Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis
Status:
Completed
Trial end date:
2012-05-23
Target enrollment:
Participant gender:
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.