Resumo do estudo

Two hundred and twenty-eight men with osteoporosis were randomized to receive 12 months of daily subcutaneous abaloparatide (n=149) or placebo (n=79). The primary outcome of interest was the change from baseline in lumbar spine bone mineral density (BMD). Secondary outcomes of interest include BMD of the femoral neck and hip and the incidence of new clinical fractures; safety outcomes were also assessed. The change from baseline in BMD of the lumbar spine, hip and femoral neck were all significantly greater in the abaloparatide group at all time points. No differences in the incidence of treatment-emergent adverse events (TEAEs) or serious TEAEs were observed between the two groups. 1 fracture in the abaloparatide group & 3 fractures in the control group were reported. In summary, abaloparatide significantly improved bone mineral density, with no marked increase in adverse events, suggesting it is an effective treatment for osteoporosis in men.