| Primary | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population | | Intention-to-Treat (ITT) Population. Last Observation Carried Forward (LOCF) at Week 52. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | 52 weeks / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0003.069(2.664 to 3.474)
- OG0013.302(2.890 to 3.715)
- OG0023.365(2.961 to 3.769)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANOVA | Fixed effects for treatment, pooled center and anticoagulant use. | | | Least Squares Mean Difference | -0.233 | | | 2-Sided | 95 | -0.812 | 0.345 | | | LS Mean Difference is 5 mg daily minus weekly treatment. | Yes | Non-Inferiority or Equivalence | To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%. |
|
| Secondary | Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT 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. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg IRBB | 5 mg immediate-release risedronate tablet daily, at least 30 minutes before breakfast for two years | | OG001 | 35 mg DRFB + DRBB | Combined two arms - 35 mg delayed-release following breakfast (DRFB) with 35 mg delayed-relase before breakfast (DRBB) |
| |
| Secondary | Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population | | ITT Population. Last Observation Carried Forward at Week 104. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| 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. | | Posted | | Number | | Percentage of Participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| 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. | ITT Population. Last Observation Carried Forward at Week 52. | Posted | | Number | | Percentage of Participants | | Week 52 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| 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. | | Posted | | Number | | Percentage of Participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| 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. | ITT Population. Last Observation Carried Forward at Week 104. | Posted | | Number | | Percentage of Participants | | Week 52 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population | | ITT Population. Last Observation Carried Forward at Week 52. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population | | ITT Population. Last Observation Carried Forward at Week 104. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population | | ITT Population. LOCF at Week 52. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population | | ITT Population. LOCF at Week 104. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint | | ITT Population. Last Observation Carried Forward at Week 52. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint | | ITT Population. Last Observation Carried Forward at Week 104. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 13 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population | | ITT Population. Last Observation Carried Forward at Week 52. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population | | ITT Population. Last Observation Carried Forward at Week 104. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 13 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population | | ITT Population. Last Observation Carried Forward at Week 52. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population | | ITT Population. Last Observation Carried Forward at Week 104. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 13 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population | | ITT Population. Last Observation Carried Forward at Week 52. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 52 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population | | | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population | | ITT Population. Last Observation Carried Forward at Week 104. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change | | Week 104 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Number of Patients With at Least One New Fractured Vertebra, Week 52 | | | Posted | | Number | | Participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population | | ITT Population. Last Observation Carried Forward at Week 52. | Posted | | Number | | Participants | | Week 52 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population | | | Posted | | Number | | Participants | | Week 104 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population | | ITT Population. Last Observation Carried Forward at Week 104. | Posted | | Number | | Participants | | Week 104 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Number of Patients With No New Fractured Vertebra, Week 52 | | | Posted | | Number | | Participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint | | ITT Population. Last Observation Carried Forward at Week 52. | Posted | | Number | | Participants | | Week 52 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Number of Patients With No New Fractured Vertebra, Week 104 | | | Posted | | Number | | Participants | | Week 104 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |
| Secondary | Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint | | ITT Population. Last Observation Carried Forward at Week 104. | Posted | | Number | | Participants | | Week 104 / Endpoint | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | | OG001 | 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | | OG002 | 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week |
| |