Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials

We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis.

PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated.

Six trials (7990 patients; follow-up period, 6–12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine 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) at 12 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.

Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions).