NCT01631214

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,093 (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 is effective in preventing fractures in women with postmenopausal osteoporosis.

Detailed description

In this trial, women were randomly assigned in a 1:1 ratio to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months. Randomization was stratified according to age (\<75 vs. ≥75 years). After completion of the double-blind treatment period, all the participants were to receive open-label weekly oral alendronate until the end of the trial, with blinding to the initial treatment assignment maintained. The primary analysis was performed when clinical fracture events had been confirmed in at least 330 participants and all the participants had completed the month 24 visit. The study was to continue in an event-driven manner until at least 440 participants experienced a nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral fractures at the primary analysis.

Conditions

• Postmenopausal Women With Osteoporosis

Interventions

Type	Name	Description
BIOLOGICAL	Romosozumab	Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.
DRUG	Alendronate	Alendronate 70 mg tablet taken once a week
DRUG	Placebo to Romosozumab	Administered by subcutaneous injection once a month during the double-blind treatment phase.
DRUG	Placebo to Alendronate	Matching placebo tablet taken once a week during the double-blind treatment phase.

Timeline

• Start date: 2012-05-04
• Primary completion: 2017-02-27
• Completion: 2017-06-29
• First posted: 2012-06-29
• Last updated: 2025-02-21
• Results posted: 2018-12-12

Locations

316 sites across 42 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom