Trials / Completed
CompletedNCT00247273
A Study of Monthly Risedronate for Osteoporosis
A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,294 (actual)
- Sponsor
- Warner Chilcott · Industry
- Sex
- Female
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
Detailed description
The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | risedronate | tablet, 5 mg risedronate, once a day for 2 years |
| DRUG | risedronate | oral, 150 mg risedronate, once a month for 2 years |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2008-03-01
- Completion
- 2008-04-01
- First posted
- 2005-11-01
- Last updated
- 2013-04-22
- Results posted
- 2011-06-21
Locations
49 sites across 14 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Estonia, Finland, France, Hungary, Lebanon, Norway, Poland, Spain
Source: ClinicalTrials.gov record NCT00247273. Inclusion in this directory is not an endorsement.