NCT00577837

Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Postmenopausal

Interventions

Type	Name	Description
DRUG	risedronate	tablet, 5 mg risedronate daily for 6 months
DRUG	risedronate	tablet, 100 mg risedronate monthly for 6 months
DRUG	risedronate	tablet, 150 mg risedronate monthly for 6 months
DRUG	experimental	tablet, 200 mg risedronate monthly for 6 months

Timeline

• Start date: 2004-04-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2007-12-20
• Last updated: 2013-04-17

Locations

14 sites across 5 countries: United States, Canada, Croatia, Netherlands, Poland