Osteoporosis, Postmenopausal
Conditions
Keywords
denosumab, Republic of Korea, dual energy x-ray absorptiometry
Brief summary
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.
Interventions
DRUGdenosumab
double-blind phase: 60mg subcutaneous injection, single dose
DRUGplacebo
double-blind phase: placebo subcutaneous injection, single dose
DRUGopen-label denosumab
open-label phase: 60mg subcutaneous injection, single dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Ambulatory Korean postmenopausal women with osteoporosis * greater than 5 years postmenopausal * aged 60 to 90 years old * absolute bone mineral density value consistent with a T-score less than -2.5 and greater than or equal to - 4.0 at the either the lumbar spine or total hip, as measured by dual energy x-ray absorptiometry. Subjects with a T-score less than -4.0 are at very high risk for fracture and will be excluded.
Exclusion criteria
* previous or current metabolic bone disease, Paget's or Cushing's disease, or hyperprolactinemia * current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable thyroid replacement therapy and TSH level meets criteria * rheumatoid arthritis * cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal * medications used to treat osteoporosis, defined for type and duration of use, and including IV and oral bisphosphonates * medications that affect bone metabolism including parathyroid hormone or derivatives; anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol or vitamin D derivatives; other bone active drugs including anticonvulsives (but not benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and gonadotropin-releasing hormone agonists * malignancy within 5 years except certain resected types * malabsorption syndrome or gastrointestinal disorders associated with malabsorption * abnormal calcium level * vitamin D deficiency * any laboratory abnormality that will prevent the subject from completing the study or interfere with interpretation of study results * severe renal impairment or on dialysis * impaired immune system or subject is taking immunosuppressants * oral or dental conditions including current or past history of osteomyelitis or osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery; planned invasive dental procedure; un-healed dental or oral surgery * any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures * any physical or psychiatric disorder that will prevent the subject from completing the study or interferes with study results * known to have tested positive for HIV * less than two lumbar vertebrae evaluable for DXA measurements * height, weight, or girth that may preclude accurate DXA measurements * drug or alcohol abuse within 12 months that interferes with understanding or completing the study * known sensitivity to mammalian cell-derived drug products * use of an investigational drug or device within 30 days of enrollment or currently receiving other investigational agent(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Baseline and Month 6 | Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline \* 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Baseline, Month 1 and Month 6 | Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1/6 - measure at Baseline) divided by the measure at Baseline \* 100. |
| Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | Baseline, Months 1, 3 and 6 | Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline \* 100. |
| Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) | From Baseline up to Month 6 | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. |
| Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6 | Baseline and Month 6 | Change from Baseline was calculated as the Month 6 value minus the Baseline value. |
| Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6 | Baseline and Month 6 | Change from Baseline was calculated as the Month 6 value minus the Baseline value. |
| Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Baseline and Month 6 | Change from Baseline was calculated as the Month 6 value minus the Baseline value. |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Baseline and Month 6 | Change from Baseline was calculated as the Month 6 value minus the Baseline value. |
| Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6 | Baseline and Month 6 | Change from Baseline was calculated as the Month 6 value minus the Baseline value. |
| Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1 | Baseline and Month 1 | Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 - measure at Baseline) divided by the measure at Baseline \* 100. |
| Change From Baseline in Hematocrit at Month 6 | Baseline and Month 6 | Change from Baseline was calculated as the Month 6 value minus the Baseline value. |
| Change From Baseline in Mean Corpuscle Hemoglobin at Month 6 | Baseline and Month 6 | Change from Baseline was calculated as the Month 6 value minus the Baseline value. |
| Change From Baseline in Mean Corpuscular Volume at Month 6 | Baseline and Month 6 | Change from Baseline was calculated as the Month 6 value minus the Baseline value. |
| Change From Baseline in Red Blood Cell Count at Month 6 | Baseline and Month 6 | Change from Baseline was calculated as the Month 6 value minus the Baseline value. |
| Change From Baseline in Red Cell Distribution Width at Month 6 | Baseline and Month 6 | Change from Baseline was calculated as the Month 6 value minus the Baseline value. |
| Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6 | Baseline and Month 6 | Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (\<50 or \>120 Bits Per Minutes \[bpm\]), Systolic Blood Pressure (\>170 Millimeters of Mercury \[mmHg\] or \<100 mmHg) and Heart rate (\>110 mmHg or \<50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value. |
| Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab | Month 6 | Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized. |
| Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Baseline and Month 6 | Change from Baseline was calculated as the Month 6 value minus the Baseline value. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab | Baseline and Month 12 | Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline \* 100. |
| Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12 | Month 12 | Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 12 was summarized. |
| Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo | Month 6 and Month 12 | Mean percent change from Month 6 in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 \* 100. |
| Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab | Baseline and Month 12 | Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline \* 100. |
| Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo | Month 6 and Month 12 | Mean percent change from Month 6 in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 \* 100. |
| Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab | Baseline and Month 12 | Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline \* 100. |
| Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo | Month 6 and Month 12 | Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by measure at Month 6 \* 100. |
| Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Baseline and Month 12 | Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (\<50 or \>120 Bits Per Minutes \[bpm\]), Systolic Blood Pressure (\>170 Millimeters of Mercury \[mmHg\] or \<100 mmHg) and Heart rate (\>110 mmHg or \<50 mmHg) are summarized. Change from Baseline was calculated as the Month 12 value minus the Baseline value. |
| Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase | From Month 6 to Month 12 | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. |
| Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12 | Baseline and Month 12 | Change from Baseline was calculated as the Month 12 value minus the Baseline value. |
| Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12 | Baseline and Month 12 | Change from Baseline was calculated as the Month 12 value minus the Baseline value. |
| Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Baseline and Month 12 | Change from Baseline was calculated as the Month 12 value minus the Baseline value. |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Baseline and Month 12 | Change from Baseline was calculated as the Month 12 value minus the Baseline value. |
| Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12 | Baseline and Month 12 | Change from Baseline was calculated as the Month 12 value minus the Baseline value. |
| Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Baseline and Month 12 | Change from Baseline was calculated as the Month 12 value minus the Baseline value. |
| Change From Baseline in Hematocrit at Month 12 | Baseline and Month 12 | Change from Baseline was calculated as the Month 12 value minus the Baseline value. |
| Change From Baseline in Mean Corpuscle Hemoglobin at Month 12 | Baseline and Month 12 | Change from Baseline was calculated as the Month 12 value minus the Baseline value. |
| Change From Baseline in Red Blood Cell Count at Month 12 | Baseline and Month 12 | Change from Baseline was calculated as the Month 12 value minus the Baseline value. |
| Change From Baseline in Red Cell Distribution Width at Month 12 | Baseline and Month 12 | Change from Baseline was calculated as the Month 12 value minus the Baseline value. |
Countries
South Korea
Participant flow
Pre-assignment details
This study consisted of a screening phase of up to 2.5 months, a six-month Double-Blind Treatment Phase and a six-month Open-Label Extension Phase. 371 participants (par.) were screened, 135 par. entered the Double-Blind Treatment Phase, and 123 par. continued into the Open-Label Extension Phase.
Participants by arm
| Arm | Count |
|---|---|
| Denosumab 60 mg Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units \[IU\]). | 69 |
| Placebo Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). | 66 |
| Total | 135 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-Blind Phase | Continuation Criteria Not Met | 1 | 0 | 0 | 0 |
| Double-Blind Phase | Protocol Violation | 2 | 1 | 0 | 0 |
| Double-Blind Phase | Withdrawal by Subject | 6 | 2 | 0 | 0 |
| Open-Label Phase | Adverse Event | 0 | 0 | 0 | 1 |
| Open-Label Phase | Protocol Violation | 0 | 0 | 0 | 1 |
| Open-Label Phase | Withdrawal by Subject | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Denosumab 60 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 67.0 Years STANDARD_DEVIATION 4.86 | 66.0 Years STANDARD_DEVIATION 4.77 | 66.5 Years STANDARD_DEVIATION 4.83 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 69 Participants | 66 Participants | 135 Participants |
| Sex: Female, Male Female | 69 Participants | 66 Participants | 135 Participants |
| Sex: Female, Male Male | 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 | 13 / 69 | 11 / 66 | 12 / 60 | 7 / 63 |
| serious Total, serious adverse events | 7 / 69 | 2 / 66 | 1 / 60 | 3 / 63 |
Outcome results
Primary
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline \* 100.
Time frame: Baseline and Month 6
Population: Intent-to-Treat Efficacy (ITTE) Population: all participants who received one dose of study medication, and had a Baseline measure and at least one post-Baseline efficacy measure during the Double-Blind Treatment Phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6 | 4.10 Percent change | Standard Error 0.407 |
| Placebo | Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6 | 0.89 Percent change | Standard Error 0.413 |
p-value: <0.000195% CI: [2.06, 4.36]ANCOVA
Secondary
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time frame: Baseline and Month 6
Population: ITT Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6 | Albumin/globulin ratio, n=60, 63 | 0.020 Ratio | Standard Deviation 0.1424 |
| Denosumab 60 mg | Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6 | BUN/creatinine ratio, n=60, 63 | -7.917 Ratio | Standard Deviation 25.2917 |
| Placebo | Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6 | Albumin/globulin ratio, n=60, 63 | 0.052 Ratio | Standard Deviation 0.139 |
| Placebo | Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6 | BUN/creatinine ratio, n=60, 63 | -4.063 Ratio | Standard Deviation 27.3436 |
Secondary
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time frame: Baseline and Month 6
Population: ITT Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6 | Albumin, n=60,63 | 0.217 Grams (G)/Liter (L) | Standard Deviation 1.8964 |
| Denosumab 60 mg | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6 | Hemoglobin, n=59, 63 | 1.153 Grams (G)/Liter (L) | Standard Deviation 5.8274 |
| Denosumab 60 mg | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6 | Mean corpuscle hemoglobin concentration, n=59, 63 | -5.186 Grams (G)/Liter (L) | Standard Deviation 9.9264 |
| Denosumab 60 mg | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6 | Total protein, n=60, 63 | -0.050 Grams (G)/Liter (L) | Standard Deviation 2.9939 |
| Placebo | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6 | Total protein, n=60, 63 | -0.127 Grams (G)/Liter (L) | Standard Deviation 3.3864 |
| Placebo | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6 | Albumin, n=60,63 | 0.365 Grams (G)/Liter (L) | Standard Deviation 2.2598 |
| Placebo | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6 | Mean corpuscle hemoglobin concentration, n=59, 63 | -6.857 Grams (G)/Liter (L) | Standard Deviation 9.4593 |
| Placebo | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6 | Hemoglobin, n=59, 63 | 1.778 Grams (G)/Liter (L) | Standard Deviation 5.6894 |
Secondary
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time frame: Baseline and Month 6
Population: ITT Population. Only participants at the specified time points were analyzed. .
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Alkaline phosphatase, n=60, 63 | -24.283 Internationational Units(IU)/Liter (L) | Standard Deviation 15.9513 |
| Denosumab 60 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Alanine amino transferase, n=60, 63 | 2.117 Internationational Units(IU)/Liter (L) | Standard Deviation 6.4047 |
| Denosumab 60 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Aspartate amino transferase, n=59, 63 | 1.034 Internationational Units(IU)/Liter (L) | Standard Deviation 4.4527 |
| Denosumab 60 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Creatine kinase, n=60, 63 | 7.617 Internationational Units(IU)/Liter (L) | Standard Deviation 51.6658 |
| Denosumab 60 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Gamma glutamyl transferase, n=60, 63 | -0.133 Internationational Units(IU)/Liter (L) | Standard Deviation 8.4381 |
| Denosumab 60 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Lactate dehydraogenase, n=59, 63 | 6.119 Internationational Units(IU)/Liter (L) | Standard Deviation 18.1156 |
| Placebo | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Gamma glutamyl transferase, n=60, 63 | -2.143 Internationational Units(IU)/Liter (L) | Standard Deviation 7.9532 |
| Placebo | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Alkaline phosphatase, n=60, 63 | -8.222 Internationational Units(IU)/Liter (L) | Standard Deviation 11.2127 |
| Placebo | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Creatine kinase, n=60, 63 | 3.905 Internationational Units(IU)/Liter (L) | Standard Deviation 31.2052 |
| Placebo | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Alanine amino transferase, n=60, 63 | -0.397 Internationational Units(IU)/Liter (L) | Standard Deviation 8.8035 |
| Placebo | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Lactate dehydraogenase, n=59, 63 | 3.889 Internationational Units(IU)/Liter (L) | Standard Deviation 20.4979 |
| Placebo | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6 | Aspartate amino transferase, n=59, 63 | -0.032 Internationational Units(IU)/Liter (L) | Standard Deviation 7.4962 |
Secondary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time frame: Baseline and Month 6
Population: ITT Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Basophils, n=58, 63 | -0.003 10^9 cells per liter (GI/L) | Standard Deviation 0.0131 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Eosinophils, n=58, 63 | -0.019 10^9 cells per liter (GI/L) | Standard Deviation 0.1254 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Lymphocytes, n=58, 63 | -0.047 10^9 cells per liter (GI/L) | Standard Deviation 0.4096 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Monocytes, n=58, 63 | -0.033 10^9 cells per liter (GI/L) | Standard Deviation 0.1094 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Segmented neutrophils, n=58, 63 | 0.114 10^9 cells per liter (GI/L) | Standard Deviation 1.3382 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Total neutrophils, n=58, 63 | 0.114 10^9 cells per liter (GI/L) | Standard Deviation 1.3382 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Platelet count, n=58, 63 | 1.621 10^9 cells per liter (GI/L) | Standard Deviation 31.7881 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | White blood cell count, n=58, 63 | 0.014 10^9 cells per liter (GI/L) | Standard Deviation 1.4026 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | White blood cell count, n=58, 63 | -0.517 10^9 cells per liter (GI/L) | Standard Deviation 1.2003 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Basophils, n=58, 63 | -0.006 10^9 cells per liter (GI/L) | Standard Deviation 0.0165 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Segmented neutrophils, n=58, 63 | -0.213 10^9 cells per liter (GI/L) | Standard Deviation 1.0934 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Eosinophils, n=58, 63 | -0.033 10^9 cells per liter (GI/L) | Standard Deviation 0.1309 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Platelet count, n=58, 63 | -6.190 10^9 cells per liter (GI/L) | Standard Deviation 35.7874 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Lymphocytes, n=58, 63 | -0.206 10^9 cells per liter (GI/L) | Standard Deviation 0.593 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Total neutrophils, n=58, 63 | -0.213 10^9 cells per liter (GI/L) | Standard Deviation 1.0934 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6 | Monocytes, n=58, 63 | -0.059 10^9 cells per liter (GI/L) | Standard Deviation 0.1324 |
Secondary
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time frame: Baseline and Month 6
Population: ITT Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Glucose, n=60, 63 | -0.873 Millimole/Liter (MMOL/L) | Standard Deviation 2.5458 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Sodium, n=60, 63 | -0.400 Millimole/Liter (MMOL/L) | Standard Deviation 2.1249 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Phosphorus inorganic, n=60, 63 | -0.072 Millimole/Liter (MMOL/L) | Standard Deviation 0.1505 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Chloride, n=60, 63 | -0.200 Millimole/Liter (MMOL/L) | Standard Deviation 2.2981 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Triglycerides, n=60, 63 | -0.166 Millimole/Liter (MMOL/L) | Standard Deviation 0.7155 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Potassium, n=59, 63 | 0.000 Millimole/Liter (MMOL/L) | Standard Deviation 0.39 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Urea/BUN, n=60, 63 | -0.258 Millimole/Liter (MMOL/L) | Standard Deviation 1.1878 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Calcium, n=59, 63 | -0.020 Millimole/Liter (MMOL/L) | Standard Deviation 0.089 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | VLDL cholesterol calculation, n=59, 63 | -0.098 Millimole/Liter (MMOL/L) | Standard Deviation 0.2844 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Magnesium, n=60, 63 | 0.004 Millimole/Liter (MMOL/L) | Standard Deviation 0.0585 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Calcium (corrected), n=1, 1 | 0.110 Millimole/Liter (MMOL/L) | — |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Sodium, n=60, 63 | 0.095 Millimole/Liter (MMOL/L) | Standard Deviation 1.9486 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Calcium (corrected), n=1, 1 | 0.000 Millimole/Liter (MMOL/L) | — |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Calcium, n=59, 63 | 0.002 Millimole/Liter (MMOL/L) | Standard Deviation 0.0768 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Chloride, n=60, 63 | 0.444 Millimole/Liter (MMOL/L) | Standard Deviation 2.3264 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Glucose, n=60, 63 | -0.567 Millimole/Liter (MMOL/L) | Standard Deviation 1.2118 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Potassium, n=59, 63 | 0.060 Millimole/Liter (MMOL/L) | Standard Deviation 0.3476 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Magnesium, n=60, 63 | 0.009 Millimole/Liter (MMOL/L) | Standard Deviation 0.0462 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Phosphorus inorganic, n=60, 63 | -0.063 Millimole/Liter (MMOL/L) | Standard Deviation 0.1695 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Triglycerides, n=60, 63 | -0.156 Millimole/Liter (MMOL/L) | Standard Deviation 0.6119 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | Urea/BUN, n=60, 63 | -0.119 Millimole/Liter (MMOL/L) | Standard Deviation 1.4134 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6 | VLDL cholesterol calculation, n=59, 63 | -0.072 Millimole/Liter (MMOL/L) | Standard Deviation 0.281 |
Secondary
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time frame: Baseline and Month 6
Population: ITT Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6 | Indirect bilirubin, n=60, 63 | 1.567 Micromole/liter (UMOL/L) | Standard Deviation 3.4757 |
| Denosumab 60 mg | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6 | Creatinine, n=60, 63 | 2.037 Micromole/liter (UMOL/L) | Standard Deviation 6.4916 |
| Denosumab 60 mg | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6 | Total bilirubin, n=60, 63 | 1.867 Micromole/liter (UMOL/L) | Standard Deviation 3.8947 |
| Denosumab 60 mg | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6 | Uric acid, n=60, 63 | 11.500 Micromole/liter (UMOL/L) | Standard Deviation 38.9622 |
| Denosumab 60 mg | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6 | Direct bilirubin, n=60, 63 | 0.300 Micromole/liter (UMOL/L) | Standard Deviation 1.0301 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6 | Uric acid, n=60, 63 | 0.159 Micromole/liter (UMOL/L) | Standard Deviation 40.9757 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6 | Direct bilirubin, n=60, 63 | 0.222 Micromole/liter (UMOL/L) | Standard Deviation 1.1974 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6 | Indirect bilirubin, n=60, 63 | 0.508 Micromole/liter (UMOL/L) | Standard Deviation 3.5372 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6 | Total bilirubin, n=60, 63 | 0.730 Micromole/liter (UMOL/L) | Standard Deviation 3.8404 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6 | Creatinine, n=60, 63 | 0.940 Micromole/liter (UMOL/L) | Standard Deviation 5.1644 |
Secondary
Change From Baseline in Hematocrit at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time frame: Baseline and Month 6
Population: ITT Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Hematocrit at Month 6 | 0.009 Proportion of RBCs in blood | Standard Deviation 0.0196 |
| Placebo | Change From Baseline in Hematocrit at Month 6 | 0.013 Proportion of RBCs in blood | Standard Deviation 0.0196 |
Secondary
Change From Baseline in Mean Corpuscle Hemoglobin at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time frame: Baseline and Month 6
Population: ITT Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Mean Corpuscle Hemoglobin at Month 6 | 0.068 Picograms (PG)/cell | Standard Deviation 0.7111 |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin at Month 6 | 0.146 Picograms (PG)/cell | Standard Deviation 0.6696 |
Secondary
Change From Baseline in Mean Corpuscular Volume at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time frame: Baseline and Month 6
Population: ITT Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Mean Corpuscular Volume at Month 6 | 1.695 Femtoliters (FL) | Standard Deviation 2.5 |
| Placebo | Change From Baseline in Mean Corpuscular Volume at Month 6 | 2.397 Femtoliters (FL) | Standard Deviation 2.6368 |
Secondary
Change From Baseline in Red Blood Cell Count at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time frame: Baseline and Month 6
Population: ITT Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Red Blood Cell Count at Month 6 | 0.025 10^12 cells per liter (TI/L) | Standard Deviation 0.1844 |
| Placebo | Change From Baseline in Red Blood Cell Count at Month 6 | 0.037 10^12 cells per liter (TI/L) | Standard Deviation 0.192 |
Secondary
Change From Baseline in Red Cell Distribution Width at Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time frame: Baseline and Month 6
Population: ITT Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Red Cell Distribution Width at Month 6 | 0.475 percentage (%) of mean RBC volume | Standard Deviation 1.0256 |
| Placebo | Change From Baseline in Red Cell Distribution Width at Month 6 | 0.556 percentage (%) of mean RBC volume | Standard Deviation 0.9242 |
Secondary
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 - measure at Baseline) divided by the measure at Baseline \* 100.
Time frame: Baseline and Month 1
Population: ITTE Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1 | 1.35 Percent change | Standard Error 0.375 |
| Placebo | Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1 | 0.62 Percent change | Standard Error 0.38 |
Secondary
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1/6 - measure at Baseline) divided by the measure at Baseline \* 100.
Time frame: Baseline, Month 1 and Month 6
Population: ITTE Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Total hip, Month 1, n=67, 63 | 0.74 Percent change | Standard Error 0.238 |
| Denosumab 60 mg | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Total hip, Month 6, n=69, 64 | 2.23 Percent change | Standard Error 0.245 |
| Denosumab 60 mg | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Femoral neck, Month 1, n=67, 63 | 1.30 Percent change | Standard Error 0.344 |
| Denosumab 60 mg | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Fermoral neck, Month 6, n=69, 64 | 2.23 Percent change | Standard Error 0.33 |
| Denosumab 60 mg | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Trochanter, Month 1, n=67, 63 | 0.82 Percent change | Standard Error 0.38 |
| Denosumab 60 mg | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Trochanter, Month n =69, 64 | 2.66 Percent change | Standard Error 0.418 |
| Placebo | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Trochanter, Month 1, n=67, 63 | 0.39 Percent change | Standard Error 0.392 |
| Placebo | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Total hip, Month 1, n=67, 63 | 0.05 Percent change | Standard Error 0.245 |
| Placebo | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Fermoral neck, Month 6, n=69, 64 | 0.84 Percent change | Standard Error 0.343 |
| Placebo | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Total hip, Month 6, n=69, 64 | 0.57 Percent change | Standard Error 0.254 |
| Placebo | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Trochanter, Month n =69, 64 | 0.67 Percent change | Standard Error 0.434 |
| Placebo | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6 | Femoral neck, Month 1, n=67, 63 | -0.04 Percent change | Standard Error 0.354 |
Secondary
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline \* 100.
Time frame: Baseline, Months 1, 3 and 6
Population: ITTE Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Denosumab 60 mg | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | s-CTx, Month 1, n=69, 66 | -80.72 Percent change |
| Denosumab 60 mg | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | s-CTx, Month 3, n=68, 65 | -82.23 Percent change |
| Denosumab 60 mg | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | s-CTx, Month 6, n=60, 63 | -74.32 Percent change |
| Denosumab 60 mg | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | s-PINP, Month 1, n=69, 66 | -18.75 Percent change |
| Denosumab 60 mg | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | s-PINP, Month 3, n=68, 65 | -77.1 Percent change |
| Denosumab 60 mg | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | s-PINP, Month 6, n=60, 63 | -76.18 Percent change |
| Placebo | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | s-PINP, Month 3, n=68, 65 | -21.57 Percent change |
| Placebo | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | s-CTx, Month 1, n=69, 66 | -14.48 Percent change |
| Placebo | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | s-PINP, Month 1, n=69, 66 | -4.65 Percent change |
| Placebo | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | s-CTx, Month 3, n=68, 65 | -27.49 Percent change |
| Placebo | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | s-PINP, Month 6, n=60, 63 | -21.05 Percent change |
| Placebo | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6 | s-CTx, Month 6, n=60, 63 | -21.21 Percent change |
Secondary
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6
Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (\<50 or \>120 Bits Per Minutes \[bpm\]), Systolic Blood Pressure (\>170 Millimeters of Mercury \[mmHg\] or \<100 mmHg) and Heart rate (\>110 mmHg or \<50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Time frame: Baseline and Month 6
Population: ITT Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Denosumab 60 mg | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6 | Systolic blood pressure, High, n=60, 63 | 1 Participants |
| Denosumab 60 mg | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6 | Heart rate, High, n=60, 63 | 0 Participants |
| Denosumab 60 mg | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6 | Systolic blood pressure, Low, n=60, 63 | 1 Participants |
| Denosumab 60 mg | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6 | Heart rate, Low, n=60, 63 | 0 Participants |
| Denosumab 60 mg | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6 | Diastolic blood pressure, Low, n=60, 63 | 0 Participants |
| Placebo | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6 | Heart rate, Low, n=60, 63 | 0 Participants |
| Placebo | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6 | Diastolic blood pressure, Low, n=60, 63 | 2 Participants |
| Placebo | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6 | Systolic blood pressure, High, n=60, 63 | 2 Participants |
| Placebo | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6 | Systolic blood pressure, Low, n=60, 63 | 1 Participants |
| Placebo | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6 | Heart rate, High, n=60, 63 | 0 Participants |
Secondary
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Time frame: From Baseline up to Month 6
Population: Intent-to-Treat (ITT) Population: all participants who received one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Denosumab 60 mg | Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) | Any AE | 38 Participants |
| Denosumab 60 mg | Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) | Any SAE | 7 Participants |
| Placebo | Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) | Any AE | 32 Participants |
| Placebo | Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) | Any SAE | 2 Participants |
Secondary
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab
Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.
Time frame: Month 6
Population: ITT Population. Only participants at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Denosumab 60 mg | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab | Neutralizing antibodies, Positive, n=0, 0 | NA Participants |
| Denosumab 60 mg | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab | Neutralizing antibodies, Negative, n=0, 0 | NA Participants |
| Denosumab 60 mg | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab | Binding antibodies, Positive, n=60, 63 | 0 Participants |
| Denosumab 60 mg | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab | Binding antibodies, Negative, n=60, 63 | 60 Participants |
| Placebo | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab | Binding antibodies, Negative, n=60, 63 | 63 Participants |
| Placebo | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab | Neutralizing antibodies, Positive, n=0, 0 | NA Participants |
| Placebo | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab | Binding antibodies, Positive, n=60, 63 | 0 Participants |
| Placebo | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab | Neutralizing antibodies, Negative, n=0, 0 | NA Participants |
Other Pre-specified
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time frame: Baseline and Month 12
Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12 | Albumin/globulin ratio, n=58, 60 | 0.016 Ratio | Standard Deviation 0.1473 |
| Denosumab 60 mg | Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12 | BUN/creatinine ratio, n=58, 60 | -5.776 Ratio | Standard Deviation 24.4297 |
| Placebo | Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12 | Albumin/globulin ratio, n=58, 60 | 0.032 Ratio | Standard Deviation 0.1621 |
| Placebo | Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12 | BUN/creatinine ratio, n=58, 60 | 2.500 Ratio | Standard Deviation 27.7962 |
Other Pre-specified
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time frame: Baseline and Month 12
Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12 | Albumin, n=58, 60 | 0.293 Grams (G)/Liter (L) | Standard Deviation 2.111 |
| Denosumab 60 mg | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12 | Hemoglobin, n=56, 60 | 1.411 Grams (G)/Liter (L) | Standard Deviation 5.7833 |
| Denosumab 60 mg | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12 | Mean corpuscle hemoglobin concentration, n=56, 60 | -5.679 Grams (G)/Liter (L) | Standard Deviation 6.6143 |
| Denosumab 60 mg | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12 | Total protein, n=58, 60 | 0.224 Grams (G)/Liter (L) | Standard Deviation 3.4946 |
| Placebo | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12 | Total protein, n=58, 60 | 0.267 Grams (G)/Liter (L) | Standard Deviation 2.8216 |
| Placebo | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12 | Albumin, n=58, 60 | 0.450 Grams (G)/Liter (L) | Standard Deviation 1.9866 |
| Placebo | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12 | Mean corpuscle hemoglobin concentration, n=56, 60 | -6.650 Grams (G)/Liter (L) | Standard Deviation 7.7587 |
| Placebo | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12 | Hemoglobin, n=56, 60 | 2.033 Grams (G)/Liter (L) | Standard Deviation 6.0084 |
Other Pre-specified
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time frame: Baseline and Month 12
Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Alkaline phosphatase, n=58, 60 | -25.603 Internationational Units(IU)/Liter (L) | Standard Deviation 14.478 |
| Denosumab 60 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Alanine amino transferase, n=58, 60 | 1.810 Internationational Units(IU)/Liter (L) | Standard Deviation 7.9922 |
| Denosumab 60 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Aspartate amino transferase, n=58, 60 | 0.879 Internationational Units(IU)/Liter (L) | Standard Deviation 6.4293 |
| Denosumab 60 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Creatine kinase, n=58, 60 | -4.534 Internationational Units(IU)/Liter (L) | Standard Deviation 44.069 |
| Denosumab 60 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Gamma glutamyl transferase, n=58, 60 | 0.4823 Internationational Units(IU)/Liter (L) | Standard Deviation 6.9541 |
| Denosumab 60 mg | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Lactate dehydraogenase, n=58, 60 | -0.552 Internationational Units(IU)/Liter (L) | Standard Deviation 19.2237 |
| Placebo | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Gamma glutamyl transferase, n=58, 60 | -0.600 Internationational Units(IU)/Liter (L) | Standard Deviation 9.4961 |
| Placebo | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Alkaline phosphatase, n=58, 60 | -23.767 Internationational Units(IU)/Liter (L) | Standard Deviation 15.757 |
| Placebo | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Creatine kinase, n=58, 60 | 4.500 Internationational Units(IU)/Liter (L) | Standard Deviation 52.0731 |
| Placebo | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Alanine amino transferase, n=58, 60 | -0.150 Internationational Units(IU)/Liter (L) | Standard Deviation 8.9288 |
| Placebo | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Lactate dehydraogenase, n=58, 60 | -1.217 Internationational Units(IU)/Liter (L) | Standard Deviation 24.7243 |
| Placebo | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12 | Aspartate amino transferase, n=58, 60 | -0.467 Internationational Units(IU)/Liter (L) | Standard Deviation 6.2666 |
Other Pre-specified
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time frame: Baseline and Month 12
Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Basophils, n=54, 59 | -0.004 10^9 cells per liter (GI/L) | Standard Deviation 0.0164 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Eosinophils, n=54, 59 | 0.024 10^9 cells per liter (GI/L) | Standard Deviation 0.1489 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Lymphocytes, n=54, 59 | 0.098 10^9 cells per liter (GI/L) | Standard Deviation 0.4436 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Monocytes, n=54, 59 | -0.009 10^9 cells per liter (GI/L) | Standard Deviation 0.1053 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Segmented neutrophils, n=54, 59 | 0.014 10^9 cells per liter (GI/L) | Standard Deviation 1.1748 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Total neutrophils, n=54, 59 | 0.014 10^9 cells per liter (GI/L) | Standard Deviation 1.1748 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Platelet count, n=55, 60 | -4.018 10^9 cells per liter (GI/L) | Standard Deviation 34.8215 |
| Denosumab 60 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | White blood cell count, n=54, 59 | 0.122 10^9 cells per liter (GI/L) | Standard Deviation 1.1618 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | White blood cell count, n=54, 59 | -0.369 10^9 cells per liter (GI/L) | Standard Deviation 1.3903 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Basophils, n=54, 59 | -0.002 10^9 cells per liter (GI/L) | Standard Deviation 0.0148 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Segmented neutrophils, n=54, 59 | -0.259 10^9 cells per liter (GI/L) | Standard Deviation 1.2035 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Eosinophils, n=54, 59 | 0.019 10^9 cells per liter (GI/L) | Standard Deviation 0.186 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Platelet count, n=55, 60 | -4.233 10^9 cells per liter (GI/L) | Standard Deviation 37.7913 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Lymphocytes, n=54, 59 | -0.089 10^9 cells per liter (GI/L) | Standard Deviation 0.5599 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Total neutrophils, n=54, 59 | -0.259 10^9 cells per liter (GI/L) | Standard Deviation 1.2035 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12 | Monocytes, n=54, 59 | -0.039 10^9 cells per liter (GI/L) | Standard Deviation 0.1443 |
Other Pre-specified
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time frame: Baseline and Month 12
Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Calcium, n=58, 60 | -0.031 Millimole/Liter (MMOL/L) | Standard Deviation 0.0944 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Chloride, n=58, 60 | 0.328 Millimole/Liter (MMOL/L) | Standard Deviation 2.5573 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Glucose, n=58, 60 | -0.760 Millimole/Liter (MMOL/L) | Standard Deviation 2.9331 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Potassium, n=58, 60 | 0.047 Millimole/Liter (MMOL/L) | Standard Deviation 0.4398 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Magnesium, n=58, 60 | 0.009 Millimole/Liter (MMOL/L) | Standard Deviation 0.0679 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Sodium, n=58, 60 | -0.172 Millimole/Liter (MMOL/L) | Standard Deviation 2.1532 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Phosphorus inorganic, n=58, 60 | -0.153 Millimole/Liter (MMOL/L) | Standard Deviation 0.153 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Triglycerides, n=58, 60 | -0.144 Millimole/Liter (MMOL/L) | Standard Deviation 0.7716 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Urea/BUN, n=58, 60 | -0.233 Millimole/Liter (MMOL/L) | Standard Deviation 1.2183 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | VLDL cholesterol calculation, n=58, 59 | -0.066 Millimole/Liter (MMOL/L) | Standard Deviation 0.3539 |
| Denosumab 60 mg | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Calcium (corrected), n=0, 0 | NA Millimole/Liter (MMOL/L) | — |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Triglycerides, n=58, 60 | -0.033 Millimole/Liter (MMOL/L) | Standard Deviation 0.8449 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Calcium (corrected), n=0, 0 | NA Millimole/Liter (MMOL/L) | — |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Calcium, n=58, 60 | -0.004 Millimole/Liter (MMOL/L) | Standard Deviation 0.0904 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Sodium, n=58, 60 | 0.067 Millimole/Liter (MMOL/L) | Standard Deviation 2.2986 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Chloride, n=58, 60 | 0.300 Millimole/Liter (MMOL/L) | Standard Deviation 2.4446 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | VLDL cholesterol calculation, n=58, 59 | -0.044 Millimole/Liter (MMOL/L) | Standard Deviation 0.3234 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Glucose, n=58, 60 | -0.500 Millimole/Liter (MMOL/L) | Standard Deviation 1.2985 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Phosphorus inorganic, n=58, 60 | -0.094 Millimole/Liter (MMOL/L) | Standard Deviation 0.1981 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Potassium, n=58, 60 | 0.045 Millimole/Liter (MMOL/L) | Standard Deviation 0.3078 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Urea/BUN, n=58, 60 | 0.158 Millimole/Liter (MMOL/L) | Standard Deviation 1.5771 |
| Placebo | Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12 | Magnesium, n=58, 60 | 0.004 Millimole/Liter (MMOL/L) | Standard Deviation 0.0514 |
Other Pre-specified
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time frame: Baseline and Month 12
Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12 | Indirect bilirubin, n=58, 60 | 1.034 Micromole/liter (UMOL/L) | Standard Deviation 4.0391 |
| Denosumab 60 mg | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12 | Creatinine, n=58, 60 | 0.948 Micromole/liter (UMOL/L) | Standard Deviation 5.1157 |
| Denosumab 60 mg | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12 | Total bilirubin, n=58, 60 | 1.276 Micromole/liter (UMOL/L) | Standard Deviation 4.6596 |
| Denosumab 60 mg | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12 | Uric acid, n=58, 60 | 4.483 Micromole/liter (UMOL/L) | Standard Deviation 41.387 |
| Denosumab 60 mg | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12 | Direct bilirubin, n=58, 60 | 0.241 Micromole/liter (UMOL/L) | Standard Deviation 1.3548 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12 | Uric acid, n=58, 60 | 2.000 Micromole/liter (UMOL/L) | Standard Deviation 44.0647 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12 | Direct bilirubin, n=58, 60 | 0.100 Micromole/liter (UMOL/L) | Standard Deviation 1.298 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12 | Indirect bilirubin, n=58, 60 | 0.800 Micromole/liter (UMOL/L) | Standard Deviation 3.3385 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12 | Total bilirubin, n=58, 60 | 0.900 Micromole/liter (UMOL/L) | Standard Deviation 3.5401 |
| Placebo | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12 | Creatinine, n=58, 60 | -0.015 Micromole/liter (UMOL/L) | Standard Deviation 4.6216 |
Other Pre-specified
Change From Baseline in Hematocrit at Month 12
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time frame: Baseline and Month 12
Population: ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Hematocrit at Month 12 | 0.010 Proportion of RBCs in blood | Standard Deviation 0.0182 |
| Placebo | Change From Baseline in Hematocrit at Month 12 | 0.014 Proportion of RBCs in blood | Standard Deviation 0.0185 |
Other Pre-specified
Change From Baseline in Mean Corpuscle Hemoglobin at Month 12
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time frame: Baseline and Month 12
Population: ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Mean Corpuscle Hemoglobin at Month 12 | -0.304 Picograms (PG)/cell) | Standard Deviation 0.7632 |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin at Month 12 | -0.310 Picograms (PG)/cell) | Standard Deviation 0.5058 |
Other Pre-specified
Change From Baseline in Red Blood Cell Count at Month 12
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time frame: Baseline and Month 12
Population: ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Red Blood Cell Count at Month 12 | 0.086 10^12 cells per liter (TI/L) | Standard Deviation 0.1634 |
| Placebo | Change From Baseline in Red Blood Cell Count at Month 12 | 0.103 10^12 cells per liter (TI/L) | Standard Deviation 0.1904 |
Other Pre-specified
Change From Baseline in Red Cell Distribution Width at Month 12
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time frame: Baseline and Month 12
Population: ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Change From Baseline in Red Cell Distribution Width at Month 12 | 0.007 percentage (%) of mean RBC volume | Standard Deviation 0.7897 |
| Placebo | Change From Baseline in Red Cell Distribution Width at Month 12 | 0.203 percentage (%) of mean RBC volume | Standard Deviation 0.8718 |
Other Pre-specified
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline \* 100.
Time frame: Baseline and Month 12
Population: Intent-to-Treat Open-Label (ITT-OL) Population: all participants from the ITT population in the Double-Blind Phase who continued into the Open-Label Extension Phase of the study and received denosumab at Month 6. Ony those participants with a value at Baseline and Month 12 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab | 5.62 Percent change | Standard Error 3.776 |
Other Pre-specified
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab
Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline \* 100.
Time frame: Baseline and Month 12
Population: ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab | Total hip | 3.07 Percent change | Standard Error 2.476 |
| Denosumab 60 mg | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab | Femoral neck | 3.39 Percent change | Standard Error 3.158 |
| Denosumab 60 mg | Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab | Trochanter | 3.39 Percent change | Standard Error 4.653 |
Other Pre-specified
Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo
Mean percent change from Month 6 in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 \* 100.
Time frame: Month 6 and Month 12
Population: ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denosumab 60 mg | Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo | 2.67 Percent change | Standard Error 3.44 |
Other Pre-specified
Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo
Mean percent change from Month 6 in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 \* 100.
Time frame: Month 6 and Month 12
Population: ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Denosumab 60 mg | Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo | Total hip | 1.46 Percent change | Standard Error 1.701 |
| Denosumab 60 mg | Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo | Femoral neck | 1.12 Percent change | Standard Error 2.668 |
| Denosumab 60 mg | Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo | Trochanter | 2.13 Percent change | Standard Error 2.762 |
Other Pre-specified
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline \* 100.
Time frame: Baseline and Month 12
Population: ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Denosumab 60 mg | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab | s-CTx | -63.36 Percent change |
| Denosumab 60 mg | Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab | s-PINP | -78.00 Percent change |
Other Pre-specified
Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by measure at Month 6 \* 100.
Time frame: Month 6 and Month 12
Population: ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Denosumab 60 mg | Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo | s-CTx | -50.90 Percent change |
| Denosumab 60 mg | Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo | s-PINP | -66.67 Percent change |
Other Pre-specified
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12
Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (\<50 or \>120 Bits Per Minutes \[bpm\]), Systolic Blood Pressure (\>170 Millimeters of Mercury \[mmHg\] or \<100 mmHg) and Heart rate (\>110 mmHg or \<50 mmHg) are summarized. Change from Baseline was calculated as the Month 12 value minus the Baseline value.
Time frame: Baseline and Month 12
Population: ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Denosumab 60 mg | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Diastolic blood pressure, High | 0 Participants |
| Denosumab 60 mg | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Diastolic blood pressure, Low | 2 Participants |
| Denosumab 60 mg | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Systolic blood pressure, High | 0 Participants |
| Denosumab 60 mg | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Systolic blood pressure, Low | 0 Participants |
| Denosumab 60 mg | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Heart rate, High | 0 Participants |
| Denosumab 60 mg | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Heart rate, Low | 0 Participants |
| Placebo | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Heart rate, High | 0 Participants |
| Placebo | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Diastolic blood pressure, High | 1 Participants |
| Placebo | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Systolic blood pressure, Low | 2 Participants |
| Placebo | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Diastolic blood pressure, Low | 0 Participants |
| Placebo | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Heart rate, Low | 0 Participants |
| Placebo | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12 | Systolic blood pressure, High | 2 Participants |
Other Pre-specified
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Time frame: From Month 6 to Month 12
Population: ITT-OL Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Denosumab 60 mg | Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase | Any AE | 22 Participants |
| Denosumab 60 mg | Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase | Any SAE | 1 Participants |
| Placebo | Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase | Any AE | 29 Participants |
| Placebo | Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase | Any SAE | 3 Participants |
Other Pre-specified
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12
Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 12 was summarized.
Time frame: Month 12
Population: ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Denosumab 60 mg | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12 | Neutralizing antibodies, Positive, n=0, 0 | NA Participants |
| Denosumab 60 mg | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12 | Neutralizing antibodies, Negative, n=0, 0 | NA Participants |
| Denosumab 60 mg | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12 | Binding antibodies, Positive, n=58, 61 | 0 Participants |
| Denosumab 60 mg | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12 | Binding antibodies, Negative, n=58, 61 | 58 Participants |
| Placebo | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12 | Binding antibodies, Negative, n=58, 61 | 61 Participants |
| Placebo | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12 | Neutralizing antibodies, Positive, n=0, 0 | NA Participants |
| Placebo | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12 | Binding antibodies, Positive, n=58, 61 | 0 Participants |
| Placebo | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12 | Neutralizing antibodies, Negative, n=0, 0 | NA Participants |