Risk of falls in postmenopausal women treated with romosozumab: Preliminary indices from a meta-analysis of randomized, controlled trials

OBJECTIVES: Falls are the well-known risk factor for osteoporotic fractures and some medications can increase the risk of falls. Therefore, the aim of our study is to evaluate the effect of romosozumab on risk of falls in postmenopausal women. METHODS: Studies were searched on PubMed, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov using the search term “romosozumab.” Randomized, clinical trials with romosozumab in postmenopausal women, which met the inclusion criteria and in particular reported on falls in safety or efficacy data, were included into the meta-analysis. Risk ratios (RRs) and corresponding 95% confidence intervals (CIs) were calculated using a binary effects model. RESULTS: A total of four studies with overall 12,128 postmenopausal women with osteoporosis were included into the meta-analysis. Twelve-months treatment with romosozumab reduced the risk of falls nonsignificantly by 16% (RR, 0.84; 95% CI, 0.67–1.04; P = 0.10; n = 11,829). A subgroup analysis with double-blind studies indicated a statistically significant reduction in risk of falls by 20% (RR, 0.80; 95% CI, 0.71–0.92; P ≤ 0.01; n = 11,211). A sequential treatment of romosozumab followed by an antiresorptive medication resulted in a 12% (RR, 0.88; 95% CI, 0.80–0.96; P ≤ 0.01; n = 11,211) reduction of falls in the romosozumab group compared to the control group. CONCLUSIONS: This analysis indicates that romosozumab has a tendency to reduce risk of falls in postmenopausal women with osteoporosis. Nevertheless, our findings are preliminary results with a low significance and to confirm these findings more data and analyses are needed.