NCT00918749

Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women

Study Assessing the Efficacy, Safety, and Pharmacokinetics of 75 and 100 mg Once-a-month Delayed-release Risedronate Formulations Compared to 150 mg Once-a-month Immediate-release Risedronate for 3 Months in Postmenopausal Women Age 45-80

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 months.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	150 mg	150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.
DRUG	75 mg	75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
DRUG	100 mg	100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-06-11
• Last updated: 2015-06-29
• Results posted: 2011-03-24

Locations

6 sites across 1 country: United States