It has been estimated that over 2 million US men have osteoporosis, and another 12 million may be at risk. While morbidity risks from fracture remain significant, and despite updated guidelines from the Endocrine Society, osteoporosis remains an under-treated and under-evaluated in most men. Bisphosphonates remain the predominant therapy for treatment of osteoporosis with the best evidence to minimize fracture risk.
A recent placebo-controlled, phase 3 study sought to investigate the efficacy and safety of denosumab 60mg given every 6 months versus placebo in men with known low bone mineral density (BMD). After 12 months of therapy, 228 men who received denosumab were found to have BMD increases of 5.7% in the lumbar spine and 2.4% in the total hip. Clinical fractures occurred in only 2 (1.7%) and 1 (0.8%) of men in the placebo- and denosumab-treated groups, respectively. There were no reported adverse events of hypocalcemia, and sensitivity reactions occurred in only 3.5% of men.
This study concludes that 60mg of denosumab is similarly effective in men with low BMD, as it has been proven to be efficacious in post-menopausal women as well. The effects of improvement in BMD in this study were independent of gonadal function level, baseline BMD status, age, or estimated fracture risk.
Reference: Orwoli E, Teglbjaerg CS, Langdahl BL, et al. A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density. J Clin Endocrinol Metab 2012;97:3161-3169.