NCT00670319

Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,705 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

To study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	Raloxifene HCL	Raloxifene HCL 60 mg orally once daily
DRUG	Raloxifene HCL	Raloxifene HCL 120 mg orally once daily
DRUG	Placebo	Placebo one tab orally per day

Timeline

• Start date: 1994-11-01
• Primary completion: 1999-09-01
• Completion: 1999-09-01
• First posted: 2008-05-01
• Last updated: 2008-05-01

Locations

25 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Singapore, Slovakia, Slovenia, Spain, Sweden, United Kingdom