Romosozumab, a humanized monoclonal antibody sclerostin inhibitor, was FDA-approved in 2019 for the treatment of osteoporosis in postmenopausal women and men who are at increased risk of fracture. Significantly, the FDA applied a black box warning for the drug noting the potential risk of myocardial infarction, stroke and cardiovascular death.
Now, a research team from Saga University in Japan recently published a meta-analysis of 6 controlled clinical trials that looked at the efficacy and safety of romosozumab (210 mg, subcutaneously, 1x/month; Evenity®; Amgen) in 7990 patients with a follow-up period of 6–12 months. They looked at percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs), and calculated mean differences (MDs) with 95% confidence intervals (CIs).
Their findings show that compared to placebo, romosozumab significantly increased lumbar spine bone mineral density (BMD) (MD = 12.69; 95% CI 11.10-14.29), total hip BMD (MD = 4.42; 95% CI 3.03-5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42-5.57) at12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68-0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25-0.54), but increased injection-site reactions (RR = 1.83;95% CI 1.46-2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months.
They concluded that romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures and was generally well-tolerated, including the cardiovascular aspects. However, the occurrence of minor AEs (eg, injection-site reactions) should be considered.
Source: Kobayashi T, Hara M, Shimanoe C, et al. Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials. J Bone Miner Metab. 2024. https://doi.org/10.1007/s00774-024-01531-5.
