NCT00980174

Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Compare the Efficacy and Safety of Denosumab Versus Placebo in Males With Low Bone Mineral Density

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Amgen · Industry
• Sex: Male
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess how effective and safe denosumab is in a population of males with low bone mass at risk of fracture. The primary clinical hypothesis is that in men with low bone mineral density, the mean percent change in lumbar spine bone mineral density at 12 months in subjects receiving denosumab will be greater than in subjects receiving placebo. Denosumab is a fully human monoclonal antibody with a high affinity for Receptor Activator of Nuclear Factor (RANK) Ligand that can bind and neutralize the activity of human RANK Ligand similar to the action of endogenous osteoprotegerin.

Conditions

• Low Bone Mass
• Low Bone Mineral Density
• Males With Osteoporosis
• Osteopenia
• Osteoporosis

Interventions

Type	Name	Description
DRUG	60 mg denosumab	60 mg denosumab (SC injection every 6 months)
OTHER	Placebo	Placebo for denosumab (SC injection every 6 months)

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-06-21
• Completion: 2012-05-23
• First posted: 2009-09-18
• Last updated: 2018-10-17
• Results posted: 2012-11-29