NCT00402441

Risedronate in the Prevention of Osteoporosis in Postmenopausal Women

A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 35-mg Risedronate Administered Once a Week in the Prevention of Osteoporosis in Postmenopausal Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Sanofi · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: * To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal. Secondary objectives: * To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1 year of treatment in women who are 0.5-5 years postmenopausal * To assess the general safety of 35-mg risedronate administered once weekly.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	Risedronate (HMR4003)

Timeline

• Start date: 2002-09-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2006-11-22
• Last updated: 2009-04-29

Locations

1 site across 1 country: United States