Postmenopausal Osteoporosis
Conditions
Brief summary
The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
Detailed description
The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.
Interventions
DRUGrisedronate
5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily
Sponsors
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female: 50 years of age or older * \>5 years since last menses natural or surgical * have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture
Exclusion criteria
* history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia * BMI \>32 kg/m * use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone * hypocalcemia or hypercalcemia of any cause * markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population | 52 weeks / Endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With No New Fractured Vertebra, Week 104 | Week 104 | — |
| Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population | Week 104 / Endpoint | — |
| Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population | Week 104 | — |
| Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint | Week 52 / Endpoint | — |
| Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population | Week 104 / Endpoint | — |
| Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population | Week 52 / Endpoint | — |
| Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population | Week 26 | — |
| Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population | Week 52 | — |
| Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population | Week 104 | — |
| Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population | Week 52 | Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. |
| Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population | Week 52 / Endpoint | Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. |
| Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population | Week 52 | Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. |
| Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population | Week 52 / Endpoint | Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint. |
| Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population | Week 26 | — |
| Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population | Week 52 | — |
| Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population | Week 52 / Endpoint | — |
| Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population | Week 104 | — |
| Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population | Week 104 / Endpoint | — |
| Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population | Week 26 | — |
| Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population | Week 52 | — |
| Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population | Week 52 / Endpoint | — |
| Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population | Week 104 | — |
| Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population | Week 104 / Endpoint | — |
| Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population | Week 26 | — |
| Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population | Week 52 | — |
| Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint | Week 52 / Endpoint | — |
| Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population | Week 104 | — |
| Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint | Week 104 / Endpoint | — |
| Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population | Week 13 | — |
| Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population | Week 26 | — |
| Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population | Week 52 | — |
| Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population | Week 52 / Endpoint | — |
| Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population | Week 104 | — |
| Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population | Week 104 / Endpoint | — |
| Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population | Week 13 | — |
| Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population | Week 26 | — |
| Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population | Week 52 | — |
| Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population | Week 52 / Endpoint | — |
| Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population | Week 104 | — |
| Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population | Week 104 / Endpoint | — |
| Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population | Week 13 | — |
| Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population | Week 26 | — |
| Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population | Week 52 | — |
| Number of Patients With No New Fractured Vertebra, Week 52 | Week 52 | — |
| Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population | Week 104 | — |
| Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population | Week 104 / Endpoint | — |
| Number of Patients With at Least One New Fractured Vertebra, Week 52 | Week 52 | — |
| Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population | Week 52 / Endpoint | — |
| Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint | Week 104 / Endpoint | — |
| Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population | Week 52 / Endpoint | — |
Countries
Argentina, Belgium, Canada, Estonia, France, Hungary, Poland, United States
Participant flow
Recruitment details
923 women with PMO at 43 sites in 8 countries across North America, South America, and the European Union. Patients were randomized within a site to 1 of 3 treatment groups (35 mg delayed-release Risedronate, given once-weekly before/after breakfast, and 5 mg immediate-release Risedronate, administered once-daily before breakfast) in a 1:1:1 ratio.
Participants by arm
| Arm | Count |
|---|---|
| 5 mg Before Breakfast 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | 308 |
| 35 mg After Breakfast 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | 307 |
| 35 mg Before Breakfast 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week | 308 |
| Total | 923 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 28 | 37 | 25 |
| Overall Study | Lost to Follow-up | 3 | 3 | 6 |
| Overall Study | Physician Decision | 0 | 0 | 4 |
| Overall Study | Protocol Violation | 0 | 1 | 1 |
| Overall Study | Took No Study Drug | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 28 | 32 | 32 |
Baseline characteristics
| Characteristic | 5 mg Before Breakfast | 35 mg After Breakfast | 35 mg Before Breakfast | Total |
|---|---|---|---|---|
| Age Continuous | 65.3 years STANDARD_DEVIATION 7.4 | 65.8 years STANDARD_DEVIATION 7.4 | 66.0 years STANDARD_DEVIATION 7.5 | 65.7 years STANDARD_DEVIATION 7.4 |
| Age, Customized < 65 years | 141 participants | 127 participants | 133 participants | 401 participants |
| Age, Customized > = 75 years | 38 participants | 39 participants | 42 participants | 119 participants |
| Age, Customized Between 65 and < 75 years | 128 participants | 141 participants | 133 participants | 402 participants |
| Gender Female | 307 participants | 307 participants | 308 participants | 922 participants |
| Gender Male | 0 participants | 0 participants | 0 participants | 0 participants |
| Region of Enrollment Argentina | 88 participants | 85 participants | 84 participants | 257 participants |
| Region of Enrollment Belgium | 4 participants | 5 participants | 3 participants | 12 participants |
| Region of Enrollment Canada | 7 participants | 7 participants | 9 participants | 23 participants |
| Region of Enrollment Estonia | 53 participants | 53 participants | 52 participants | 158 participants |
| Region of Enrollment France | 19 participants | 23 participants | 18 participants | 60 participants |
| Region of Enrollment Hungary | 35 participants | 34 participants | 33 participants | 102 participants |
| Region of Enrollment Poland | 56 participants | 57 participants | 58 participants | 171 participants |
| Region of Enrollment United States | 46 participants | 43 participants | 51 participants | 140 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 243 / 307 | 250 / 307 | 264 / 308 |
| serious Total, serious adverse events | 31 / 307 | 32 / 307 | 32 / 308 |
Outcome results
Primary
Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population
Time frame: 52 weeks / Endpoint
Population: Intention-to-Treat (ITT) Population. Last Observation Carried Forward (LOCF) at Week 52.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population | 3.069 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population | 3.302 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population | 3.365 Percent Change |
95% CI: [-0.812, 0.345]ANOVA
95% CI: [-0.869, 0.277]ANOVA
Secondary
Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population
Time frame: Week 104 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 104.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Before Breakfast | Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population | 5 Participants |
| 35 mg After Breakfast | Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population | 2 Participants |
| 35 mg Before Breakfast | Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population | 6 Participants |
p-value: 0.450595% CI: [0.08, 2.11]Fisher Exact
p-value: 0.771995% CI: [0.37, 3.9]Fisher Exact
Secondary
Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population
Time frame: Week 104
Population: ITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Before Breakfast | Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population | 5 Participants |
| 35 mg After Breakfast | Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population | 2 Participants |
| 35 mg Before Breakfast | Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population | 4 Participants |
p-value: 0.450595% CI: [0.08, 2.14]Fisher Exact
p-value: 195% CI: [0.22, 3.03]Fisher Exact
Secondary
Number of Patients With at Least One New Fractured Vertebra, Week 52
Time frame: Week 52
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Before Breakfast | Number of Patients With at Least One New Fractured Vertebra, Week 52 | 2 Participants |
| 35 mg After Breakfast | Number of Patients With at Least One New Fractured Vertebra, Week 52 | 2 Participants |
| 35 mg Before Breakfast | Number of Patients With at Least One New Fractured Vertebra, Week 52 | 3 Participants |
p-value: 195% CI: [0.14, 7.05]Fisher Exact
p-value: 195% CI: [0.25, 8.9]Fisher Exact
Secondary
Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population
Time frame: Week 52 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 52.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Before Breakfast | Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population | 2 Participants |
| 35 mg After Breakfast | Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population | 2 Participants |
| 35 mg Before Breakfast | Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population | 3 Participants |
p-value: 195% CI: [0.15, 7.29]Fisher Exact
p-value: 195% CI: [0.25, 8.87]Fisher Exact
Secondary
Number of Patients With No New Fractured Vertebra, Week 104
Time frame: Week 104
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Before Breakfast | Number of Patients With No New Fractured Vertebra, Week 104 | 239 Participants |
| 35 mg After Breakfast | Number of Patients With No New Fractured Vertebra, Week 104 | 231 Participants |
| 35 mg Before Breakfast | Number of Patients With No New Fractured Vertebra, Week 104 | 233 Participants |
p-value: 0.450595% CI: [0.08, 2.14]Fisher Exact
p-value: 195% CI: [0.22, 3.03]Fisher Exact
Secondary
Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint
Time frame: Week 104 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 104.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Before Breakfast | Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint | 269 Participants |
| 35 mg After Breakfast | Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint | 263 Participants |
| 35 mg Before Breakfast | Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint | 267 Participants |
p-value: 0.450595% CI: [0.08, 2.11]Fisher Exact
p-value: 0.771995% CI: [0.37, 3.9]Fisher Exact
Secondary
Number of Patients With No New Fractured Vertebra, Week 52
Time frame: Week 52
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Before Breakfast | Number of Patients With No New Fractured Vertebra, Week 52 | 255 Participants |
| 35 mg After Breakfast | Number of Patients With No New Fractured Vertebra, Week 52 | 255 Participants |
| 35 mg Before Breakfast | Number of Patients With No New Fractured Vertebra, Week 52 | 254 Participants |
p-value: 195% CI: [0.14, 7.05]Fisher Exact
p-value: 195% CI: [0.25, 8.9]Fisher Exact
Secondary
Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint
Time frame: Week 52 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 52.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Before Breakfast | Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint | 268 Participants |
| 35 mg After Breakfast | Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint | 259 Participants |
| 35 mg Before Breakfast | Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint | 268 Participants |
p-value: 195% CI: [0.15, 7.29]Fisher Exact
p-value: 195% CI: [0.25, 8.87]Fisher Exact
Secondary
Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population
Time frame: Week 26
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population | 1.900 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population | 2.148 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population | 2.164 Percent Change |
95% CI: [-0.86, 0.363]ANOVA
95% CI: [-0.871, 0.342]ANOVA
Secondary
Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population
Time frame: Week 104 / Endpoint
Population: ITT Population. LOCF at Week 104.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population | 1.431 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population | 1.986 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population | 2.047 Percent Change |
95% CI: [-1.128, 0.018]ANOVA
95% CI: [-1.185, -0.046]ANOVA
Secondary
Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population
Time frame: Week 104
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population | 1.530 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population | 2.108 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population | 2.328 Percent Change |
95% CI: [-1.189, 0.032]ANOVA
95% CI: [-1.403, -0.194]ANOVA
Secondary
Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population
Time frame: Week 26
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population | 1.120 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population | 1.385 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population | 1.246 Percent Change |
95% CI: [-0.731, 0.201]ANOVA
95% CI: [-0.588, 0.336]ANOVA
Secondary
Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population
Time frame: Week 52 / Endpoint
Population: ITT Population. LOCF at Week 52.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population | 1.180 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population | 1.507 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population | 1.717 Percent Change |
95% CI: [-0.793, 0.138]ANOVA
95% CI: [-1, -0.074]ANOVA
Secondary
Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population
Time frame: Week 52
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population | 1.155 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population | 1.482 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population | 1.717 Percent Change |
95% CI: [-0.811, 0.156]ANOVA
95% CI: [-1.045, -0.08]ANOVA
Secondary
Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint
Time frame: Week 104 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 104.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint | 2.772 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint | 3.691 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint | 3.828 Percent Change |
95% CI: [-1.655, -0.184]ANOVA
95% CI: [-1.787, -0.326]ANOVA
Secondary
Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population
Time frame: Week 104
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population | 3.056 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population | 4.152 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population | 4.246 Percent Change |
95% CI: [-1.861, -0.329]ANOVA
95% CI: [-1.948, -0.432]ANOVA
Secondary
Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint
Time frame: Week 52 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 52.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint | 2.186 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint | 2.732 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint | 2.764 Percent Change |
95% CI: [-1.17, 0.078]ANOVA
95% CI: [-1.199, 0.042]ANOVA
Secondary
Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population
Time frame: Week 52
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population | 2.297 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population | 2.854 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population | 2.819 Percent Change |
95% CI: [-1.185, 0.071]ANOVA
95% CI: [-1.149, 0.105]ANOVA
Secondary
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population
Time frame: Week 104 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 104.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population | -32.572 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population | -34.769 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population | -34.824 Percent Change |
95% CI: [-1.318, 5.711]ANOVA
95% CI: [-1.248, 5.751]ANOVA
Secondary
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population
Time frame: Week 104
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population | -33.394 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population | -36.143 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population | -36.810 Percent Change |
95% CI: [-0.938, 6.436]ANOVA
95% CI: [-0.255, 7.087]ANOVA
Secondary
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population
Time frame: Week 13
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population | -23.386 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population | -25.141 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population | -25.191 Percent Change |
95% CI: [-1.145, 4.655]ANOVA
95% CI: [-1.087, 4.698]ANOVA
Secondary
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population
Time frame: Week 26
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population | -31.273 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population | -33.680 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population | -32.582 Percent Change |
95% CI: [-0.502, 5.316]ANOVA
95% CI: [-1.576, 4.194]ANOVA
Secondary
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population
Time frame: Week 52 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 52.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population | -31.367 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population | -32.802 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population | -32.829 Percent Change |
95% CI: [-1.652, 4.521]ANOVA
95% CI: [-1.611, 4.535]ANOVA
Secondary
Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population
Time frame: Week 52
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population | -31.895 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population | -33.450 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population | -33.507 Percent Change |
95% CI: [-1.617, 4.727]ANOVA
95% CI: [-1.556, 4.779]ANOVA
Secondary
Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population
Time frame: Week 104 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 104.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population | -41.451 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population | -49.253 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population | -48.752 Percent Change |
95% CI: [1.385, 14.22]ANOVA
95% CI: [0.911, 13.69]ANOVA
Secondary
Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population
Time frame: Week 104
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population | -44.155 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population | -51.985 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population | -52.538 Percent Change |
95% CI: [1.175, 14.485]ANOVA
95% CI: [1.757, 15.01]ANOVA
Secondary
Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population
Time frame: Week 52 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 52.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population | -42.172 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population | -48.724 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population | -47.703 Percent Change |
95% CI: [1.162, 11.942]ANOVA
95% CI: [0.164, 10.897]ANOVA
Secondary
Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population
Time frame: Week 52
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population | -44.410 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population | -49.185 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population | -50.048 Percent Change |
95% CI: [-0.514, 10.065]ANOVA
95% CI: [0.356, 10.92]ANOVA
Secondary
Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population
Time frame: Week 26
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population | 1.613 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population | 1.748 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population | 1.685 Percent Change |
95% CI: [-0.504, 0.234]ANOVA
95% CI: [-0.437, 0.294]ANOVA
Secondary
Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population
Time frame: Week 52
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population | 1.809 Percent |
| 35 mg After Breakfast | Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population | 2.130 Percent |
| 35 mg Before Breakfast | Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population | 2.099 Percent |
95% CI: [-0.724, 0.082]ANOVA
95% CI: [-0.692, 0.112]ANOVA
Secondary
Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population
Time frame: Week 104 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 104.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population | 4.147 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population | 5.205 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population | 5.068 Percent Change |
95% CI: [-1.762, -0.355]ANOVA
95% CI: [-1.62, -0.223]ANOVA
Secondary
Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population
Time frame: Week 104
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population | 4.352 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population | 5.506 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population | 5.396 Percent Change |
95% CI: [-1.903, -0.405]ANOVA
95% CI: [-1.789, -0.299]ANOVA
Secondary
Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population
Time frame: Week 52 / Endpoint
Population: 35 mg group combined delayed-relase following breakfast (DRFB) group with delayed-relase before breakfast (DRBB) group and compared with 5 mg immediate-release before breakfast (IRBB) group. ITT Population. Last Observation Carried Forward at Week 52.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population | 3.069 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population | 3.334 Percent Change |
p-value: 0.295595% CI: [-0.763, 0.232]ANOVA
Secondary
Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population
Time frame: Week 26
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population | 2.685 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population | 2.816 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population | 2.529 Percent Change |
95% CI: [-0.674, 0.412]ANOVA
95% CI: [-0.382, 0.695]ANOVA
Secondary
Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population
Time frame: Week 52
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population | 3.035 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population | 3.293 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population | 3.357 Percent Change |
95% CI: [-0.836, 0.321]ANOVA
95% CI: [-0.9, 0.256]ANOVA
Secondary
Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population
Time frame: Week 13
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population | -42.331 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population | -46.781 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population | -46.054 Percent Change |
95% CI: [-0.26, 9.16]ANOVA
95% CI: [-0.975, 8.421]ANOVA
Secondary
Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population
Time frame: Week 26
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population | -44.386 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population | -49.183 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population | -49.358 Percent Change |
95% CI: [-0.195, 9.79]ANOVA
95% CI: [0.02, 9.924]ANOVA
Secondary
Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population
Time frame: Week 104 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 104.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population | 2.028 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population | 2.551 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population | 2.496 Percent Change |
95% CI: [-1.03, -0.014]ANOVA
95% CI: [-0.973, 0.037]ANOVA
Secondary
Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population
Time frame: Week 104
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population | 2.177 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population | 2.821 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population | 2.764 Percent Change |
95% CI: [-1.179, -0.11]ANOVA
95% CI: [-1.116, -0.059]ANOVA
Secondary
Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population
Time frame: Week 52 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 52.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population | 1.785 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population | 2.073 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population | 2.075 Percent Change |
95% CI: [-0.682, 0.106]ANOVA
95% CI: [-0.681, 0.101]ANOVA
Secondary
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population
Time frame: Week 104 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 104.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population | -46.261 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population | -51.079 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population | -49.454 Percent Change |
95% CI: [-0.693, 10.327]ANOVA
95% CI: [-2.295, 8.68]ANOVA
Secondary
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population
Time frame: Week 104
Population: ITT Population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population | -49.188 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population | -53.927 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population | -53.186 Percent Change |
95% CI: [-0.793, 10.271]ANOVA
95% CI: [-1.518, 9.515]ANOVA
Secondary
Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population
Time frame: Week 13
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population | -42.595 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population | -46.366 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population | -45.420 Percent Change |
95% CI: [-0.885, 8.427]ANOVA
95% CI: [-1.819, 7.471]ANOVA
Secondary
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population
Time frame: Week 26
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population | -43.075 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population | -45.705 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population | -47.692 Percent Change |
95% CI: [-2.171, 7.431]ANOVA
95% CI: [-0.152, 9.386]ANOVA
Secondary
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population
Time frame: Week 52 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 52.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population | -40.227 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population | -46.599 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population | -44.630 Percent Change |
95% CI: [1.329, 11.414]ANOVA
95% CI: [-0.619, 9.425]ANOVA
Secondary
Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population
Time frame: Week 52
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 5 mg Before Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population | -42.223 Percent Change |
| 35 mg After Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population | -47.263 Percent Change |
| 35 mg Before Breakfast | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population | -46.863 Percent Change |
95% CI: [0.091, 9.989]ANOVA
95% CI: [-0.293, 9.574]ANOVA
Secondary
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population
Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Time frame: Week 52 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 104.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Before Breakfast | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population | 81.8 Percentage of Participants |
| 35 mg After Breakfast | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population | 87.9 Percentage of Participants |
| 35 mg Before Breakfast | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population | 90.1 Percentage of Participants |
p-value: 0.054795% CI: [1, 1.16]ANOVA
p-value: 0.006695% CI: [1.03, 1.18]ANOVA
Secondary
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population
Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Time frame: Week 52
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Before Breakfast | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population | 82.6 Percentage of Participants |
| 35 mg After Breakfast | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population | 89.2 Percentage of Participants |
| 35 mg Before Breakfast | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population | 92.3 Percentage of Participants |
p-value: 0.047695% CI: [1, 1.16]Fisher Exact
p-value: 0.001495% CI: [1.04, 1.2]ANOVA
Secondary
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population
Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Time frame: Week 52 / Endpoint
Population: ITT Population. Last Observation Carried Forward at Week 52.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Before Breakfast | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population | 81.5 Percentage of Participants |
| 35 mg After Breakfast | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population | 87.4 Percentage of Participants |
| 35 mg Before Breakfast | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population | 86.0 Percentage of Participants |
p-value: 0.072995% CI: [1, 1.15]Fisher Exact
p-value: 0.163995% CI: [0.98, 1.14]Fisher Exact
Secondary
Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population
Responder = a patient showing a positive change (\>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.
Time frame: Week 52
Population: ITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Before Breakfast | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population | 81 Percentage of Participants |
| 35 mg After Breakfast | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population | 87.5 Percentage of Participants |
| 35 mg Before Breakfast | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population | 86.4 Percentage of Participants |
p-value: 0.052495% CI: [1, 1.16]Fisher Exact
p-value: 0.120795% CI: [0.99, 1.15]Fisher Exact