Trial · NCT00577720
Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate
NCT00577720, Phase 2, Completed, Warner Chilcott; results first posted 2012-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate. Trials, record NCT00577720. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00577720
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate
- NCT number
- NCT00577720
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 181 participants, actual
- Lead sponsor
- Warner Chilcott
- Conditions
- Postmenopausal Women
- Interventions
- risedronate, risedronate, risedronate, risedronate
- First posted
- 2007-12-20
- Last updated
- 2012-01-13
- Results first posted
- 2012-01-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population | Baseline and Week 13 | |
| Secondary | Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population | Baseline and Week 13 | |
| Secondary | Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population | Baseline and Week 13 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population | Baseline and Week 13 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population | Baseline and Week 13 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population | Baseline and Week 13 | ITT Population | Percent Change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population | 35 mg IRBB (Immediate Release Before Breakfast) | -43.20 | 95% Confidence Interval -55.83 to -30.58 | Percent Change | |
| Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population | 35 mg DRFB (Delayed Release Following Breakfast) | -62.08 | 95% Confidence Interval -73.59 to -50.56 | Percent Change | |
| Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population | 50 mg DRFB | -65.11 | 95% Confidence Interval -77.70 to -52.52 | Percent Change | |
| Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population | 50 mg DRBB (Delayed Release Before Breakfast) | -66.30 | 95% Confidence Interval -77.42 to -55.18 | Percent Change | |
| Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population | 35 mg IRBB (Immediate Release Before Breakfast) | -38.57 | 95% Confidence Interval -56.60 to -20.54 | Percent Change | |
| Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population | 35 mg DRFB (Delayed Release Following Breakfast) | -46.60 | 95% Confidence Interval -63.04 to -30.17 | Percent Change | |
| Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population | 50 mg DRFB | -43.65 | 95% Confidence Interval -61.62 to -25.67 | Percent Change | |
| Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population | 50 mg DRBB (Delayed Release Before Breakfast) | -54.27 | 95% Confidence Interval -70.14 to -38.40 | Percent Change | |
| Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population | 35 mg IRBB (Immediate Release Before Breakfast) | -10.99 | 95% Confidence Interval -19.62 to -2.365 | Percent Change | |
| Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population | 35 mg DRFB (Delayed Release Following Breakfast) | -10.41 | 95% Confidence Interval -18.28 to -2.545 | Percent Change |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 35 mg IRBB (Immediate Release Before Breakfast) | 37 | |
| Overall Study | STARTED | 35 mg DRFB (Delayed Release Following Breakfast) | 36 | |
| Overall Study | STARTED | 50 mg DRFB | 36 | |
| Overall Study | STARTED | 50 mg DRBB (Delayed Release Before Breakfast) | 72 | |
| Overall Study | ITT (Intent to Treat) Population | 35 mg IRBB (Immediate Release Before Breakfast) | 34 | |
| Overall Study | ITT (Intent to Treat) Population | 35 mg DRFB (Delayed Release Following Breakfast) | 35 | |
| Overall Study | ITT (Intent to Treat) Population | 50 mg DRFB | 35 | |
| Overall Study | ITT (Intent to Treat) Population | 50 mg DRBB (Delayed Release Before Breakfast) | 65 | |
| Overall Study | COMPLETED | 35 mg IRBB (Immediate Release Before Breakfast) | 33 | |
| Overall Study | COMPLETED | 35 mg DRFB (Delayed Release Following Breakfast) | 35 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events312
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 | Back Pain | Musculoskeletal and connective tissue disorders | 35 mg IRBB (Immediate Release Before Breakfast) | 3 | 37 | 3 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | 35 mg DRFB (Delayed Release Following Breakfast) | 4 | 36 | 4 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | 50 mg DRFB | 0 | 36 | 0 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | 50 mg DRBB (Delayed Release Before Breakfast) | 3 | 72 | 3 |
| other | Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | 35 mg IRBB (Immediate Release Before Breakfast) | 2 | 37 | 2 |
| other | Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | 35 mg DRFB (Delayed Release Following Breakfast) | 2 | 36 | 2 |
| other | Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | 50 mg DRFB | 1 | 36 | 1 |
| other | Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | 50 mg DRBB (Delayed Release Before Breakfast) | 3 | 72 | 3 |
| other | Pain in Extremity | Musculoskeletal and connective tissue disorders | 35 mg IRBB (Immediate Release Before Breakfast) | 0 | 37 | 0 |
| other | Pain in Extremity | Musculoskeletal and connective tissue disorders | 35 mg DRFB (Delayed Release Following Breakfast) | 2 | 36 | 2 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 35 mg IRBB (Immediate Release Before Breakfast) | ||
| Total, all-cause mortality | 35 mg DRFB (Delayed Release Following Breakfast) | ||
| Total, all-cause mortality | 50 mg DRFB | ||
| Total, all-cause mortality | 50 mg DRBB (Delayed Release Before Breakfast) | ||
| Total, other adverse events | 35 mg IRBB (Immediate Release Before Breakfast) | 27 | 37 |
| Total, other adverse events | 35 mg DRFB (Delayed Release Following Breakfast) | 19 | 36 |
| Total, other adverse events | 50 mg DRFB | 24 | 36 |
| Total, other adverse events | 50 mg DRBB (Delayed Release Before Breakfast) | 51 | 72 |
| Total, serious adverse events | 35 mg IRBB (Immediate Release Before Breakfast) | 0 | 37 |
| Total, serious adverse events | 35 mg DRFB (Delayed Release Following Breakfast) | 1 | 36 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT00577720
GET https://conductscience.org/api/trials/v1/NCT00577720/events?page=2