Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00402441 · ClinicalTrials.gov registry record · Phase 4
Risedronate in the Prevention of Osteoporosis in Postmenopausal Women
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 260
- Enrollment target
NCT00402441 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 260 participants.
The verdict
NCT00402441, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 260 participants
- Enrollment target
Study Summary
Primary Objective: * To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal. Secondary objectives: * To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1 year of treatment in women who are 0.5-5 years postmenopausal * To assess the general safety of 35-mg risedronate administered once weekly.
Interventions
- DRUG Risedronate (HMR4003)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2002-09 |
| Est. Completion | 2004-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00402441
The ClinicalTrials.gov registry entry for NCT00402441 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Risedronate (HMR4003) is the first listed.
NCT00402441 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00402441 about?
NCT00402441 is a clinical study titled "Risedronate in the Prevention of Osteoporosis in Postmenopausal Women". Primary Objective: * To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal. Secondary objectives: * T...
What is the current status of trial NCT00402441?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 260 participants. The study started on 2002-09. Estimated completion is 2004-06.
What interventions are being tested in trial NCT00402441?
The interventions under investigation include: Risedronate (HMR4003) (DRUG).
Who is sponsoring clinical trial NCT00402441?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.