NCT01575834

Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,180 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Romosozumab	Administered by subcutaneous injection once a month (QM)
DRUG	Placebo	Administered by subcutaneous injection once a month (QM)
DRUG	Denosumab	Administered by subcutaneous injection once every 6 months (Q6M)

Timeline

• Start date: 2012-03-15
• Primary completion: 2015-12-14
• Completion: 2016-12-28
• First posted: 2012-04-12
• Last updated: 2024-08-28
• Results posted: 2018-11-08

Locations

218 sites across 24 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Colombia, Czechia, Denmark, Dominican Republic, Estonia, Germany, Hungary, India, Japan, Latvia, Lithuania, Mexico, New Zealand, Poland, Romania, Spain, Switzerland, United Kingdom