Aim: To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the safety and efficacy of romosozumab in the treatment of postmenopausal osteoporosis.
Method: A comprehensive literature review was performed of PubMed, EMBASE, Cochrane Controlled Trials Registry, and Web of Science for RCTs. Outcome measures were changes in lumbar spine, total hip and femoral neck bone mineral density (BMD), incidence of fractures and adverse events. Six trials were finally included.
Results: Romosozumab resulted in a significantly lower risk of new vertebral fracture (relative risk (RR) 0.37, 95% confidence interval (CI) 0.18-0.77, p = 0.005, n = 5371), non-vertebral fracture (RR 0.78, 95% CI 0.66-0.92, p < 0.0001, n = 5635) and hip fracture (RR 0.59, 95% CI 0.44-0.79, p = 0.0004, n = 5635) compared with other therapies. The BMD was significantly increased at the lumbar spine (weighted mean difference (WMD) 13.33, 95% CI 11.41-15.25, p < 0.00001, n = 198), total hip (WMD 5.09, 95% CI 3.81-6.38, p < 0.00001, n = 184) and femoral neck (WMD 4.70, 95% CI 3.50-5.90, p < 0.00001, n = 175) compared with placebo. There was no significant difference in the incidence of adverse events in patients with romosozumab compared to other therapies (RR 1.00, 95% CI 0.98-1.02).
Conclusion: In postmenopausal women with osteoporosis who were at high risk for fracture, romosozumab treatment resulted in a significantly lower risk of fracture. Romosozumab 210 mg monthly showed the largest gains in BMD, and was generally well tolerated.
Keywords: Romosozumab; meta-analysis; osteoporosis.