Trial · NCT00247273
A Study of Monthly Risedronate for Osteoporosis
NCT00247273, 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 Monthly Risedronate for Osteoporosis. Trials, record NCT00247273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00247273
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Monthly Risedronate for Osteoporosis
- NCT number
- NCT00247273
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,294 participants, actual
- Lead sponsor
- Warner Chilcott
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- risedronate, risedronate
- First posted
- 2005-11-01
- Last updated
- 2013-04-22
- Results first posted
- 2011-06-21
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population | Baseline to Month 12 - Endpoint | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12). |
| Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population | Baseline to Month 12 | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. |
| Secondary | Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population | Baseline to Month 12 | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. |
| Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24) | Baseline to Month 24 - Endpoint | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24). |
| Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population | Baseline to Month 24 | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. |
| Secondary | Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population | Baseline to Month 24 | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. |
| Secondary | Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population | Baseline to Month 6 | Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine |
| Secondary | Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population | Baseline to Month 6 | Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24. |
| Secondary | Change From Baseline in Urine NTX/Cr at Month 24, ITT Population | Baseline to Month 24 | Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24. |
| Secondary | Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population | Baseline to Month 24 | Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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 in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population | Baseline to Month 12 - Endpoint | ITT (intent to treat) Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population | Baseline to Month 12 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population | Baseline to Month 12 | ITT | g/cm^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24) | Baseline to Month 24 - Endpoint | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population | Baseline to Month 24 | ITT | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population | Baseline to Month 24 | ITT | g/cm^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population | Baseline to Month 6 | ITT | nmol BCE / mmol Creatinine | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population | Baseline to Month 6 | ITT | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Urine NTX/Cr at Month 24, ITT Population | Baseline to Month 24 | ITT | nmol BCE / mmol Creatinine | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population | Baseline to Month 24 | ITT | Percent Change | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group40
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 in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population | 5 mg Risedronate | 3.425 | 95% Confidence Interval 3.028 to 3.823 | Percent Change | |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population | 150 mg Risedronate | 3.540 | 95% Confidence Interval 3.147 to 3.934 | Percent Change | |
| Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population | 5 mg Risedronate | 3.522 | 95% Confidence Interval 3.116 to 3.928 | Percent Change | |
| Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population | 150 mg Risedronate | 3.598 | 95% Confidence Interval 3.201 to 3.995 | Percent Change | |
| Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population | 5 mg Risedronate | 0.0256 | 95% Confidence Interval 0.0226 to 0.0286 | g/cm^2 | |
| Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population | 150 mg Risedronate | 0.0261 | 95% Confidence Interval 0.0232 to 0.0291 | g/cm^2 | |
| Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24) | 5 mg Risedronate | 3.927 | 95% Confidence Interval 3.432 to 4.422 | Percent Change | |
| Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24) | 150 mg Risedronate | 4.166 | 95% Confidence Interval 3.677 to 4.654 | Percent Change | |
| Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population | 5 mg Risedronate | 4.217 | 95% Confidence Interval 3.685 to 4.750 | Percent Change | |
| Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population | 150 mg Risedronate | 4.302 | 95% Confidence Interval 3.783 to 4.822 | Percent Change |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5 mg Risedronate | 644 | |
| Overall Study | STARTED | 150 mg Risedronate | 650 | |
| Overall Study | Intent to Treat Population | 5 mg Risedronate | 642 | |
| Overall Study | Intent to Treat Population | 150 mg Risedronate | 650 | |
| Overall Study | COMPLETED | 5 mg Risedronate | 498 | |
| Overall Study | COMPLETED | 150 mg Risedronate | 513 | |
| Overall Study | NOT COMPLETED | 5 mg Risedronate | 146 | |
| Overall Study | NOT COMPLETED | 150 mg Risedronate | 137 |
Source ClinicalTrials.gov
Adverse events370
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 | Influenza | Infections and infestations | 5 mg Risedronate | 57 | 642 | 62 |
| other | Influenza | Infections and infestations | 150 mg Risedronate | 94 | 650 | 112 |
| other | Nasopharyngitis | Infections and infestations | 5 mg Risedronate | 62 | 642 | 76 |
| other | Nasopharyngitis | Infections and infestations | 150 mg Risedronate | 70 | 650 | 86 |
| other | Urinary Tract Infection | Infections and infestations | 5 mg Risedronate | 50 | 642 | 58 |
| other | Urinary Tract Infection | Infections and infestations | 150 mg Risedronate | 61 | 650 | 83 |
| other | Bronchitis | Infections and infestations | 5 mg Risedronate | 68 | 642 | 76 |
| other | Bronchitis | Infections and infestations | 150 mg Risedronate | 57 | 650 | 74 |
| other | Diarrrhoea | Gastrointestinal disorders | 5 mg Risedronate | 43 | 642 | 49 |
| other | Diarrrhoea | Gastrointestinal disorders | 150 mg Risedronate | 69 | 650 | 95 |
1 to 10 of 370Source ClinicalTrials.gov
See all 370 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5 mg Risedronate | ||
| Total, all-cause mortality | 150 mg Risedronate | ||
| Total, other adverse events | 5 mg Risedronate | 554 | 642 |
| Total, other adverse events | 150 mg Risedronate | 578 | 650 |
| Total, serious adverse events | 5 mg Risedronate | 51 | 642 |
| Total, serious adverse events | 150 mg Risedronate | 77 | 650 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 5 mg Risedronate vs 150 mg Risedronate: Number of Participants With New Vertebral Fracture at Month 12, ITT Population | Trial comparisons |
| 5 mg Risedronate vs 150 mg Risedronate: Number of Participants With New Vertebral Fracture at Month 24, ITT Population | Trial comparisons |
| 5 mg Risedronate vs 150 mg Risedronate: serious adverse events | Trial comparisons |
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/NCT00247273
GET https://conductscience.org/api/trials/v1/NCT00247273/results?page=2