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NCT00358176 · ClinicalTrials.gov registry record · Phase 3
Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,231
- Enrollment target
NCT00358176 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,231 participants.
The verdict
NCT00358176, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,231 participants
- Enrollment target
Study Summary
To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis. To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption. To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.
Interventions
- DRUG Risedronate (HMR4003)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,231 participants |
| Start Date | 2004-07 |
| Est. Completion | 2007-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00358176
The ClinicalTrials.gov registry entry for NCT00358176 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,231 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.
NCT00358176 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00358176 about?
NCT00358176 is a clinical study titled "Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women". To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis. To confirm the efficacy of 75 mg risedronate tablets taken on 2 co...
What is the current status of trial NCT00358176?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,231 participants. The study started on 2004-07. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00358176?
The interventions under investigation include: Risedronate (HMR4003) (DRUG).
Who is sponsoring clinical trial NCT00358176?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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