Conditions: Low Bone Mass Low Bone Mineral Density Males With Osteoporosis Osteopenia Osteoporosis
Keywords: men male denosumab BMD lumbar spine ADAMO The ADAMO Trial male osteoporosis osteoporosis in men males with low bone mineral density
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 242
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Subjects will receive placebo for denosumab (SC injection every 6 months) for 1 year (double-blind phase) followed by 60 mg denosumab (SC injection every 6 months) for 1 year (open-label phase) arm 2: 60 mg denosumab (SC injection every 6 months) for 1 year (double-blind phase) followed by 60 mg denosumab(SC injection every 6 months) for 1 year (open-label phase). These subjects will be on denosumab for a total of 2 years.

Interventions: intervention 1: 60 mg denosumab intervention 2: Placebo
Intervention descriptions: intervention 1: 60 mg denosumab (SC injection every 6 months) intervention 2: Placebo for denosumab (SC injection every 6 months)

Protocol document: