Efficacy and safety of odanacatib treatment for patients with osteoporosis: a meta-analysis.

The aim of this study was to evaluate the efficacy and safety of odanacatib (ODN) for the treatment of osteoporosis, using data in studies reported in the literature. We performed a literature search to compare the outcomes of applications of once-weekly ODN 50 mg and control. The outcomes of osteoporosis evaluated include primary outcome as bone mineral density (BMD) at different skeletal sites, and secondary outcomes, including adverse events (AEs), such as incidence of skin AEs, fracture, and serious adverse events (SAEs). Four trials were included. Mean difference (95% CI) of lumbar spine BMD was 3.41 (1.57-5.24) at 12 months and 4.89 (2.72-7.05) at 24 months; mean difference (95% CI) of femoral neck BMD was 1.90 (0.73-3.08) at 12 months and 3.85 (2.55-5.15) at 24 months; mean difference (95% CI) of total hip BMD was 2.65 (1.20-4.09) at 12 months and 3.70 (1.76-5.64) at 24 months; risk ratio (95% CI) of AEs was 0.98 (0.91-1.07); risk ratio (95% CI) of SAEs was 1.11 (0.72-1.72); risk ratio (95% CI) of skin AEs was 0.92 (0.63-1.35); and risk ratio (95% CI) of fracture was 0.34 (0.16-0.70). In this study, application of 50 mg ODN produced significantly greater BMD increases and lower fracture incidence than that of the control. In addition, ODN was generally well tolerated.