A Double-blind Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis (BRIDGE)

This is a phase 3 multicenter study to compare the efficacy and safety of Romosozumab (AMG 785) with placebo in men with osteoporosis.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab (AMG 785) With Placebo in Men With Osteoporosis
Enrollment: 245
Study Start Date: June 2014
Estimated Study Completion Date: April 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Arms:
- Active Comparator: AMG 785
- Placebo Comparator: Placebo