Trial · NCT00918749
Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women
NCT00918749, Phase 2, Completed, Warner Chilcott; results first posted 2011-03-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women. Trials, record NCT00918749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00918749
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women
- NCT number
- NCT00918749
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 205 participants, actual
- Lead sponsor
- Warner Chilcott
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- 150 mg, 75 mg, 100 mg
- First posted
- 2009-06-11
- Last updated
- 2015-06-29
- Results first posted
- 2011-03-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population | Month 4 | Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence. |
| Secondary | Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | 2 months | |
| Secondary | Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | 3 months | |
| Secondary | Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | 2 months | Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA. |
| Secondary | Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | 3 months | ITT Population |
| Secondary | Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population | 4 months | ITT Population |
| Secondary | Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | 2 months | ITT Population |
| Secondary | Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | 3 months | ITT Population |
| Secondary | Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population | 4 months | ITT Population |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population | Month 4 | ITT Population | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | 2 months | ITT Population | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | 3 months | ITT Population | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | 2 months | ITT Population | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | 3 months | ITT Population | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population | 4 months | ITT Population | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | 2 months | ITT Population | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | 3 months | ITT Population | Percent Change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population | 4 months | ITT Population | Percent Change from Baseline | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population | 150 mg | -41.235 | Standard Error 2.995 | Percent Change from Baseline | |
| Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population | 75 mg | -44.832 | Standard Error 3.012 | Percent Change from Baseline | |
| Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population | 100 mg | -53.432 | Standard Error 3.025 | Percent Change from Baseline | |
| Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | 150 mg | -38.407 | Standard Error 3.504 | Percent Change from Baseline | |
| Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | 75 mg | -33.641 | Standard Error 3.538 | Percent Change from Baseline | |
| Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | 100 mg | -38.625 | Standard Error 3.547 | Percent Change from Baseline | |
| Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | 150 mg | -35.591 | Standard Error 3.045 | Percent Change from Baseline | |
| Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | 75 mg | -35.203 | Standard Error 3.034 | Percent Change from Baseline | |
| Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population | 100 mg | -46.379 | Standard Error 3.077 | Percent Change from Baseline | |
| Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population | 150 mg | -15.365 | Standard Error 6.567 | Percent Change from Baseline |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 150 mg | 70 | |
| Overall Study | STARTED | 75 mg | 66 | |
| Overall Study | STARTED | 100 mg | 69 | |
| Overall Study | ITT (Intent to Treat) Population | 150 mg | 69 | |
| Overall Study | ITT (Intent to Treat) Population | 75 mg | 66 | |
| Overall Study | ITT (Intent to Treat) Population | 100 mg | 69 | |
| Overall Study | COMPLETED | 150 mg | 63 | |
| Overall Study | COMPLETED | 75 mg | 63 | |
| Overall Study | COMPLETED | 100 mg | 62 | |
| Overall Study | NOT COMPLETED | 150 mg | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events123
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 | Diarrhoea | Gastrointestinal disorders | 150 mg | 11 | 69 | 14 |
| other | Diarrhoea | Gastrointestinal disorders | 75 mg | 15 | 66 | 20 |
| other | Diarrhoea | Gastrointestinal disorders | 100 mg | 15 | 69 | 18 |
| other | Abdominal Pain | Gastrointestinal disorders | 150 mg | 5 | 69 | 5 |
| other | Abdominal Pain | Gastrointestinal disorders | 75 mg | 16 | 66 | 18 |
| other | Abdominal Pain | Gastrointestinal disorders | 100 mg | 14 | 69 | 19 |
| other | Nausea | Gastrointestinal disorders | 150 mg | 6 | 69 | 8 |
| other | Nausea | Gastrointestinal disorders | 75 mg | 6 | 66 | 9 |
| other | Nausea | Gastrointestinal disorders | 100 mg | 9 | 69 | 12 |
| other | Vomiting | Gastrointestinal disorders | 150 mg | 3 | 69 | 3 |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 150 mg | ||
| Total, all-cause mortality | 75 mg | ||
| Total, all-cause mortality | 100 mg | ||
| Total, other adverse events | 150 mg | 50 | 69 |
| Total, other adverse events | 75 mg | 43 | 66 |
| Total, other adverse events | 100 mg | 49 | 69 |
| Total, serious adverse events | 150 mg | 0 | 69 |
| Total, serious adverse events | 75 mg | 0 | 66 |
| Total, serious adverse events | 100 mg | 0 | 69 |
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 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/NCT00918749
GET https://conductscience.org/api/trials/v1/NCT00918749/results?page=2