Last reviewed · How we verify
Active-controlled, Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly in Postmenopausal Women With Low Bone Mineral Density
A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.
Details
| Lead sponsor | Warner Chilcott |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 370 |
| Start date | 2004-04 |
| Completion | 2005-06 |
Conditions
- Postmenopausal
Interventions
- risedronate
- risedronate
- risedronate
- experimental
Primary outcomes
- Evaluate the safety of 3 once-monthly dosing regimens of risedronate, 100 mg, 150 mg and 200 mg, compared to a once-daily dosing regimen, 5 mg, as assessed by clinical laboratory values and adverse event (AE) profiles — 6 months
Countries
United States, Canada, Croatia, Netherlands, Poland