Standard Error 0.234 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | BV (n=25,27,28,30) | 19.155 Percentage of indices | Standard Error 1.097 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OS (n=25,27,28,30) | 14.196 Percentage of indices | Standard Error 1.728 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | CP (n=25,27,27,29) | 4.130 Percentage of indices | Standard Error 0.382 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OMS (n=28,29,32,32) | 49.145 Percentage of indices | Standard Error 5.347 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OcS (n=25,27,28,30) | 0.334 Percentage of indices | Standard Error 0.043 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ObS (n=25,27,28,30) | 2.772 Percentage of indices | Standard Error 0.589 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | BV (n=25,27,28,30) | 16.650 Percentage of indices | Standard Error 1.077 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OV (n=25,27,28,30) | 1.290 Percentage of indices | Standard Error 0.23 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OS (n=25,27,28,30) | 12.442 Percentage of indices | Standard Error 1.697 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OcS (n=25,27,28,30) | 0.215 Percentage of indices | Standard Error 0.043 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | MS (n=25,27,28,30) | 3.926 Percentage of indices | Standard Error 0.805 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ES (n=25,27,28,30) | 1.891 Percentage of indices | Standard Error 0.185 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OMS (n=28,29,32,32) | 37.856 Percentage of indices | Standard Error 5.091 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | CP (n=25,27,27,29) | 4.319 Percentage of indices | Standard Error 0.382 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ES (n=25,27,28,30) | 1.299 Percentage of indices | Standard Error 0.179 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OcS (n=25,27,28,30) | 0.242 Percentage of indices | Standard Error 0.041 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OS (n=25,27,28,30) | 12.934 Percentage of indices | Standard Error 1.639 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | CP (n=25,27,27,29) | 4.334 Percentage of indices | Standard Error 0.369 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OMS (n=28,29,32,32) | 51.503 Percentage of indices | Standard Error 5.091 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OV (n=25,27,28,30) | 1.605 Percentage of indices | Standard Error 0.222 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | MS (n=25,27,28,30) | 5.705 Percentage of indices | Standard Error 0.778 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ObS (n=25,27,28,30) | 3.672 Percentage of indices | Standard Error 0.569 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | BV (n=25,27,28,30) | 17.144 Percentage of indices | Standard Error 1.041 |
Comparison: BV: P value was calculated using Analysis of Variance (ANOVA).p-value: 0.97ANOVA
Comparison: BV: P value was calculated using ANOVA.p-value: 0.19ANOVA
Comparison: BV: P value was calculated using ANOVA.p-value: 0.74ANOVA
Comparison: BV: P value was calculated using ANOVA.p-value: 0.79ANOVA
Comparison: BV: P value was calculated using ANOVA.p-value: 0.11ANOVA
Comparison: OV: P value was calculated using ANOVA.p-value: 0.78ANOVA
Comparison: OV: P value was calculated using ANOVA.p-value: 0.9ANOVA
Comparison: OV: P value was calculated using ANOVA.p-value: 0.33ANOVA
Comparison: OV: P value was calculated using ANOVA.p-value: 0.51ANOVA
Comparison: OV: P value was calculated using ANOVA.p-value: 0.28ANOVA
Comparison: OS: P value was calculated using ANOVA.p-value: 0.86ANOVA
Comparison: OS: P value was calculated using ANOVA.p-value: 0.6ANOVA
Comparison: OS: P value was calculated using ANOVA.p-value: 0.84ANOVA
Comparison: OS: P value was calculated using ANOVA.p-value: 0.98ANOVA
Comparison: OS: P value was calculated using ANOVA.p-value: 0.47ANOVA
Comparison: OcS: P value was calculated using ANOVA.p-value: 0.59ANOVA
Comparison: OcS: P value was calculated using ANOVA.p-value: 0.13ANOVA
Comparison: OcS: P value was calculated using ANOVA.p-value: 0.65ANOVA
Comparison: OcS: P value was calculated using ANOVA.p-value: 0.33ANOVA
Comparison: OcS: P value was calculated using ANOVA.p-value: 0.053ANOVA
Comparison: ObS: P value was calculated using ANOVA.p-value: 0.51ANOVA
Comparison: ObS: P value was calculated using ANOVA.p-value: 0.5ANOVA
Comparison: ObS: P value was calculated using ANOVA.p-value: 0.27ANOVA
Comparison: ObS: P value was calculated using ANOVA.p-value: 0.091ANOVA
Comparison: ObS: P value was calculated using ANOVA.p-value: 0.087ANOVA
Comparison: MS: P value was calculated using ANOVA.p-value: 0.82ANOVA
Comparison: MS: P value was calculated using ANOVA.p-value: 0.82ANOVA
Comparison: MS: P value was calculated using ANOVA.p-value: 0.12ANOVA
Comparison: MS: P value was calculated using ANOVA.p-value: 0.085ANOVA
Comparison: MS: P value was calculated using ANOVA.p-value: 0.08ANOVA
Comparison: ES: P value was calculated using ANOVA.p-value: 0.24ANOVA
Comparison: ES: P value was calculated using ANOVA.p-value: 0.035ANOVA
Comparison: ES: P value was calculated using ANOVA.p-value: 0.024ANOVA
Comparison: ES: P value was calculated using ANOVA.p-value: 0.3ANOVA
Comparison: ES: P value was calculated using ANOVA.p-value: 0.89ANOVA
Comparison: OMS: P value was calculated using ANOVA.p-value: 0.8ANOVA
Comparison: OMS: P value was calculated using ANOVA.p-value: 0.75ANOVA
Comparison: OMS: P value was calculated using ANOVA.p-value: 0.06ANOVA
Comparison: OMS: P value was calculated using ANOVA.p-value: 0.12ANOVA
Comparison: OMS: P value was calculated using ANOVA.p-value: 0.13ANOVA
Comparison: CP: P value was calculated using ANOVA.p-value: 0.78ANOVA
Comparison: CP: P value was calculated using ANOVA.p-value: 0.7ANOVA
Comparison: CP: P value was calculated using ANOVA.p-value: 0.98ANOVA
Comparison: CP: P value was calculated using ANOVA.p-value: 0.76ANOVA
Comparison: CP: P value was calculated using ANOVA.p-value: 0.73ANOVA
Secondary
Bone Histomorphometric Indices at Month 36: MAR
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.
Time frame: Month 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: MAR | 0.578 mcm/days (mcm/d) | Standard Error 0.02 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: MAR | 0.563 mcm/days (mcm/d) | Standard Error 0.019 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: MAR | 0.520 mcm/days (mcm/d) | Standard Error 0.02 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: MAR | 0.550 mcm/days (mcm/d) | Standard Error 0.019 |
p-value: 0.3ANOVA
p-value: 0.62ANOVA
p-value: 0.28ANOVA
p-value: 0.041ANOVA
p-value: 0.12ANOVA
Secondary
Bone Histomorphometric Indices at Month 36: Mlt
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.
Time frame: Month 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: Mlt | 31.650 days | Standard Error 5.141 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: Mlt | 30.337 days | Standard Error 4.847 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: Mlt | 48.383 days | Standard Error 5.141 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: Mlt | 29.533 days | Standard Error 4.847 |
p-value: 0.77ANOVA
p-value: 0.91ANOVA
p-value: 0.009ANOVA
p-value: 0.023ANOVA
p-value: 0.012ANOVA
Secondary
Bone Histomorphometric Indices at Month 36: SuD
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).
Time frame: Month 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: SuD | 2.405 square millimeter per cubic millimeter | Standard Error 0.109 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: SuD | 2.632 square millimeter per cubic millimeter | Standard Error 0.105 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: SuD | 2.424 square millimeter per cubic millimeter | Standard Error 0.103 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: SuD | 2.587 square millimeter per cubic millimeter | Standard Error 0.1 |
p-value: 0.22ANOVA
p-value: 0.76ANOVA
p-value: 0.26ANOVA
p-value: 0.9ANOVA
p-value: 0.16ANOVA
Secondary
Bone Histomorphometric Indices at Month 36: TbN
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.
Time frame: Month 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: TbN | 1.202 ratio/millimeter (ratio/mm) | Standard Error 0.055 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: TbN | 1.315 ratio/millimeter (ratio/mm) | Standard Error 0.053 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: TbN | 1.212 ratio/millimeter (ratio/mm) | Standard Error 0.052 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: TbN | 1.293 ratio/millimeter (ratio/mm) | Standard Error 0.05 |
p-value: 0.22ANOVA
p-value: 0.76ANOVA
p-value: 0.26ANOVA
p-value: 0.89ANOVA
p-value: 0.17ANOVA
Secondary
Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG]
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) \[TSG\]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm\^2 and expressed as percent (%) of the total surface.
Time frame: Month 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG] | 95.111 millimeter (mm) | Standard Error 8.429 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG] | 110.897 millimeter (mm) | Standard Error 8.283 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG] | 94.353 millimeter (mm) | Standard Error 7.885 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: Total Surface (Goldner Slide) [TSG] | 105.912 millimeter (mm) | Standard Error 7.885 |
p-value: 0.35ANOVA
p-value: 0.66ANOVA
p-value: 0.3ANOVA
p-value: 0.95ANOVA
p-value: 0.15ANOVA
Secondary
Bone Histomorphometric Indices at Month 36: TtAr
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.
Time frame: Month 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: TtAr | 39.904 Square millimeter (mm^2) | Standard Error 3.066 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: TtAr | 42.334 Square millimeter (mm^2) | Standard Error 3.013 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: TtAr | 39.497 Square millimeter (mm^2) | Standard Error 2.868 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: TtAr | 41.459 Square millimeter (mm^2) | Standard Error 2.868 |
p-value: 0.71ANOVA
p-value: 0.83ANOVA
p-value: 0.63ANOVA
p-value: 0.92ANOVA
p-value: 0.5ANOVA
Secondary
Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Wall Thickness (WTh), Osteoid Thickness (OTh), Trabecular Thickness (TbTh), Trabecular Separation (TbSp) and Cortical thickness (CTh). Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.
Time frame: Month 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | TbSp (n=25,27,28,30) | 865.040 micrometer (mcm) | Standard Error 42.634 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | OTh (n=25,27,28,30) | 6.180 micrometer (mcm) | Standard Error 0.221 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | CTh (n=25,27,27,30) | 891.480 micrometer (mcm) | Standard Error 68.949 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | TbTh (n=25,27,28,30) | 140.440 micrometer (mcm) | Standard Error 7.128 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | WTh (n=25,27,28,30) | 31.348 micrometer (mcm) | Standard Error 0.541 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | TbTh (n=25,27,28,30) | 146.296 micrometer (mcm) | Standard Error 6.859 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | TbSp (n=25,27,28,30) | 770.148 micrometer (mcm) | Standard Error 41.024 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | CTh (n=25,27,27,30) | 694.370 micrometer (mcm) | Standard Error 66.346 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | OTh (n=25,27,28,30) | 6.085 micrometer (mcm) | Standard Error 0.212 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | WTh (n=25,27,28,30) | 31.689 micrometer (mcm) | Standard Error 0.521 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | TbTh (n=25,27,28,30) | 139.143 micrometer (mcm) | Standard Error 6.735 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | WTh (n=25,27,28,30) | 31.089 micrometer (mcm) | Standard Error 0.512 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | OTh (n=25,27,28,30) | 5.554 micrometer (mcm) | Standard Error 0.209 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | TbSp (n=25,27,28,30) | 880.571 micrometer (mcm) | Standard Error 40.285 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | CTh (n=25,27,27,30) | 781.593 micrometer (mcm) | Standard Error 66.346 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | TbSp (n=25,27,28,30) | 787.900 micrometer (mcm) | Standard Error 38.919 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | OTh (n=25,27,28,30) | 5.660 micrometer (mcm) | Standard Error 0.202 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | WTh (n=25,27,28,30) | 30.447 micrometer (mcm) | Standard Error 0.494 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | TbTh (n=25,27,28,30) | 131.333 micrometer (mcm) | Standard Error 6.507 |
| Placebo (Core+SE I+SE II) | Bone Histomorphometric Indices at Month 36: WTh, OTh, TbTh, TbSp and CTh | CTh (n=25,27,27,30) | 761.467 micrometer (mcm) | Standard Error 62.941 |
Comparison: WTh: P value was calculated using ANOVA.p-value: 0.22ANOVA
Comparison: WTh: p-value was calculated using ANOVA.p-value: 0.087ANOVA
Comparison: WTh: p-value was calculated using ANOVA.p-value: 0.37ANOVA
Comparison: WTh: p-value was calculated using ANOVA.p-value: 0.73ANOVA
Comparison: WTh: p-value was calculated using ANOVA.p-value: 0.41ANOVA
Comparison: OTh: P value was calculated using ANOVA.p-value: 0.085ANOVA
Comparison: OTh: P value was calculated using ANOVA.p-value: 0.15ANOVA
Comparison: OTh: P value was calculated using ANOVA.p-value: 0.71ANOVA
Comparison: OTh: P value was calculated using ANOVA.p-value: 0.042ANOVA
Comparison: OTh: P value was calculated using ANOVA.p-value: 0.077ANOVA
Comparison: TbTh: P value was calculated using ANOVA.p-value: 0.35ANOVA
Comparison: TbTh: P value was calculated using ANOVA.p-value: 0.12ANOVA
Comparison: TbTh: P value was calculated using ANOVA.p-value: 0.41ANOVA
Comparison: TbTh: P value was calculated using ANOVA.p-value: 0.9ANOVA
Comparison: TbTh: P value was calculated using ANOVA.p-value: 0.46ANOVA
Comparison: TbSp: P value was calculated using ANOVA.p-value: 0.18ANOVA
Comparison: TbSp: P value was calculated using ANOVA.p-value: 0.75ANOVA
Comparison: TbSp: P value was calculated using ANOVA.p-value: 0.1ANOVA
Comparison: TbSp: P value was calculated using ANOVA.p-value: 0.79ANOVA
Comparison: TbSp: P value was calculated using ANOVA.p-value: 0.057ANOVA
Comparison: CTh: P value was calculated using ANOVA.p-value: 0.17ANOVA
Comparison: CTh: P value was calculated using ANOVA.p-value: 0.46ANOVA
Comparison: CTh: P value was calculated using ANOVA.p-value: 0.83ANOVA
Comparison: CTh: P value was calculated using ANOVA.p-value: 0.25ANOVA
Comparison: CTh: P value was calculated using ANOVA.p-value: 0.35ANOVA
Secondary
Bone Histomorphometric Indices at Month 60: ACF
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Activation Frequency (ACF). The total period (TP) is the duration between the beginning of one formation period (FP) and the beginning of the next FP. The number of times per year that this spot begins the FP is the activation frequency (ACF).
Time frame: Month 60
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: ACF | 0.375 Activation of bone formation/year | Standard Error 0.106 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: ACF | 0.198 Activation of bone formation/year | Standard Error 0.075 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: ACF | 0.610 Activation of bone formation/year | Standard Error 0.151 |
p-value: 0.25ANOVA
p-value: 0.07ANOVA
Secondary
Bone Histomorphometric Indices at Month 60: BFP, RP and RmP
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Bone Formation Period (BFP), Resorption Period (RP), Remodeling Period (RmP).
Time frame: Month 60
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BFP, RP and RmP | RP (n=2,4,1) | 0.035 yrs | Standard Error 0.011 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BFP, RP and RmP | BFP (n=2,4,1) | 0.545 yrs | Standard Error 0.391 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BFP, RP and RmP | RmP (n=2,4,1) | 0.580 yrs | Standard Error 0.403 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BFP, RP and RmP | RP (n=2,4,1) | 0.035 yrs | Standard Error 0.008 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BFP, RP and RmP | BFP (n=2,4,1) | 0.820 yrs | Standard Error 0.277 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BFP, RP and RmP | RmP (n=2,4,1) | 0.860 yrs | Standard Error 0.285 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BFP, RP and RmP | BFP (n=2,4,1) | 0.390 yrs | Standard Error 0.553 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BFP, RP and RmP | RmP (n=2,4,1) | 0.410 yrs | Standard Error 0.569 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BFP, RP and RmP | RP (n=2,4,1) | 0.020 yrs | Standard Error 0.015 |
Comparison: RmP: P value was calculated using ANOVA.p-value: 0.52ANOVA
Comparison: BFP: P value was calculated using ANOVA.p-value: 0.6ANOVA
Comparison: BFP: P value was calculated using ANOVA.p-value: 0.53ANOVA
Comparison: RP: P value was calculated using ANOVA.p-value: 1ANOVA
Comparison: RP: P value was calculated using ANOVA.p-value: 0.43ANOVA
Comparison: RmP: P value was calculated using ANOVA.p-value: 0.6ANOVA
Secondary
Bone Histomorphometric Indices at Month 60: BFRBV
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Formation Rate (BFR)-Bone Volume Reference (BFRBV). BFR accounts the bone volume which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing volume and bone volume multiplied by mineralization apposition rate (MAR).
Time frame: Month 60
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BFRBV | 0.167 square millimetre/square millimetre/year | Standard Error 0.042 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BFRBV | 0.075 square millimetre/square millimetre/year | Standard Error 0.03 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BFRBV | 0.253 square millimetre/square millimetre/year | Standard Error 0.059 |
p-value: 0.15ANOVA
p-value: 0.056ANOVA
Secondary
Bone Histomorphometric Indices at Month 60: BFRTS
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Bone Form Rate (BFR)-Total Surface Reference (BFRTS). BFR accounts the bone surface which is actively mineralizing, which depends on the number of osteoblasts that are active. BFR= Fraction of mineralizing surface and bone surface multiplied by mineralization apposition rate (MAR).
Time frame: Month 60
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BFRTS | 0.013 cubic millimetre/square millimetre/year | Standard Error 0.003 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BFRTS | 0.006 cubic millimetre/square millimetre/year | Standard Error 0.002 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BFRTS | 0.018 cubic millimetre/square millimetre/year | Standard Error 0.005 |
p-value: 0.25ANOVA
p-value: 0.1ANOVA
Secondary
Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Percentage of following indices (volume,surface,porosity) was calculated:Bone Volume(BV), Osteoid Volume(OV), Osteoid Surface(OS), Osteoclast Surface(OcS), Osteoblast Surface(ObS), Mineralizing surface(MS), Eroded Surface(ES), Osteoid Mineralizing surface(OMS), Cortical porosity(CP).
Time frame: Month 60
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OMS (n=3,5,1) | 57.300 Percentage of indices | Standard Error 21.483 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ObS (n=2,4,1) | 7.170 Percentage of indices | Standard Error 2.1 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OS (n=2,4,1) | 20.270 Percentage of indices | Standard Error 3.091 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ES (n=2,4,1) | 1.225 Percentage of indices | Standard Error 0.226 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | MS (n=2,4,1) | 6.910 Percentage of indices | Standard Error 1.614 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OV (n=2,4,1) | 2.550 Percentage of indices | Standard Error 0.258 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | CP (n=0,0,0) | NA Percentage of indices | — |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OcS (n=2,4,1) | 0.445 Percentage of indices | Standard Error 0.137 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | BV (n=2,4,1) | 20.315 Percentage of indices | Standard Error 4.882 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | BV (n=2,4,1) | 17.818 Percentage of indices | Standard Error 3.452 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OV (n=2,4,1) | 0.893 Percentage of indices | Standard Error 0.183 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OS (n=2,4,1) | 9.772 Percentage of indices | Standard Error 2.186 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OcS (n=2,4,1) | 0.173 Percentage of indices | Standard Error 0.097 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ObS (n=2,4,1) | 2.430 Percentage of indices | Standard Error 1.485 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | MS (n=2,4,1) | 2.920 Percentage of indices | Standard Error 1.142 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ES (n=2,4,1) | 0.542 Percentage of indices | Standard Error 0.16 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OMS (n=3,5,1) | 43.060 Percentage of indices | Standard Error 16.64 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | CP (n=0,0,0) | NA Percentage of indices | — |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ES (n=2,4,1) | 0.990 Percentage of indices | Standard Error 0.319 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OcS (n=2,4,1) | 0.310 Percentage of indices | Standard Error 0.193 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OV (n=2,4,1) | 2.790 Percentage of indices | Standard Error 0.365 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OMS (n=3,5,1) | 40.900 Percentage of indices | Standard Error 37.209 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | OS (n=2,4,1) | 23.870 Percentage of indices | Standard Error 4.372 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | BV (n=2,4,1) | 21.590 Percentage of indices | Standard Error 6.905 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | MS (n=2,4,1) | 9.780 Percentage of indices | Standard Error 2.283 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | ObS (n=2,4,1) | 7.260 Percentage of indices | Standard Error 2.97 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: BV, OV, OS, OcS, ObS, MS, ES, OMS, CP | CP (n=0,0,0) | NA Percentage of indices | — |
Comparison: BV: P value was calculated using ANOVA.p-value: 0.7ANOVA
Comparison: BV: P value was calculated using ANOVA.p-value: 0.65ANOVA
Comparison: OV: P value was calculated using ANOVA.p-value: 0.006ANOVA
Comparison: OV: P value was calculated using ANOVA.p-value: 0.01ANOVA
Comparison: OS: P value was calculated using ANOVA.p-value: 0.05ANOVA
Comparison: OS: P value was calculated using ANOVA.p-value: 0.045ANOVA
Comparison: OcS: P value was calculated using ANOVA.p-value: 0.18ANOVA
Comparison: OcS: P value was calculated using ANOVA.p-value: 0.56ANOVA
Comparison: ObS: P value was calculated using ANOVA.p-value: 0.14ANOVA
Comparison: ObS: P value was calculated using ANOVA.p-value: 0.22ANOVA
Comparison: MS: P value was calculated using ANOVA.p-value: 0.11ANOVA
Comparison: MS: P value was calculated using ANOVA.p-value: 0.055ANOVA
Comparison: ES: P value was calculated using ANOVA.p-value: 0.069ANOVA
Comparison: ES: P value was calculated using ANOVA.p-value: 0.28ANOVA
Comparison: OMS: P value was calculated using ANOVA.p-value: 0.62ANOVA
Comparison: OMS: P value was calculated using ANOVA.p-value: 0.96ANOVA
Secondary
Bone Histomorphometric Indices at Month 60: MAR
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineral Apposition Rate (MAR). MAR is the area of new bone formed during the label interval.
Time frame: Month 60
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: MAR | 0.525 mcm/d | Standard Error 0.095 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: MAR | 0.573 mcm/d | Standard Error 0.067 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: MAR | 0.490 mcm/d | Standard Error 0.134 |
p-value: 0.7ANOVA
p-value: 0.61ANOVA
Secondary
Bone Histomorphometric Indices at Month 60: Mlt
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Mineralization Lag Time (Mlt). Mineralization lag time was the lag between the time osteoid was formed and the mineral was added.
Time frame: Month 60
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: Mlt | 43.450 days | Standard Error 21.817 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: Mlt | 51.100 days | Standard Error 15.427 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: Mlt | 31.900 days | Standard Error 30.855 |
p-value: 0.79ANOVA
p-value: 0.61ANOVA
Secondary
Bone Histomorphometric Indices at Month 60: SuD
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Surface Density (SuD).
Time frame: Month 60
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: SuD | 2.625 square millimeter per cubic millimeter | Standard Error 0.338 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: SuD | 2.248 square millimeter per cubic millimeter | Standard Error 0.239 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: SuD | 3.120 square millimeter per cubic millimeter | Standard Error 0.479 |
p-value: 0.41ANOVA
p-value: 0.18ANOVA
Secondary
Bone Histomorphometric Indices at Month 60: TbN
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD Calculated indices included: Trabecular Number (TbN). TbN= Ratio of bone volume to tissue volume divided by trabecular thickness.
Time frame: Month 60
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: TbN | 1.315 ratio/mm | Standard Error 0.168 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: TbN | 1.125 ratio/mm | Standard Error 0.119 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: TbN | 1.560 ratio/mm | Standard Error 0.238 |
p-value: 0.41ANOVA
p-value: 0.18ANOVA
Secondary
Bone Histomorphometric Indices at Month 60: TSG
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: Total Surface (Goldner Slide) \[TSG\]. All specimens were demineralized and subjected to staining procedures (Goldner's staining). Slides were analyzed using light microscopy for total surface area, the surface area that consisted of bone and the surface area that consisted of graft material (all in mm\^2 and expressed as percent (%) of the total surface.
Time frame: Month 60
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: TSG | 75.333 mm | Standard Error 30.542 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: TSG | 75.560 mm | Standard Error 23.658 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: TSG | 128.500 mm | Standard Error 52.9 |
p-value: 1ANOVA
p-value: 0.4ANOVA
Secondary
Bone Histomorphometric Indices at Month 60: TtAr
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated variable: Tissue Area (TtAr). Tissue area comprised of the porous calcified substance from which bones were made.
Time frame: Month 60
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: TtAr | 28.767 mm^2 | Standard Error 12.993 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: TtAr | 34.600 mm^2 | Standard Error 10.064 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: TtAr | 41.200 mm^2 | Standard Error 22.504 |
p-value: 0.73ANOVA
p-value: 0.8ANOVA
Secondary
Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh
Bone histomorphometry verified rate of bone remodeling. Anterior iliac crest bone biopsy done to exclude presence of osteomalacia or more subtle defects in mineralization; investigated qualitative aspects of bone. Also assessed decrease in rate of bone turnover, investigated mechanism for observed increase in BMD. Calculated indices included: WTh, OTh, TbTh, TbSp and CTh. Trabecular separation defined as the thickness of the spaces as defined by binarization within the volume of interest.
Time frame: Month 60
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline data and at least one valid bone histomorphometry while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | TbSp (n=2,4,1) | 748.000 mcm | Standard Error 161.893 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | TbTh (n=2,4,1) | 154.500 mcm | Standard Error 29.636 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | WTh (n=2,4,1) | 34.250 mcm | Standard Error 0.833 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | OTh (n=2,4,1) | 7.450 mcm | Standard Error 0.571 |
| Bazedoxifene 20 mg (Core+SE I) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | CTh (n=0,0,0) | NA mcm | — |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | TbTh (n=2,4,1) | 153.000 mcm | Standard Error 20.956 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | WTh (n=2,4,1) | 30.300 mcm | Standard Error 0.589 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | OTh (n=2,4,1) | 5.500 mcm | Standard Error 0.404 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | TbSp (n=2,4,1) | 920.750 mcm | Standard Error 114.476 |
| Bazedoxifene 40 mg (Core) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | CTh (n=0,0,0) | NA mcm | — |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | CTh (n=0,0,0) | NA mcm | — |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | TbSp (n=2,4,1) | 628.000 mcm | Standard Error 228.951 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | WTh (n=2,4,1) | 28.700 mcm | Standard Error 1.177 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | TbTh (n=2,4,1) | 139.000 mcm | Standard Error 41.912 |
| Raloxifene 60 mg (Core) | Bone Histomorphometric Indices at Month 60: WTh, OTh, TbTh, TbSp and CTh | OTh (n=2,4,1) | 6.400 mcm | Standard Error 0.807 |
Comparison: WTh: P value was calculated using ANOVA.p-value: 0.018ANOVA
Comparison: WTh: P value was calculated using ANOVA.p-value: 0.29ANOVA
Comparison: OTh: P value was calculated using ANOVA.p-value: 0.049ANOVA
Comparison: OTh: P value was calculated using ANOVA.p-value: 0.37ANOVA
Comparison: TbTh: P value was calculated using ANOVA.p-value: 0.97ANOVA
Comparison: TbTh: P value was calculated using ANOVA.p-value: 0.78ANOVA
Comparison: TbSp: P value was calculated using ANOVA.p-value: 0.43ANOVA
Comparison: TbSp: P value was calculated using ANOVA.p-value: 0.32ANOVA
Secondary
Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Time frame: Baseline, Months 12, 24, 36
Population: ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Change at Month 12 (n=1490,1438,1455,1495) | -0.24 Units on a scale | Standard Error 0.23 |
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Change at Month 36 (n=1155,1136,1168,1176) | 0.62 Units on a scale | Standard Error 0.3 |
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Change at Month 24 (n=1305,1276,1307,1312) | -0.00 Units on a scale | Standard Error 0.27 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Change at Month 12 (n=1490,1438,1455,1495) | -0.91 Units on a scale | Standard Error 0.24 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Change at Month 36 (n=1155,1136,1168,1176) | -0.11 Units on a scale | Standard Error 0.3 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Change at Month 24 (n=1305,1276,1307,1312) | 0.02 Units on a scale | Standard Error 0.28 |
| Raloxifene 60 mg (Core) | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Change at Month 24 (n=1305,1276,1307,1312) | 0.29 Units on a scale | Standard Error 0.27 |
| Raloxifene 60 mg (Core) | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Change at Month 12 (n=1490,1438,1455,1495) | -0.49 Units on a scale | Standard Error 0.24 |
| Raloxifene 60 mg (Core) | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Change at Month 36 (n=1155,1136,1168,1176) | 0.26 Units on a scale | Standard Error 0.3 |
| Placebo (Core+SE I+SE II) | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Change at Month 12 (n=1490,1438,1455,1495) | -0.77 Units on a scale | Standard Error 0.23 |
| Placebo (Core+SE I+SE II) | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Change at Month 36 (n=1155,1136,1168,1176) | -0.35 Units on a scale | Standard Error 0.3 |
| Placebo (Core+SE I+SE II) | Change From Baseline in European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) at Month 12, 24 and 36 | Change at Month 24 (n=1305,1276,1307,1312) | -0.39 Units on a scale | Standard Error 0.27 |
Comparison: Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.08ANOVA
Comparison: Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.41ANOVA
Comparison: Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.65ANOVA
Comparison: Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.18ANOVA
Comparison: Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.36ANOVA
Comparison: Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.27ANOVA
Comparison: Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.25ANOVA
Comparison: Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.053ANOVA
Comparison: Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.4ANOVA
Comparison: Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.45ANOVA
Comparison: Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.012ANOVA
Comparison: Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.54ANOVA
Comparison: Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.11ANOVA
Comparison: Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.35ANOVA
Comparison: Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.p-value: 0.34ANOVA
Secondary
Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Time frame: Baseline, Months 12, 24, 36
Population: ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Change at Month 36 (n=1095,1078,1111,1128) | -0.00 Units on a scale | Standard Deviation 0.01 |
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Change at Month 12 (n=1425,1375,1393,1436) | 0.01 Units on a scale | Standard Deviation 0.01 |
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Change at Month 24(n=1243,1220,1240,1267) | 0.00 Units on a scale | Standard Deviation 0.01 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Change at Month 12 (n=1425,1375,1393,1436) | 0.01 Units on a scale | Standard Deviation 0.01 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Change at Month 24(n=1243,1220,1240,1267) | -0.01 Units on a scale | Standard Deviation 0.01 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Change at Month 36 (n=1095,1078,1111,1128) | -0.01 Units on a scale | Standard Deviation 0.01 |
| Raloxifene 60 mg (Core) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Change at Month 12 (n=1425,1375,1393,1436) | 0.01 Units on a scale | Standard Deviation 0.01 |
| Raloxifene 60 mg (Core) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Change at Month 24(n=1243,1220,1240,1267) | -0.01 Units on a scale | Standard Deviation 0.01 |
| Raloxifene 60 mg (Core) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Change at Month 36 (n=1095,1078,1111,1128) | -0.01 Units on a scale | Standard Deviation 0.01 |
| Placebo (Core+SE I+SE II) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Change at Month 36 (n=1095,1078,1111,1128) | -0.00 Units on a scale | Standard Deviation 0.01 |
| Placebo (Core+SE I+SE II) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Change at Month 24(n=1243,1220,1240,1267) | 0.01 Units on a scale | Standard Deviation 0.01 |
| Placebo (Core+SE I+SE II) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score at Month 12, 24 and 36 | Change at Month 12 (n=1425,1375,1393,1436) | 0.01 Units on a scale | Standard Deviation 0.01 |
Comparison: Change at Month 12 in EQ-5D: P value was calculated using ANOVA.p-value: 0.72ANOVA
Comparison: Change at Month 12 in EQ-5D: P value was calculated using ANOVA.p-value: 0.98ANOVA
Comparison: Change at Month 12 in EQ-5D: P value was calculated using ANOVA.p-value: 0.84ANOVA
Comparison: Change at Month 12 in EQ-5D: P value was calculated using ANOVA.p-value: 0.88ANOVA
Comparison: Change at Month 12 in EQ-5D: P value was calculated using ANOVA.p-value: 0.86ANOVA
Comparison: Change at Month 24 in EQ-5D: P value was calculated using ANOVA.p-value: 0.82ANOVA
Comparison: Change at Month 24 in EQ-5D: P value was calculated using ANOVA.p-value: 0.11ANOVA
Comparison: Change at Month 24 in EQ-5D: P value was calculated using ANOVA.p-value: 0.14ANOVA
Comparison: Change at Month 24 in EQ-5D: P value was calculated using ANOVA.p-value: 0.22ANOVA
Comparison: Change at Month 24 in EQ-5D: P value was calculated using ANOVA.p-value: 0.88ANOVA
Comparison: Change at Month 36 in EQ-5D: P value was calculated using ANOVA.p-value: 0.96ANOVA
Comparison: Change at Month 36 in EQ-5D: P value was calculated using ANOVA.p-value: 0.76ANOVA
Comparison: Change at Month 36 in EQ-5D: P value was calculated using ANOVA.p-value: 0.92ANOVA
Comparison: Change at Month 36 in EQ-5D: P value was calculated using ANOVA.p-value: 0.89ANOVA
Comparison: Change at Month 36 in EQ-5D: P value was calculated using ANOVA.p-value: 0.83ANOVA
Secondary
Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Time frame: Baseline, Months 12, 24, 36
Population: ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Change at Month 12 (n=1381,1346,1362,1407) | 1.59 mm | Standard Error 1.23 |
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Change at Month 36 (n=1070,1065,1092,1120) | 5.73 mm | Standard Error 1.74 |
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Change at Month 24 (n=1210,1200,1223,1247) | 0.45 mm | Standard Error 1.39 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Change at Month 12 (n=1381,1346,1362,1407) | 0.12 mm | Standard Error 1.24 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Change at Month 36 (n=1070,1065,1092,1120) | 3.87 mm | Standard Error 1.74 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Change at Month 24 (n=1210,1200,1223,1247) | -1.13 mm | Standard Error 1.4 |
| Raloxifene 60 mg (Core) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Change at Month 24 (n=1210,1200,1223,1247) | -1.63 mm | Standard Error 1.37 |
| Raloxifene 60 mg (Core) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Change at Month 12 (n=1381,1346,1362,1407) | -1.39 mm | Standard Error 1.23 |
| Raloxifene 60 mg (Core) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Change at Month 36 (n=1070,1065,1092,1120) | 1.60 mm | Standard Error 1.71 |
| Placebo (Core+SE I+SE II) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Change at Month 12 (n=1381,1346,1362,1407) | -0.37 mm | Standard Error 1.21 |
| Placebo (Core+SE I+SE II) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Change at Month 36 (n=1070,1065,1092,1120) | 4.66 mm | Standard Error 1.7 |
| Placebo (Core+SE I+SE II) | Change From Baseline in Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Month 12, 24 and 36 | Change at Month 24 (n=1210,1200,1223,1247) | -2.12 mm | Standard Error 1.37 |
Comparison: Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.21ANOVA
Comparison: Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.058ANOVA
Comparison: Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.76ANOVA
Comparison: Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.34ANOVA
Comparison: Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.51ANOVA
Comparison: Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.14ANOVA
Comparison: Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.57ANOVA
Comparison: Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.78ANOVA
Comparison: Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.24ANOVA
Comparison: Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.78ANOVA
Comparison: Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.62ANOVA
Comparison: Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.72ANOVA
Comparison: Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.16ANOVA
Comparison: Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.059ANOVA
Comparison: Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.p-value: 0.3ANOVA
Secondary
Change From Baseline in Height at Month 36
Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
Time frame: Baseline, Month 36
Population: ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in Height at Month 36 | -3.7 millimeter (mm) | Standard Error 0.31 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in Height at Month 36 | -3.9 millimeter (mm) | Standard Error 0.31 |
| Raloxifene 60 mg (Core) | Change From Baseline in Height at Month 36 | -4.5 millimeter (mm) | Standard Error 0.31 |
| Placebo (Core+SE I+SE II) | Change From Baseline in Height at Month 36 | -3.3 millimeter (mm) | Standard Error 0.31 |
p-value: 0.31ANCOVA
p-value: 0.039ANCOVA
p-value: 0.13ANCOVA
p-value: 0.12ANCOVA
p-value: 0.002ANCOVA
Secondary
Change From Baseline in Height at Month 60
Height was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
Time frame: Baseline, Month 60
Population: ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. N (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in Height at Month 60 | -0.50 mm | Standard Error 0.06 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in Height at Month 60 | -0.41 mm | Standard Error 0.06 |
| Raloxifene 60 mg (Core) | Change From Baseline in Height at Month 60 | -0.41 mm | Standard Error 0.06 |
p-value: 0.12ANCOVA
p-value: 0.94ANCOVA
Secondary
Change From Baseline in Height at Month 84
Height (cm) was measured 3 times using standardized Harpenden stadiometer (height based on the middle stadiometer reading was recorded).
Time frame: Baseline, Month 84
Population: mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in Height at Month 84 | -0.68 mm | Standard Deviation 0.1 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in Height at Month 84 | -0.73 mm | Standard Deviation 0.08 |
p-value: 0.26ANCOVA
Secondary
Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36
WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction.Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Time frame: Baseline, Months 12, 24, 36
Population: ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Change at Month 12 (n=1490,1435,1461,1503) | 0.000 Units on a scale | Standard Error 0.003 |
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Change at Month 36 (n=1153,1138,1168,1179) | 0.011 Units on a scale | Standard Error 0.005 |
| Bazedoxifene 20 mg (Core+SE I) | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Change at Month 24 (n=1307,1271,1311,1318) | 0.005 Units on a scale | Standard Error 0.004 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Change at Month 12 (n=1490,1435,1461,1503) | 0.001 Units on a scale | Standard Error 0.003 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Change at Month 36 (n=1153,1138,1168,1179) | -0.000 Units on a scale | Standard Error 0.005 |
| Bazedoxifene 40 mg (Core) | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Change at Month 24 (n=1307,1271,1311,1318) | 0.006 Units on a scale | Standard Error 0.004 |
| Raloxifene 60 mg (Core) | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Change at Month 24 (n=1307,1271,1311,1318) | 0.007 Units on a scale | Standard Error 0.004 |
| Raloxifene 60 mg (Core) | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Change at Month 12 (n=1490,1435,1461,1503) | 0.001 Units on a scale | Standard Error 0.003 |
| Raloxifene 60 mg (Core) | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Change at Month 36 (n=1153,1138,1168,1179) | 0.005 Units on a scale | Standard Error 0.005 |
| Placebo (Core+SE I+SE II) | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Change at Month 12 (n=1490,1435,1461,1503) | -0.005 Units on a scale | Standard Error 0.003 |
| Placebo (Core+SE I+SE II) | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Change at Month 36 (n=1153,1138,1168,1179) | 0.005 Units on a scale | Standard Error 0.005 |
| Placebo (Core+SE I+SE II) | Change From Baseline in Women's Health Questionnaire (WHQ) at Month 12, 24 and 36 | Change at Month 24 (n=1307,1271,1311,1318) | -0.002 Units on a scale | Standard Error 0.004 |
Comparison: Change at Month 12 in WHQ: P value was calculated using ANOVA.p-value: 0.2ANOVA
Comparison: Change at Month 12 in WHQ: P value was calculated using ANOVA.p-value: 0.12ANOVA
Comparison: Change at Month 12 in WHQ: P value was calculated using ANOVA.p-value: 0.17ANOVA
Comparison: Change at Month 12 in WHQ: P value was calculated using ANOVA.p-value: 0.92ANOVA
Comparison: Change at Month 12 in WHQ: P value was calculated using ANOVA.p-value: 0.86ANOVA
Comparison: Change at Month 24 in WHQ: P value was calculated using ANOVA.p-value: 0.18ANOVA
Comparison: Change at Month 24 in WHQ: P value was calculated using ANOVA.p-value: 0.12ANOVA
Comparison: Change at Month 24 in WHQ: P value was calculated using ANOVA.p-value: 0.096ANOVA
Comparison: Change at Month 24 in WHQ: P value was calculated using ANOVA.p-value: 0.76ANOVA
Comparison: Change at Month 24 in WHQ: P value was calculated using ANOVA.p-value: 0.93ANOVA
Comparison: Change at Month 36 in WHQ: P value was calculated using ANOVA.p-value: 0.36ANOVA
Comparison: Change at Month 36 in WHQ: P value was calculated using ANOVA.p-value: 0.34ANOVA
Comparison: Change at Month 36 in WHQ: P value was calculated using ANOVA.p-value: 0.98ANOVA
Comparison: Change at Month 36 in WHQ: P value was calculated using ANOVA.p-value: 0.35ANOVA
Comparison: Change at Month 36 in WHQ: P value was calculated using ANOVA.p-value: 0.35ANOVA
Secondary
European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO)
QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Time frame: Baseline
Population: ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline: Month 12 (n=1490,1438,1455,1495) | 24.57 Units on a scale | Standard Deviation 12.95 |
| Bazedoxifene 20 mg (Core+SE I) | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline: Month 36 (n=1155,1136,1168,1176) | 23.87 Units on a scale | Standard Deviation 12.7 |
| Bazedoxifene 20 mg (Core+SE I) | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline: Month 24 (n=1305,1276,1307,1312) | 24.33 Units on a scale | Standard Deviation 12.75 |
| Bazedoxifene 40 mg (Core) | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline: Month 12 (n=1490,1438,1455,1495) | 24.50 Units on a scale | Standard Deviation 12.7 |
| Bazedoxifene 40 mg (Core) | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline: Month 36 (n=1155,1136,1168,1176) | 24.12 Units on a scale | Standard Deviation 12.42 |
| Bazedoxifene 40 mg (Core) | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline: Month 24 (n=1305,1276,1307,1312) | 24.24 Units on a scale | Standard Deviation 12.58 |
| Raloxifene 60 mg (Core) | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline: Month 24 (n=1305,1276,1307,1312) | 23.80 Units on a scale | Standard Deviation 12.62 |
| Raloxifene 60 mg (Core) | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline: Month 12 (n=1490,1438,1455,1495) | 23.98 Units on a scale | Standard Deviation 12.54 |
| Raloxifene 60 mg (Core) | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline: Month 36 (n=1155,1136,1168,1176) | 23.88 Units on a scale | Standard Deviation 12.51 |
| Placebo (Core+SE I+SE II) | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline: Month 12 (n=1490,1438,1455,1495) | 24.31 Units on a scale | Standard Deviation 12.62 |
| Placebo (Core+SE I+SE II) | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline: Month 36 (n=1155,1136,1168,1176) | 23.97 Units on a scale | Standard Deviation 12.27 |
| Placebo (Core+SE I+SE II) | European Foundation for Osteoporosis Quality of Life Questionnaire (QUALEFFO) | Baseline: Month 24 (n=1305,1276,1307,1312) | 24.29 Units on a scale | Standard Deviation 12.6 |
Secondary
Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Time frame: Baseline
Population: ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline: Month 12 (n=1425,1375,1393,1436) | 0.81 Units on a scale | Standard Deviation 0.2 |
| Bazedoxifene 20 mg (Core+SE I) | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline: Month 36 (n=1095,1078,1111,1128) | 0.82 Units on a scale | Standard Deviation 0.2 |
| Bazedoxifene 20 mg (Core+SE I) | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline: Month 24 (n=1243,1220,1240,1267) | 0.81 Units on a scale | Standard Deviation 0.2 |
| Bazedoxifene 40 mg (Core) | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline: Month 12 (n=1425,1375,1393,1436) | 0.82 Units on a scale | Standard Deviation 0.2 |
| Bazedoxifene 40 mg (Core) | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline: Month 36 (n=1095,1078,1111,1128) | 0.82 Units on a scale | Standard Deviation 0.18 |
| Bazedoxifene 40 mg (Core) | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline: Month 24 (n=1243,1220,1240,1267) | 0.82 Units on a scale | Standard Deviation 0.19 |
| Raloxifene 60 mg (Core) | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline: Month 24 (n=1243,1220,1240,1267) | 0.82 Units on a scale | Standard Deviation 0.19 |
| Raloxifene 60 mg (Core) | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline: Month 12 (n=1425,1375,1393,1436) | 0.82 Units on a scale | Standard Deviation 0.19 |
| Raloxifene 60 mg (Core) | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline: Month 36 (n=1095,1078,1111,1128) | 0.82 Units on a scale | Standard Deviation 0.19 |
| Placebo (Core+SE I+SE II) | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline: Month 12 (n=1425,1375,1393,1436) | 0.81 Units on a scale | Standard Deviation 0.21 |
| Placebo (Core+SE I+SE II) | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline: Month 36 (n=1095,1078,1111,1128) | 0.82 Units on a scale | Standard Deviation 0.2 |
| Placebo (Core+SE I+SE II) | Euro Quality of Life-5 Dimensions (EQ-5D)- Health State Profile Utility Score | Baseline: Month 24 (n=1243,1220,1240,1267) | 0.81 Units on a scale | Standard Deviation 0.21 |
Secondary
Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Time frame: Baseline
Population: ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline: Month 12 (n=1381,1346,1362,1407) | 79.20 millimeter (mm) | Standard Deviation 18.05 |
| Bazedoxifene 20 mg (Core+SE I) | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline: Month 36 (n=1070,1065,1092,1120) | 79.78 millimeter (mm) | Standard Deviation 18 |
| Bazedoxifene 20 mg (Core+SE I) | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline: Month 24 (n=1210,1200,1223,1247) | 79.11 millimeter (mm) | Standard Deviation 17.99 |
| Bazedoxifene 40 mg (Core) | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline: Month 12 (n=1381,1346,1362,1407) | 80.89 millimeter (mm) | Standard Deviation 39.47 |
| Bazedoxifene 40 mg (Core) | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline: Month 36 (n=1070,1065,1092,1120) | 81.43 millimeter (mm) | Standard Deviation 35.02 |
| Bazedoxifene 40 mg (Core) | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline: Month 24 (n=1210,1200,1223,1247) | 80.73 millimeter (mm) | Standard Deviation 33.66 |
| Raloxifene 60 mg (Core) | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline: Month 24 (n=1210,1200,1223,1247) | 82.86 millimeter (mm) | Standard Deviation 49.89 |
| Raloxifene 60 mg (Core) | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline: Month 12 (n=1381,1346,1362,1407) | 82.23 millimeter (mm) | Standard Deviation 45.23 |
| Raloxifene 60 mg (Core) | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline: Month 36 (n=1070,1065,1092,1120) | 83.50 millimeter (mm) | Standard Deviation 52.36 |
| Placebo (Core+SE I+SE II) | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline: Month 12 (n=1381,1346,1362,1407) | 80.95 millimeter (mm) | Standard Deviation 32.47 |
| Placebo (Core+SE I+SE II) | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline: Month 36 (n=1070,1065,1092,1120) | 81.07 millimeter (mm) | Standard Deviation 31.54 |
| Placebo (Core+SE I+SE II) | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline: Month 24 (n=1210,1200,1223,1247) | 80.79 millimeter (mm) | Standard Deviation 31.66 |
Secondary
Incidence of Breast Cancer Through Month 36
Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).
Time frame: Baseline through Month 36
Population: Safety Population 1 (SP1) included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Incidence of Breast Cancer Through Month 36 | 1.09 Breast cancer per 1000-women years |
| Bazedoxifene 40 mg (Core) | Incidence of Breast Cancer Through Month 36 | 0.90 Breast cancer per 1000-women years |
| Raloxifene 60 mg (Core) | Incidence of Breast Cancer Through Month 36 | 1.55 Breast cancer per 1000-women years |
| Placebo (Core+SE I+SE II) | Incidence of Breast Cancer Through Month 36 | 1.74 Breast cancer per 1000-women years |
Comparison: P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.p-value: 0.495% CI: [0.203, 1.903]Regression, Logistic
Comparison: P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.p-value: 0.2695% CI: [0.151, 1.676]Regression, Logistic
Comparison: P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.p-value: 0.3395% CI: [0.157, 1.86]Regression, Logistic
Comparison: P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.p-value: 0.4995% CI: [0.206, 2.118]Regression, Logistic
Comparison: P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.p-value: 0.7695% CI: [0.305, 2.37]Regression, Logistic
Comparison: P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.p-value: 0.7595% CI: [0.332, 4.616]Regression, Logistic
Secondary
Incidence of Breast Cancer Through Month 60
Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).
Time frame: Baseline through Month 60
Population: SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Incidence of Breast Cancer Through Month 60 | 1.40 Breast cancer per 1000-women years |
| Bazedoxifene 40 mg (Core) | Incidence of Breast Cancer Through Month 60 | 1.56 Breast cancer per 1000-women years |
| Raloxifene 60 mg (Core) | Incidence of Breast Cancer Through Month 60 | 1.43 Breast cancer per 1000-women years |
Comparison: Relative risk versus placebo was provided together with 95% CIs.95% CI: [0.38, 2.15]
Comparison: Relative risk versus placebo was provided together with 95% CIs.95% CI: [0.39, 2.21]
Secondary
Incidence of Breast Cancer Through Month 84
Incidence of breast cancer was defined as the number of participants with breast cancer diagnosis by the time point of interest divided by the number of participants included in the analysis. The reported rate was rescaled to reflect average follow-up time per 1000 women (1000 multiplied by number of cases divided by total follow-up time).
Time frame: Baseline through Month 84
Population: SP1 included all randomized participants who received at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Incidence of Breast Cancer Through Month 84 | 1.50 Breast cancer per 1000-women years |
| Bazedoxifene 40 mg (Core) | Incidence of Breast Cancer Through Month 84 | 1.52 Breast cancer per 1000-women years |
Comparison: Relative risk versus placebo was provided together with 95% CIs.95% CI: [0.5, 2.06]
Secondary
Number of Participants With Worsening Vertebral Fractures Through Month 36
A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.
Time frame: Baseline through Month 36
Population: ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Number of Participants With Worsening Vertebral Fractures Through Month 36 | 3 Participants |
| Bazedoxifene 40 mg (Core) | Number of Participants With Worsening Vertebral Fractures Through Month 36 | 2 Participants |
| Raloxifene 60 mg (Core) | Number of Participants With Worsening Vertebral Fractures Through Month 36 | 2 Participants |
| Placebo (Core+SE I+SE II) | Number of Participants With Worsening Vertebral Fractures Through Month 36 | 1 Participants |
Secondary
Number of Participants With Worsening Vertebral Fractures Through Month 60
A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.
Time frame: Baseline through Month 60
Population: ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Number of Participants With Worsening Vertebral Fractures Through Month 60 | 4 Participants |
| Bazedoxifene 40 mg (Core) | Number of Participants With Worsening Vertebral Fractures Through Month 60 | 1 Participants |
| Raloxifene 60 mg (Core) | Number of Participants With Worsening Vertebral Fractures Through Month 60 | 2 Participants |
Secondary
Number of Participants With Worsening Vertebral Fractures Through Month 84
A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.
Time frame: Baseline through Month 84
Population: mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Number of Participants With Worsening Vertebral Fractures Through Month 84 | 1 Participants |
| Bazedoxifene 40 mg (Core) | Number of Participants With Worsening Vertebral Fractures Through Month 84 | 7 Participants |
Secondary
Percentage of Participants With New Clinical Vertebral Fractures Through Month 36
A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.
Time frame: Baseline through Month 36
Population: ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 | 0.72 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 | 0.76 Percentage of participants |
| Raloxifene 60 mg (Core) | Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 | 0.87 Percentage of participants |
| Placebo (Core+SE I+SE II) | Percentage of Participants With New Clinical Vertebral Fractures Through Month 36 | 0.94 Percentage of participants |
p-value: 0.57Log Rank
p-value: 0.62Log Rank
p-value: 0.72Log Rank
p-value: 0.67Log Rank
p-value: 0.89Log Rank
p-value: 0.95Log Rank
Secondary
Percentage of Participants With New Clinical Vertebral Fractures Through Month 60
A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.
Time frame: Baseline through Month 60
Population: ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 | 0.79 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 | 1.37 Percentage of participants |
| Raloxifene 60 mg (Core) | Percentage of Participants With New Clinical Vertebral Fractures Through Month 60 | 0.84 Percentage of participants |
p-value: 0.29Log Rank
p-value: 0.31Log Rank
p-value: 0.94Log Rank
Secondary
Percentage of Participants With New Clinical Vertebral Fractures Through Month 84
A new clinical vertebral fracture was defined as a new fracture found at any time because of back pain suggestive of fracture(s). New Clinical vertebral fractures were verified with radiographic assessment using both semi-quantitative and quantitative morphometric assessment: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 mm or more from base to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from T4 to L4, provided vertebra was not fractured at base.
Time frame: Baseline through Month 84
Population: mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With New Clinical Vertebral Fractures Through Month 84 | 1.92 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With New Clinical Vertebral Fractures Through Month 84 | 1.28 Percentage of participants |
p-value: 0.18Log Rank
Secondary
Percentage of Participants With Non-vertebral Fractures Through Month 36
Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.
Time frame: Baseline through Month 36
Population: ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Osteoporosis-Related | 5.68 Percentage of participants |
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Wrist | 2.28 Percentage of participants |
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Hip | 0.55 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Osteoporosis-Related | 5.61 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Wrist | 1.83 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Hip | 0.34 Percentage of participants |
| Raloxifene 60 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Hip | 0.26 Percentage of participants |
| Raloxifene 60 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Osteoporosis-Related | 5.87 Percentage of participants |
| Raloxifene 60 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Wrist | 2.51 Percentage of participants |
| Placebo (Core+SE I+SE II) | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Osteoporosis-Related | 6.26 Percentage of participants |
| Placebo (Core+SE I+SE II) | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Wrist | 1.64 Percentage of participants |
| Placebo (Core+SE I+SE II) | Percentage of Participants With Non-vertebral Fractures Through Month 36 | Hip | 0.31 Percentage of participants |
Comparison: Osteoporosis-Related: P value was calculated using Log-Rank test.p-value: 0.46Log Rank
Comparison: Osteoporosis-Related: P value was calculated using Log-Rank test.p-value: 0.9Log Rank
Comparison: Osteoporosis-Related: P value was calculated using Log-Rank test.p-value: 0.93Log Rank
Comparison: Osteoporosis-Related: P value was calculated using Log-Rank test.p-value: 0.84Log Rank
Comparison: Osteoporosis-Related: P value was calculated using Log-Rank test.p-value: 0.39Log Rank
Comparison: Osteoporosis-Related: P value was calculated using Log-Rank test.p-value: 0.52Log Rank
Comparison: Hip: P value was calculated using Log-Rank test.p-value: 0.28Log Rank
Comparison: Hip: P value was calculated using Log-Rank test.p-value: 0.31Log Rank
Comparison: Hip: P value was calculated using Log-Rank test.p-value: 0.17Log Rank
Comparison: Hip: P value was calculated using Log-Rank test.p-value: 0.72Log Rank
Comparison: Hip: P value was calculated using Log-Rank test.p-value: 0.97Log Rank
Comparison: Hip: P value was calculated using Log-Rank test.p-value: 0.76Log Rank
Comparison: Wrist: P value was calculated using Log-Rank test.p-value: 0.29Log Rank
Comparison: Wrist: P value was calculated using Log-Rank test.p-value: 0.43Log Rank
Comparison: Wrist: P value was calculated using Log-Rank test.p-value: 0.59Log Rank
Comparison: Wrist: P value was calculated using Log-Rank test.p-value: 0.19Log Rank
Comparison: Wrist: P value was calculated using Log-Rank test.p-value: 0.8Log Rank
Comparison: Wrist: P value was calculated using Log-Rank test.p-value: 0.11Log Rank
Secondary
Percentage of Participants With Non-vertebral Fractures Through Month 60
Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.
Time frame: Baseline through Month 60
Population: ITT population for vt fractures:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With Non-vertebral Fractures Through Month 60 | Hip | 0.75 Percentage of participants |
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With Non-vertebral Fractures Through Month 60 | Osteoporosis-Related | 9.47 Percentage of participants |
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With Non-vertebral Fractures Through Month 60 | Wrist | 3.30 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 60 | Hip | 0.65 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 60 | Osteoporosis-Related | 9.03 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 60 | Wrist | 2.79 Percentage of participants |
| Raloxifene 60 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 60 | Osteoporosis-Related | 7.59 Percentage of participants |
| Raloxifene 60 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 60 | Wrist | 2.60 Percentage of participants |
| Raloxifene 60 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 60 | Hip | 0.53 Percentage of participants |
Comparison: Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.96895% CI: [0.79, 1.296]Log Rank
Comparison: Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.21195% CI: [0.652, 1.097]Log Rank
Comparison: Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.19195% CI: [0.925, 1.556]Log Rank
Comparison: Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.49395% CI: [0.566, 3.497]Log Rank
Comparison: Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.8295% CI: [0.316, 2.405]Log Rank
Comparison: Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.37195% CI: [0.624, 4.161]Log Rank
Comparison: Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.42395% CI: [0.776, 1.861]Log Rank
Comparison: Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.79995% CI: [0.587, 1.491]Log Rank
Comparison: Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.29895% CI: [0.818, 2.002]Log Rank
Secondary
Percentage of Participants With Non-vertebral Fractures Through Month 84
Non-vertebral fractures were determined by direct questioning at each clinic visit after medication therapy begins. Osteoporosis-related, hip and wrist fractures were summarized.
Time frame: Baseline through Month 84
Population: mITT population of SP1 population:randomized participants who took at least 1 dose of test article;had vt radiographic assessment at baseline and at least once while on therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With Non-vertebral Fractures Through Month 84 | Osteoporosis-Related | 10.77 Percentage of participants |
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With Non-vertebral Fractures Through Month 84 | Hip | 1.34 Percentage of participants |
| Bazedoxifene 20 mg (Core+SE I) | Percentage of Participants With Non-vertebral Fractures Through Month 84 | Wrist | 3.62 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 84 | Osteoporosis-Related | 11.20 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 84 | Hip | 0.74 Percentage of participants |
| Bazedoxifene 40 mg (Core) | Percentage of Participants With Non-vertebral Fractures Through Month 84 | Wrist | 4.61 Percentage of participants |
Comparison: Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.7395% CI: [0.78, 1.19]Log Rank
Comparison: Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.7195% CI: [0.41, 1.83]Log Rank
Comparison: Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.p-value: 0.4595% CI: [0.8, 1.66]Log Rank
Secondary
Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36
BMD of lumbar spine (Lu Sp) and hip (total hip \[Tl Hp\], femoral neck \[Fe Ne\] and femur trochanter \[Fe Tr\]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.
Time frame: Baseline, Months 6, 12, 18, 24, 36
Population: ITT population included all randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 24 (n=1398,1335,1381,1386) | 1.51 Percent change | Standard Error 0.12 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 18 (n=1489,1437,1463,1484) | 1.54 Percent change | Standard Error 0.12 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 6 (n=1687,1658,1662,1703) | 1.17 Percent change | Standard Error 0.1 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 24 (n=1398,1335,1381,1386) | 0.80 Percent change | Standard Error 0.1 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 24 (n=1400,1347,1387,1398) | 1.99 Percent change | Standard Error 0.11 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 6 (n=1693,1663,1662,1711) | 1.53 Percent change | Standard Error 0.09 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 24 (n=1394,1333,1379,1382) | 0.82 Percent change | Standard Error 0.09 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 6 (n=1684,1653,1659,1699) | 0.75 Percent change | Standard Error 0.07 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 36 (n=1020,1018,1046,1051) | 0.28 Percent change | Standard Error 0.15 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 12 (n=1587,1541,1546,1599) | 2.06 Percent change | Standard Error 0.1 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 12 (n=1578,1532,1532,1586) | 1.07 Percent change | Standard Error 0.07 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 36 (n=1019,1016,1044,1050) | 0.27 Percent change | Standard Error 0.12 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 12 (n=1581,1537,1536,1591) | 0.92 Percent change | Standard Error 0.09 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 36 (n=1020,1018,1046,1051) | 0.89 Percent change | Standard Error 0.17 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 12 (n=1581,1537,1536,1591) | 1.71 Percent change | Standard Error 0.11 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 6 (n=1687,1658,1662,1703) | 0.60 Percent change | Standard Error 0.09 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 36 (n=1022,1029,1050,1054) | 2.21 Percent change | Standard Error 0.16 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 18 (n=1498,1444,1474,1487) | 2.00 Percent change | Standard Error 0.11 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 18 (n=1486,1434,1459,1480) | 0.93 Percent change | Standard Error 0.08 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 18 (n=1489,1437,1463,1484) | 0.80 Percent change | Standard Error 0.1 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 24 (n=1398,1335,1381,1386) | 1.57 Percent change | Standard Error 0.13 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 18 (n=1489,1437,1463,1484) | 1.09 Percent change | Standard Error 0.1 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 36 (n=1020,1018,1046,1051) | 0.67 Percent change | Standard Error 0.15 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 24 (n=1398,1335,1381,1386) | 1.05 Percent change | Standard Error 0.11 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 12 (n=1578,1532,1532,1586) | 1.24 Percent change | Standard Error 0.08 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 18 (n=1489,1437,1463,1484) | 1.64 Percent change | Standard Error 0.12 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 6 (n=1693,1663,1662,1711) | 1.56 Percent change | Standard Error 0.09 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 36 (n=1020,1018,1046,1051) | 0.90 Percent change | Standard Error 0.17 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 18 (n=1486,1434,1459,1480) | 1.13 Percent change | Standard Error 0.08 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 24 (n=1400,1347,1387,1398) | 2.12 Percent change | Standard Error 0.11 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 12 (n=1581,1537,1536,1591) | 1.10 Percent change | Standard Error 0.1 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 24 (n=1394,1333,1379,1382) | 1.01 Percent change | Standard Error 0.09 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 18 (n=1498,1444,1474,1487) | 2.24 Percent change | Standard Error 0.11 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 6 (n=1687,1658,1662,1703) | 1.24 Percent change | Standard Error 0.1 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 36 (n=1022,1029,1050,1054) | 2.38 Percent change | Standard Error 0.16 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 6 (n=1687,1658,1662,1703) | 0.62 Percent change | Standard Error 0.09 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 12 (n=1581,1537,1536,1591) | 1.84 Percent change | Standard Error 0.11 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 12 (n=1587,1541,1546,1599) | 2.13 Percent change | Standard Error 0.1 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 6 (n=1684,1653,1659,1699) | 0.85 Percent change | Standard Error 0.07 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 36 (n=1019,1016,1044,1050) | 0.50 Percent change | Standard Error 0.12 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 24 (n=1400,1347,1387,1398) | 2.74 Percent change | Standard Error 0.11 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 6 (n=1693,1663,1662,1711) | 1.79 Percent change | Standard Error 0.09 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 6 (n=1684,1653,1659,1699) | 1.07 Percent change | Standard Error 0.07 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 6 (n=1687,1658,1662,1703) | 0.52 Percent change | Standard Error 0.09 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 6 (n=1687,1658,1662,1703) | 1.49 Percent change | Standard Error 0.1 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 12 (n=1587,1541,1546,1599) | 2.50 Percent change | Standard Error 0.1 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 12 (n=1578,1532,1532,1586) | 1.50 Percent change | Standard Error 0.08 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 12 (n=1581,1537,1536,1591) | 1.27 Percent change | Standard Error 0.1 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 12 (n=1581,1537,1536,1591) | 2.14 Percent change | Standard Error 0.11 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 18 (n=1498,1444,1474,1487) | 2.58 Percent change | Standard Error 0.11 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 18 (n=1486,1434,1459,1480) | 1.47 Percent change | Standard Error 0.08 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 18 (n=1489,1437,1463,1484) | 1.21 Percent change | Standard Error 0.1 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 18 (n=1489,1437,1463,1484) | 2.18 Percent change | Standard Error 0.12 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 24 (n=1394,1333,1379,1382) | 1.37 Percent change | Standard Error 0.09 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 24 (n=1398,1335,1381,1386) | 1.37 Percent change | Standard Error 0.1 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 24 (n=1398,1335,1381,1386) | 2.18 Percent change | Standard Error 0.13 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 36 (n=1022,1029,1050,1054) | 2.96 Percent change | Standard Error 0.16 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 36 (n=1019,1016,1044,1050) | 0.90 Percent change | Standard Error 0.12 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 36 (n=1020,1018,1046,1051) | 0.80 Percent change | Standard Error 0.15 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 36 (n=1020,1018,1046,1051) | 1.62 Percent change | Standard Error 0.17 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 18 (n=1486,1434,1459,1480) | -0.07 Percent change | Standard Error 0.08 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 18 (n=1498,1444,1474,1487) | 0.52 Percent change | Standard Error 0.11 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 36 (n=1020,1018,1046,1051) | -1.30 Percent change | Standard Error 0.15 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 24 (n=1398,1335,1381,1386) | 0.01 Percent change | Standard Error 0.13 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 12 (n=1581,1537,1536,1591) | 0.63 Percent change | Standard Error 0.11 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 12 (n=1581,1537,1536,1591) | 0.08 Percent change | Standard Error 0.09 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 6 (n=1684,1653,1659,1699) | 0.24 Percent change | Standard Error 0.06 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 36 (n=1022,1029,1050,1054) | 0.88 Percent change | Standard Error 0.16 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 12 (n=1578,1532,1532,1586) | 0.28 Percent change | Standard Error 0.07 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 12 (n=1587,1541,1546,1599) | 0.61 Percent change | Standard Error 0.1 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 6 (n=1693,1663,1662,1711) | 0.51 Percent change | Standard Error 0.09 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 36 (n=1019,1016,1044,1050) | -0.83 Percent change | Standard Error 0.12 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 6 (n=1687,1658,1662,1703) | 0.33 Percent change | Standard Error 0.1 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Lu Sp:Change at Month 24 (n=1400,1347,1387,1398) | 0.47 Percent change | Standard Error 0.11 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 6 (n=1687,1658,1662,1703) | -0.05 Percent change | Standard Error 0.09 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Tl Hp:Change at Month 24 (n=1394,1333,1379,1382) | -0.35 Percent change | Standard Error 0.09 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 18 (n=1489,1437,1463,1484) | 0.14 Percent change | Standard Error 0.12 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 18 (n=1489,1437,1463,1484) | -0.24 Percent change | Standard Error 0.1 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Tr:Change at Month 36 (n=1020,1018,1046,1051) | -0.50 Percent change | Standard Error 0.17 |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24 and 36 | Fe Ne:Change at Month 24 (n=1398,1335,1381,1386) | -0.58 Percent change | Standard Error 0.1 |
Comparison: Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in lumbar spine BMD: P value was calculated using Analysis of covariance (ANCOVA).p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: 0.018ANCOVA
Comparison: Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: 0.036ANCOVA
Comparison: Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: 0.003ANCOVA
Comparison: Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: 0.019ANCOVA
Comparison: Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: 0.002ANCOVA
Comparison: Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.p-value: 0.008ANCOVA
Comparison: Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.p-value: 0.007ANCOVA
Comparison: Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.p-value: 0.002ANCOVA
Comparison: Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.p-value: 0.002ANCOVA
Comparison: Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.p-value: 0.006ANCOVA
Comparison: Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.p-value: 0.47ANCOVA
Comparison: Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.p-value: 0.005ANCOVA
Comparison: Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.p-value: 0.002ANCOVA
Comparison: Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.p-value: 0.004ANCOVA
Comparison: Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.p-value: 0.39ANCOVA
Comparison: Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.p-value: 0.17ANCOVA
Comparison: Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.p-value: 0.34ANCOVA
Comparison: Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.p-value: 0.016ANCOVA
Comparison: Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.p-value: 0.47ANCOVA
Comparison: Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: 0.01ANCOVA
Comparison: Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: 0.002ANCOVA
Comparison: Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: 0.048ANCOVA
Comparison: Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: 0.038ANCOVA
Comparison: Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Secondary
Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60
BMD of lumbar spine (Lu Sp) and hip (total hip \[Tl Hp\], femoral neck \[Fe Ne\] and femur trochanter \[Fe Tr\]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.
Time frame: Baseline, Month 48, 60
Population: mITT population of SP1 population:randomized participants who took at least 1 dose of test article; had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable for this measure.n=participants with specified baseline fracture status evaluable for each group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Lu Sp:Change at Month 48 (n=886,876,886) | 1.92 Percent change | Standard Error 0.22 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Tl Hp:Change at Month 48 (n=877,865,868) | -0.17 Percent change | Standard Error 0.18 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Fe Ne:Change at Month 48 (n=879,866,870) | 0.02 Percent change | Standard Error 0.2 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Fe Tr:Change at Month 48 (n=879,734,870) | 0.18 Percent change | Standard Error 0.24 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Lu Sp:Change at Month 60 (n=742,747,746) | 2.16 Percent change | Standard Error 0.26 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Tl Hp:Change at Month 60 (n=738,733,736) | -0.48 Percent change | Standard Error 0.21 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Fe Ne:Change at Month 60 (n=740,734,737) | -0.18 Percent change | Standard Error 0.25 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Fe Tr:Change at Month 60 (n= 740,734,737) | -0.13 Percent change | Standard Error 0.29 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Fe Ne:Change at Month 48 (n=879,866,870) | -1.30 Percent change | Standard Error 0.2 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Fe Ne:Change at Month 60 (n=740,734,737) | -1.72 Percent change | Standard Error 0.25 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Fe Tr:Change at Month 48 (n=879,734,870) | -0.81 Percent change | Standard Error 0.25 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Lu Sp:Change at Month 60 (n=742,747,746) | 1.46 Percent change | Standard Error 0.26 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Tl Hp:Change at Month 60 (n=738,733,736) | -1.49 Percent change | Standard Error 0.21 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Lu Sp:Change at Month 48 (n=886,876,886) | 0.84 Percent change | Standard Error 0.22 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Tl Hp:Change at Month 48 (n=877,865,868) | -1.05 Percent change | Standard Error 0.18 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Fe Tr:Change at Month 60 (n= 740,734,737) | -1.19 Percent change | Standard Error 0.29 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Fe Ne:Change at Month 48 (n=879,866,870) | 0.45 Percent change | Standard Error 0.2 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Tl Hp:Change at Month 48 (n=877,865,868) | 0.11 Percent change | Standard Error 0.18 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Lu Sp:Change at Month 48 (n=886,876,886) | 2.02 Percent change | Standard Error 0.22 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Fe Tr:Change at Month 48 (n=879,734,870) | 0.45 Percent change | Standard Error 0.25 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Fe Ne:Change at Month 60 (n=740,734,737) | 0.09 Percent change | Standard Error 0.25 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Tl Hp:Change at Month 60 (n=738,733,736) | -0.29 Percent change | Standard Error 0.21 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Lu Sp:Change at Month 60 (n=742,747,746) | 2.08 Percent change | Standard Error 0.26 |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 48, 60 | Fe Tr:Change at Month 60 (n= 740,734,737) | -0.00 Percent change | Standard Error 0.29 |
Comparison: Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: 0.01ANCOVA
Comparison: Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: 0.023ANCOVA
Comparison: Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Secondary
Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84
BMD of lumbar spine (Lu Sp) and hip (total hip \[Tl Hp\], femoral neck \[Fe Ne\] and femur trochanter \[Fe Tr\]) was evaluated by dual-energy x-ray absorptiometry (DXA). The left hip was evaluated unless prevented by pathology, in which case the right hip was evaluated throughout the study. Results were scored as T score, defined as BMD at the site when compared to the young normal reference mean. Normal BMD is a T-score of -1.0 or higher.
Time frame: Baseline, Month 72, 84
Population: Modified ITT(mITT) population of SP1 population:randomized participants who took at least 1 dose of test article;had baseline BMD and at least one valid BMD while on therapy. N (number of participants analyzed)=participants evaluable.n=participants with specified baseline fracture status.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Lu Sp:Change at Month 72 (n=457,888) | 1.80 Percent change | Standard Deviation 0.4 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Tl Hp:Change at Month 72 (n=448,871) | -1.96 Percent change | Standard Deviation 0.33 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Fe Ne:Change at Month 72 (n=448,871) | -2.12 Percent change | Standard Deviation 0.39 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Fe Tr:Change at Month 72 (n=448,871) | -1.43 Percent change | Standard Deviation 0.44 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Lu Sp:Change at Month 84 (n=417,800) | 2.19 Percent change | Standard Deviation 0.49 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Tl Hp:Change at Month 84 (n=405,787) | -2.53 Percent change | Standard Deviation 0.38 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Fe Ne:Change at Month 84 (n=405,787) | -2.35 Percent change | Standard Deviation 0.43 |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Fe Tr:Change at Month 84 (n=405,787) | -2.72 Percent change | Standard Deviation 0.47 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Fe Tr:Change at Month 84 (n=405,787) | -1.41 Percent change | Standard Deviation 0.38 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Lu Sp:Change at Month 72 (n=457,888) | 2.24 Percent change | Standard Deviation 0.31 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Lu Sp:Change at Month 84 (n=417,800) | 2.95 Percent change | Standard Deviation 0.39 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Tl Hp:Change at Month 72 (n=448,871) | -0.85 Percent change | Standard Deviation 0.25 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Fe Ne:Change at Month 84 (n=405,787) | -0.80 Percent change | Standard Deviation 0.35 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Fe Ne:Change at Month 72 (n=448,871) | -0.60 Percent change | Standard Deviation 0.3 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Tl Hp:Change at Month 84 (n=405,787) | -1.15 Percent change | Standard Deviation 0.3 |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Bone Mineral Density (BMD) at Months 72 and 84 | Fe Tr:Change at Month 72 (n=448,871) | -0.31 Percent change | Standard Deviation 0.34 |
Comparison: Percent change at Month 72 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: 0.34ANCOVA
Comparison: Percent change at Month 84 in lumbar spine BMD: P value was calculated using ANCOVA.p-value: 0.15ANCOVA
Comparison: Percent change at Month 72 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 84 in total hip BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 72 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 84 in femoral neck BMD: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 72 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: 0.003ANCOVA
Comparison: Percent change at Month 84 in femoral trochanter BMD: P value was calculated using ANCOVA.p-value: 0.002ANCOVA
Secondary
Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12
C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.
Time frame: Baseline, Months 3, 6, 12
Population: ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Change at Month 3 (n=1739,1708,1703,1746) | -42.12 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Change at Month 12 (n=1565,1522,1530,1573) | -45.64 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Change at Month 6 (n=1655,1634,1634,1681) | -46.93 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Change at Month 3 (n=1739,1708,1703,1746) | -45.11 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Change at Month 12 (n=1565,1522,1530,1573) | -48.77 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Change at Month 6 (n=1655,1634,1634,1681) | -50.00 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Change at Month 6 (n=1655,1634,1634,1681) | -52.55 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Change at Month 3 (n=1739,1708,1703,1746) | -45.48 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Change at Month 12 (n=1565,1522,1530,1573) | -54.55 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Change at Month 3 (n=1739,1708,1703,1746) | -26.17 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Change at Month 12 (n=1565,1522,1530,1573) | -27.31 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in C-telopeptide (CTx) at Month 3, 6 and 12 | Change at Month 6 (n=1655,1634,1634,1681) | -27.94 Percent change |
Comparison: Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: 0.4Ranked ANCOVA
Comparison: Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: 0.004Ranked ANCOVA
Comparison: Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Secondary
Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60
C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.
Time frame: Baseline, Months 36, 60
Population: mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 | Change at Month 36 (n=178,180,168) | -30.54 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 | Change at Month 60 (n=127,131,126) | -26.80 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 | Change at Month 36 (n=178,180,168) | -21.85 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 | Change at Month 60 (n=127,131,126) | -10.40 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 | Change at Month 36 (n=178,180,168) | -32.26 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in C-telopeptide (CTx) at Months 36 and 60 | Change at Month 60 (n=127,131,126) | -27.87 Percent change |
Comparison: Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: 0.001Ranked ANCOVA
Comparison: Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: 0.009Ranked ANCOVA
Secondary
Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84
C-telopeptide is a biochemical marker of bone formation. Blood samples were collected to evaluate C-telopeptide levels.
Time frame: Baseline, Months 72, 84
Population: mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84 | Change at Month 72 (n=97,170) | -29.44 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84 | Change at Month 84 (n=84,147) | -28.61 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84 | Change at Month 72 (n=97,170) | -37.41 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in C-telopeptide (CTx) at Months 72 and 84 | Change at Month 84 (n=84,147) | -28.17 Percent change |
Comparison: Percent change at Month 72 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: 0.034Ranked ANCOVA
Comparison: Percent change at Month 84 in C-telopeptide: P value was calculated using Ranked ANCOVA.p-value: 0.77Ranked ANCOVA
Secondary
Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36
Lipid parameters evaluated included total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), triglyceride (TG), high-density lipoprotein fraction 2 (HDL2) and high-density lipoprotein fraction 3 (HDL3).
Time frame: Baseline, Months 6, 12, 24, 36
Population: ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 12 (n=1556,1515,1536,1578) | -4.14 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 6 (n=1647,1623,1627,1674) | -8.55 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 6 (n=1647,1619,1626,1671) | 1.43 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 6 (n=1643,1618,1623,1666) | -13.89 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 6 (n=1643,1619,1625,1668) | 9.38 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 6 (n=1646,1623,1628,1673) | 4.28 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 6 (n=1646,1623,1628,1673) | -3.89 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 12 (n=1559,1516,1534,1578) | -7.79 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 12 (n=1552,1513,1531,1576) | 1.14 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 12 (n=1550,1510,1528,1570) | -16.55 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 12 (n=1551,1511,1531,1572) | 9.85 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 12 (n=1556,1515,1535,1578) | 5.95 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 24 (n=1378,1341,1377,1385) | -4.17 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 24 (n=1379,1341,1376,1384) | -4.51 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 24 (n=1377,1338,1374,1382) | 3.57 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 24 (n=1369,1336,1363,1377) | -10.26 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 24 (n=1370,1337,1365,1379) | 10.81 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 24 (n=1378,1341,1377,1385) | 4.23 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 36 (n=1220,1201,1225,1248) | -3.75 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 36 (n=1220,1201,1223,1247) | -5.36 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 36 (n=1216,1196,1219,1246) | 5.10 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 36 (n=1209,1191,1214,1236) | -19.51 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 36 (n=1210,1194,1218,1237) | 18.18 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 36 (n=1220,1201,1225,1248) | 8.48 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 36 (n=1220,1201,1225,1248) | 13.59 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 24 (n=1378,1341,1377,1385) | -4.72 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 6 (n=1643,1618,1623,1666) | -11.86 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 36 (n=1210,1194,1218,1237) | 17.93 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 36 (n=1209,1191,1214,1236) | -17.07 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 24 (n=1379,1341,1376,1384) | -5.94 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 12 (n=1552,1513,1531,1576) | 0.66 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 24 (n=1370,1337,1365,1379) | 10.77 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 6 (n=1646,1623,1628,1673) | 7.14 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 24 (n=1377,1338,1374,1382) | 2.42 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 6 (n=1647,1619,1626,1671) | 1.06 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 24 (n=1369,1336,1363,1377) | -11.94 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 36 (n=1216,1196,1219,1246) | 5.93 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 12 (n=1550,1510,1528,1570) | -16.33 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 36 (n=1220,1201,1223,1247) | -6.63 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 6 (n=1647,1623,1627,1674) | -10.18 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 12 (n=1559,1516,1534,1578) | -8.45 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 12 (n=1551,1511,1531,1572) | 10.00 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 12 (n=1556,1515,1536,1578) | -3.66 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 36 (n=1220,1201,1225,1248) | -3.47 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 6 (n=1646,1623,1628,1673) | -4.73 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 12 (n=1556,1515,1535,1578) | 8.14 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 6 (n=1643,1619,1625,1668) | 8.60 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 24 (n=1378,1341,1377,1385) | 8.09 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 12 (n=1551,1511,1531,1572) | 9.52 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 12 (n=1556,1515,1536,1578) | -5.18 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 12 (n=1559,1516,1534,1578) | -10.28 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 12 (n=1552,1513,1531,1576) | 0.58 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 12 (n=1550,1510,1528,1570) | -17.54 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 36 (n=1216,1196,1219,1246) | 5.00 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 36 (n=1220,1201,1223,1247) | -8.51 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 12 (n=1556,1515,1535,1578) | 6.25 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 24 (n=1378,1341,1377,1385) | -5.68 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 24 (n=1379,1341,1376,1384) | -7.30 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 36 (n=1209,1191,1214,1236) | -18.47 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 24 (n=1377,1338,1374,1382) | 2.41 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 24 (n=1369,1336,1363,1377) | -13.04 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 36 (n=1220,1201,1225,1248) | 12.21 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 24 (n=1370,1337,1365,1379) | 10.99 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 24 (n=1378,1341,1377,1385) | 5.17 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 36 (n=1210,1194,1218,1237) | 17.14 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 6 (n=1646,1623,1628,1673) | -5.50 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 6 (n=1647,1623,1627,1674) | -11.52 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 36 (n=1220,1201,1225,1248) | -5.04 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 6 (n=1647,1619,1626,1671) | 0.00 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 6 (n=1643,1618,1623,1666) | -14.75 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 6 (n=1643,1619,1625,1668) | 8.70 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 6 (n=1646,1623,1628,1673) | 5.71 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 36 (n=1210,1194,1218,1237) | 13.33 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 36 (n=1216,1196,1219,1246) | 2.51 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 12 (n=1559,1516,1534,1578) | 0.66 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 6 (n=1646,1623,1628,1673) | 0.00 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 12 (n=1551,1511,1531,1572) | 6.38 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 12 (n=1550,1510,1528,1570) | -14.29 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 6 (n=1646,1623,1628,1673) | 4.90 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 6 (n=1647,1623,1627,1674) | -1.17 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 6 (n=1643,1619,1625,1668) | 6.90 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 12 (n=1552,1513,1531,1576) | -1.17 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 36 (n=1220,1201,1223,1247) | 1.55 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 6 (n=1647,1619,1626,1671) | 0.00 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 36 (n=1209,1191,1214,1236) | -18.66 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL:Change at Month 24 (n=1377,1338,1374,1382) | 1.63 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 36 (n=1220,1201,1225,1248) | 0.34 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 24 (n=1369,1336,1363,1377) | -10.61 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 36 (n=1220,1201,1225,1248) | 12.11 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | LDL:Change at Month 24 (n=1379,1341,1376,1384) | 4.41 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 12 (n=1556,1515,1536,1578) | 0.87 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL3:Change at Month 24 (n=1370,1337,1365,1379) | 6.98 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TC:Change at Month 24 (n=1378,1341,1377,1385) | 0.38 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 12 (n=1556,1515,1535,1578) | 7.99 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | HDL2:Change at Month 6 (n=1643,1618,1623,1666) | -12.22 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Lipid Parameters at Months 6, 12, 24 and 36 | TG:Change at Month 24 (n=1378,1341,1377,1385) | 6.19 Percent change |
Comparison: Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.p-value: 0.001ANCOVA
Comparison: Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.p-value: 0.009ANCOVA
Comparison: Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.p-value: 0.055ANCOVA
Comparison: Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.p-value: 0.004ANCOVA
Comparison: Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in LDL: P value was calculated using ANCOVA.p-value: 0.012ANCOVA
Comparison: Percent change at Month 12 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in LDL: P value was calculated using ANCOVA.p-value: 0.031ANCOVA
Comparison: Percent change at Month 36 in LDL: P value was calculated using ANCOVA.p-value: 0.008ANCOVA
Comparison: Percent change at Month 6 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in LDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in HDL: P value was calculated using ANCOVA.p-value: 0.001ANCOVA
Comparison: Percent change at Month 12 in HDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in HDL: P value was calculated using ANCOVA.p-value: 0.001ANCOVA
Comparison: Percent change at Month 36 in HDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in HDL: P value was calculated using ANCOVA.p-value: 0.1ANCOVA
Comparison: Percent change at Month 12 in HDL: P value was calculated using ANCOVA.p-value: 0.89ANCOVA
Comparison: Percent change at Month 24 in HDL: P value was calculated using ANCOVA.p-value: 0.6ANCOVA
Comparison: Percent change at Month 36 in HDL: P value was calculated using ANCOVA.p-value: 0.82ANCOVA
Comparison: Percent change at Month 6 in HDL: P value was calculated using ANCOVA.p-value: 0.001ANCOVA
Comparison: Percent change at Month 12 in HDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in HDL: P value was calculated using ANCOVA.p-value: 0.012ANCOVA
Comparison: Percent change at Month 36 in HDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in HDL: P value was calculated using ANCOVA.p-value: 0.083ANCOVA
Comparison: Percent change at Month 12 in HDL: P value was calculated using ANCOVA.p-value: 0.96ANCOVA
Comparison: Percent change at Month 24 in HDL: P value was calculated using ANCOVA.p-value: 0.84ANCOVA
Comparison: Percent change at Month 36 in HDL: P value was calculated using ANCOVA.p-value: 0.15ANCOVA
Comparison: Percent change at Month 6 in HDL: P value was calculated using ANCOVA.p-value: 0.13ANCOVA
Comparison: Percent change at Month 12 in HDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in HDL: P value was calculated using ANCOVA.p-value: 0.007ANCOVA
Comparison: Percent change at Month 36 in HDL: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.p-value: 0.28ANCOVA
Comparison: Percent change at Month 12 in HDL2: P value was calculated using ANCOVAp-value: 0.1ANCOVA
Comparison: Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.p-value: 0.94ANCOVA
Comparison: Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.p-value: 0.46ANCOVA
Comparison: Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.p-value: 0.63ANCOVA
Comparison: Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.p-value: 0.7ANCOVA
Comparison: Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.p-value: 0.58ANCOVA
Comparison: Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.p-value: 0.29ANCOVA
Comparison: Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.p-value: 0.59ANCOVA
Comparison: Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.p-value: 0.036ANCOVA
Comparison: Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.p-value: 0.57ANCOVA
Comparison: Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.p-value: 0.49ANCOVA
Comparison: Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.p-value: 0.038ANCOVA
Comparison: Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.p-value: 0.93ANCOVA
Comparison: Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.p-value: 0.96ANCOVA
Comparison: Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.p-value: 0.72ANCOVA
Comparison: Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.p-value: 0.12ANCOVA
Comparison: Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.p-value: 0.043ANCOVA
Comparison: Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.p-value: 0.53ANCOVA
Comparison: Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.p-value: 0.75ANCOVA
Comparison: Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.p-value: 0.46ANCOVA
Comparison: Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.p-value: 0.64ANCOVA
Comparison: Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.p-value: 0.47ANCOVA
Comparison: Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.p-value: 0.75ANCOVA
Comparison: Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.p-value: 0.003ANCOVA
Comparison: Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.p-value: 0.81ANCOVA
Comparison: Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.p-value: 0.98ANCOVA
Comparison: Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.p-value: 0.87ANCOVA
Comparison: Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.p-value: 0.4ANCOVA
Comparison: Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.p-value: 0.001ANCOVA
Comparison: Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.p-value: <0.001ANCOVA
Comparison: Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.85ANCOVA
Comparison: Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.26ANCOVA
Comparison: Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.33ANCOVA
Comparison: Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.22ANCOVA
Comparison: Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.86ANCOVA
Comparison: Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.65ANCOVA
Comparison: Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.p-value: 1ANCOVA
Comparison: Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.44ANCOVA
Comparison: Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.058ANCOVA
Comparison: Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.55ANCOVA
Comparison: Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.34ANCOVA
Comparison: Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.96ANCOVA
Comparison: Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.058ANCOVA
Comparison: Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.031ANCOVA
Comparison: Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.054ANCOVA
Comparison: Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.62ANCOVA
Comparison: Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.99ANCOVA
Comparison: Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.11ANCOVA
Comparison: Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.33ANCOVA
Comparison: Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.p-value: 0.65ANCOVA
Secondary
Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12
Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.
Time frame: Baseline, Months 3, 6, 12
Population: ITT population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Change at Month 3 (n=1739,1708,1702,1746) | -23.48 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Change at Month 12 (n=1565,1522,1529,1573) | -37.49 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Change at Month 6 (n=1655,1634,1633,1681) | -32.75 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Change at Month 3 (n=1739,1708,1702,1746) | -25.28 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Change at Month 12 (n=1565,1522,1529,1573) | -39.15 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Change at Month 6 (n=1655,1634,1633,1681) | -35.20 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Change at Month 6 (n=1655,1634,1633,1681) | -35.96 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Change at Month 3 (n=1739,1708,1702,1746) | -26.18 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Change at Month 12 (n=1565,1522,1529,1573) | -41.44 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Change at Month 3 (n=1739,1708,1702,1746) | -11.37 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Change at Month 12 (n=1565,1522,1529,1573) | -21.00 Percent change |
| Placebo (Core+SE I+SE II) | Percent Change From Baseline in Osteocalcin at Month 3, 6 and 12 | Change at Month 6 (n=1655,1634,1633,1681) | -17.82 Percent change |
Comparison: Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: 0.93Ranked ANCOVA
Comparison: Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: 0.3Ranked ANCOVA
Comparison: Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Secondary
Percent Change From Baseline in Osteocalcin at Months 36 and 60
Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.
Time frame: Baseline, Months 36, 60
Population: mITT of SP1 population included all randomized participants who took at least 1 dose of test article.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Osteocalcin at Months 36 and 60 | Change at Month 36 (n=178,168,181) | -23.91 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Osteocalcin at Months 36 and 60 | Change at Month 60 (n=127, 127, 132) | -25.21 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Osteocalcin at Months 36 and 60 | Change at Month 36 (n=178,168,181) | -12.73 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Osteocalcin at Months 36 and 60 | Change at Month 60 (n=127, 127, 132) | -17.21 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Osteocalcin at Months 36 and 60 | Change at Month 36 (n=178,168,181) | -26.99 Percent change |
| Raloxifene 60 mg (Core) | Percent Change From Baseline in Osteocalcin at Months 36 and 60 | Change at Month 60 (n=127, 127, 132) | -30.41 Percent change |
Comparison: Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Comparison: Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: <0.001Ranked ANCOVA
Secondary
Percent Change From Baseline in Osteocalcin at Months 72 and 84
Osteocalcin is a biochemical marker of bone formation. Blood samples were collected to evaluate osteocalcin levels.
Time frame: Baseline, Months 72, 84
Population: mITT of SP1 population included all randomized participants who took at least 1 dose of test article. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Osteocalcin at Months 72 and 84 | Change at Month 72 (n=97,170) | -26.72 Percent change |
| Bazedoxifene 20 mg (Core+SE I) | Percent Change From Baseline in Osteocalcin at Months 72 and 84 | Change at Month 84 (n=84,147) | -29.50 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Osteocalcin at Months 72 and 84 | Change at Month 72 (n=97,170) | -33.76 Percent change |
| Bazedoxifene 40 mg (Core) | Percent Change From Baseline in Osteocalcin at Months 72 and 84 | Change at Month 84 (n=84,147) | -32.25 Percent change |
Comparison: Percent change at Month 72 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: 0.037Ranked ANCOVA
Comparison: Percent change at Month 84 in osteocalcin: P value was calculated using Ranked ANCOVA.p-value: 0.16Ranked ANCOVA
Secondary
Women's Health Questionnaire (WHQ)
WHQ is a measure of mid-aged women's emotional and physical health. Consists of 36-item assessing nine domains of physical and emotional health: Depressed mood; Somatic symptoms; Anxiety/fears; Vasomotor symptoms; Sleep problems; Sexual behavior; Menstrual symptoms; Memory/concentration; and Attractiveness. Each item scored on a 4 point scale (yes definitely, yes sometimes, not much, no not at all) reduced to binary option as 0 (no) and 1 (yes). Domain subscale score was calculated as sum of domain items score divided by number of domain items. Total score was calculated as the sum of individual domain subscale score divided by number of domains. Total score range from 0 (absent) to 1 (present), with higher scores indicating more pronounced distress and dysfunction. Baseline values at different time points were considered only for the participants who were evaluable at those time points.
Time frame: Baseline
Population: ITT population included all randomized participants who took at least 1 dose of test article;had baseline data and at least one valid assessment while on therapy. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants who were evaluable for this measure at the specified time point for each arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bazedoxifene 20 mg (Core+SE I) | Women's Health Questionnaire (WHQ) | Baseline: Month 12 (n=1490,1435,1461,1503) | 0.342 Units on a scale | Standard Deviation 0.176 |
| Bazedoxifene 20 mg (Core+SE I) | Women's Health Questionnaire (WHQ) | Baseline: Month 36 (n=1153,1138,1168,1179) | 0.333 Units on a scale | Standard Deviation 0.173 |
| Bazedoxifene 20 mg (Core+SE I) | Women's Health Questionnaire (WHQ) | Baseline: Month 24 (n=1307,1271,1311,1318) | 0.339 Units on a scale | Standard Deviation 0.175 |
| Bazedoxifene 40 mg (Core) | Women's Health Questionnaire (WHQ) | Baseline: Month 12 (n=1490,1435,1461,1503) | 0.348 Units on a scale | Standard Deviation 0.176 |
| Bazedoxifene 40 mg (Core) | Women's Health Questionnaire (WHQ) | Baseline: Month 36 (n=1153,1138,1168,1179) | 0.341 Units on a scale | Standard Deviation 0.175 |
| Bazedoxifene 40 mg (Core) | Women's Health Questionnaire (WHQ) | Baseline: Month 24 (n=1307,1271,1311,1318) | 0.343 Units on a scale | Standard Deviation 0.176 |
| Raloxifene 60 mg (Core) | Women's Health Questionnaire (WHQ) | Baseline: Month 24 (n=1307,1271,1311,1318) | 0.338 Units on a scale | Standard Deviation 0.183 |
| Raloxifene 60 mg (Core) | Women's Health Questionnaire (WHQ) | Baseline: Month 12 (n=1490,1435,1461,1503) | 0.341 Units on a scale | Standard Deviation 0.182 |
| Raloxifene 60 mg (Core) | Women's Health Questionnaire (WHQ) | Baseline: Month 36 (n=1153,1138,1168,1179) | 0.341 Units on a scale | Standard Deviation 0.182 |
| Placebo (Core+SE I+SE II) | Women's Health Questionnaire (WHQ) | Baseline: Month 12 (n=1490,1435,1461,1503) | 0.343 Units on a scale | Standard Deviation 0.182 |
| Placebo (Core+SE I+SE II) | Women's Health Questionnaire (WHQ) | Baseline: Month 36 (n=1153,1138,1168,1179) | 0.339 Units on a scale | Standard Deviation 0.18 |
| Placebo (Core+SE I+SE II) | Women's Health Questionnaire (WHQ) | Baseline: Month 24 (n=1307,1271,1311,1318) | 0.343 Units on a scale | Standard Deviation 0.181 |