NCT00358176

Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

A Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Noninferiority Study Comparing 75mg Risedronate Dosed on 2 Consecutive Days Monthly With 5mg Daily Risedronate in the Treatment of Postmenopausal Osteoporosis as Assessed Over 24 Months.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,231 (actual)
• Sponsor: Sanofi · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis. To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption. To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.

Conditions

• Osteoporosis Postmenopausal

Interventions

Type	Name	Description
DRUG	Risedronate (HMR4003)

Timeline

• Start date: 2004-07-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2006-07-31
• Last updated: 2009-12-15

Locations

11 sites across 11 countries: United States, Argentina, Australia, Canada, Czechia, France, Lebanon, Poland, South Africa, Turkey (Türkiye), United Kingdom