NCT00353080

Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

A Two-year, Multicenter, Double-blind, Randomized, Placebo-controlled and Parallel Group Study of Oral Risedronate 5 mg Daily in the Prevention of Osteoporosis in Osteopenic Postmenopausal Women (More Than 5 Years Postmenopausal)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Sanofi · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption To confirm general safety of 5 mg daily risedronate as compared to placebo

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	risedronate (HMR4003)

Timeline

• Start date: 2002-12-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2006-07-17
• Last updated: 2009-12-15

Locations

5 sites across 5 countries: Finland, Netherlands, Norway, Spain, Sweden