Trial · NCT00541658
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
NCT00541658, Phase 3, Completed, Warner Chilcott; results first posted 2011-06-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis. Trials, record NCT00541658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00541658
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
- NCT number
- NCT00541658
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 923 participants, actual
- Lead sponsor
- Warner Chilcott
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- risedronate, risedronate, risedronate
- First posted
- 2007-10-10
- Last updated
- 2013-04-22
- Results first posted
- 2011-06-21
Source ClinicalTrials.gov
Registered outcomes51
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population | 52 weeks / Endpoint | |
| Secondary | Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population | Week 52 / Endpoint | |
| Secondary | Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population | Week 26 | |
| Secondary | Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population | Week 52 | |
| Secondary | Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population | Week 104 | |
| Secondary | Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population | Week 104 / Endpoint | |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 registered outcomesOutcomes51
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population | 52 weeks / Endpoint | Intention-to-Treat (ITT) Population. Last Observation Carried Forward (LOCF) at Week 52. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population | Week 52 / Endpoint | 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. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population | Week 26 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population | Week 52 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population | Week 104 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population | Week 104 / Endpoint | ITT Population. Last Observation Carried Forward at Week 104. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population | Week 52 | ITT Population. | Percentage of Participants | NUMBER |
| SECONDARY | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population | Week 52 / Endpoint | ITT Population. Last Observation Carried Forward at Week 52. | Percentage of Participants | NUMBER |
| SECONDARY | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population | Week 52 | ITT Population | Percentage of Participants | NUMBER |
| SECONDARY | Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population | Week 52 / Endpoint | ITT Population. Last Observation Carried Forward at Week 104. | Percentage of Participants | NUMBER |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 outcomesResults by group152
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population | 5 mg Before Breakfast | 3.069 | 95% Confidence Interval 2.664 to 3.474 | Percent Change | |
| Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population | 35 mg After Breakfast | 3.302 | 95% Confidence Interval 2.890 to 3.715 | Percent Change | |
| Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population | 35 mg Before Breakfast | 3.365 | 95% Confidence Interval 2.961 to 3.769 | Percent Change | |
| Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population | 5 mg IRBB | 3.069 | 95% Confidence Interval 2.664 to 3.474 | Percent Change | |
| Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population | 35 mg DRFB + DRBB | 3.334 | 95% Confidence Interval 3.046 to 3.622 | Percent Change | |
| Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population | 5 mg Before Breakfast | 2.685 | 95% Confidence Interval 2.305 to 3.066 | Percent Change | |
| Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population | 35 mg After Breakfast | 2.816 | 95% Confidence Interval 2.429 to 3.203 | Percent Change | |
| Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population | 35 mg Before Breakfast | 2.529 | 95% Confidence Interval 2.148 to 2.910 | Percent Change | |
| Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population | 5 mg Before Breakfast | 3.035 | 95% Confidence Interval 2.627 to 3.443 | Percent Change | |
| Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population | 35 mg After Breakfast | 3.293 | 95% Confidence Interval 2.883 to 3.702 | Percent Change |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5 mg Before Breakfast | 308 | |
| Overall Study | STARTED | 35 mg After Breakfast | 307 | |
| Overall Study | STARTED | 35 mg Before Breakfast | 308 | |
| Overall Study | ITT Population | 5 mg Before Breakfast | 307 | |
| Overall Study | ITT Population | 35 mg After Breakfast | 307 | |
| Overall Study | ITT Population | 35 mg Before Breakfast | 308 | |
| Overall Study | COMPLETED | 5 mg Before Breakfast | 248 | |
| Overall Study | COMPLETED | 35 mg After Breakfast | 234 | |
| Overall Study | COMPLETED | 35 mg Before Breakfast | 240 | |
| Overall Study | NOT COMPLETED | 5 mg Before Breakfast | 60 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events606
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Discomfort | Gastrointestinal disorders | 5 mg Before Breakfast | 1 | 307 | 1 |
| other | Abdominal Discomfort | Gastrointestinal disorders | 35 mg After Breakfast | 3 | 307 | 3 |
| other | Abdominal Discomfort | Gastrointestinal disorders | 35 mg Before Breakfast | 6 | 308 | 8 |
| other | Abdominal Distension | Gastrointestinal disorders | 5 mg Before Breakfast | 4 | 307 | 4 |
| other | Abdominal Distension | Gastrointestinal disorders | 35 mg After Breakfast | 3 | 307 | 3 |
| other | Abdominal Distension | Gastrointestinal disorders | 35 mg Before Breakfast | 2 | 308 | 2 |
| other | Abdominal Pain | Gastrointestinal disorders | 5 mg Before Breakfast | 10 | 307 | 11 |
| other | Abdominal Pain | Gastrointestinal disorders | 35 mg After Breakfast | 19 | 307 | 21 |
| other | Abdominal Pain | Gastrointestinal disorders | 35 mg Before Breakfast | 20 | 308 | 23 |
| other | Abdominal Pain Lower | Gastrointestinal disorders | 5 mg Before Breakfast | 4 | 307 | 4 |
1 to 10 of 606Source ClinicalTrials.gov
See all 606 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5 mg Before Breakfast | ||
| Total, all-cause mortality | 35 mg After Breakfast | ||
| Total, all-cause mortality | 35 mg Before Breakfast | ||
| Total, other adverse events | 5 mg Before Breakfast | 243 | 307 |
| Total, other adverse events | 35 mg After Breakfast | 250 | 307 |
| Total, other adverse events | 35 mg Before Breakfast | 264 | 308 |
| Total, serious adverse events | 5 mg Before Breakfast | 31 | 307 |
| Total, serious adverse events | 35 mg After Breakfast | 32 | 307 |
| Total, serious adverse events | 35 mg Before Breakfast | 32 | 308 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21947137 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00541658
GET https://conductscience.org/api/trials/v1/NCT00541658/registered?page=2