NCT00577720

Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate

Study to Assess the Efficacy, Safety and Pharmacokinetics of Risedronate Upon Oral Administration of a 35 mg Delayed-Release, a 50 mg Delayed-Release or a 35 mg Immediate-Release Administered Weekly for 13 Weeks to Postmenopausal Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.

Detailed description

To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 minutes prior to breakfast) in postmenopausal women after 13 weeks of treatment.

Conditions

• Postmenopausal Women

Interventions

Type	Name	Description
DRUG	risedronate	35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks
DRUG	risedronate	35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
DRUG	risedronate	50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
DRUG	risedronate	50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2007-12-20
• Last updated: 2012-01-13
• Results posted: 2012-01-13

Locations

6 sites across 1 country: United States