– School of Pharmaceutical Education and Research, Jamia Hamdard, India
Background: Worldwide, osteoporosis in postmenopausal women remains a substantial public health burden. In postmenopausal women, normal bone turnover cycles are impaired, resulting in reduced bone mineral density (BMD) and increased risk of vertebral and non-vertebral fracture. Romosozumab has been indicated to be effective treatment and associated with increased BMD in postmenopausal women. However, the evidence of efficacy and safety of this new drug are not well documented.
Objectives: The objective of this study to estimate the effect of romosozumab on changes in BMD and incidence of new adverse events using meta-analytic approach.
Methods: A systematic search on MEDLINE, Cochrane library, Web of Science and Clinical trial.gov was performed to identify English language articles. The outcome measures were changes in lumbar spine, total hip and femoral neck bone mineral density (BMD), incidence of adverse events and fractures. A random effects model was used to calculate the weighted mean difference (WMD) and relative risks (RR) with 95% confidence interval (CI).
Results: A total of 10 RCTs were included in this metanalytic synthesis. Results from meta-analysis showed that BMD was significantly increased at the lumbar spine (WMD= 12.61, 95%CI 8.52-16.70, p< 0.00001), total hip (WMD= 3.71, 95%CI 2.42-5.01, p< 0.00001) and femoral neck (WMD= 3.21, 95%CI 1.75-4.68, p< 0.00001). There was also significant difference in increasing BMD at lumbar spine (WMD= 6.19, 95%CI 4.23-8.14, p< 0.00001), total hip (WMD= 3.15, 95%CI 2.66-3.64, p< 0.00001) and femoral neck (WMD= 3.08, 95%CI 2.59-3.57, p< 0.00001) in patients with romosozumab compared to other therapies (Teriparatide/Alendronate). Romosozumab significantly lower the risk of new vertebral and non-vertebral fracture compared with control group. Additionally, there was no significant difference in the incidence of overall adverse events in patients with romosozumab compared to placebo and other active treatment (RR 1.00, 95%CI 0.98-1.02, p< 0.94) and (RR 0.98, 95%CI 0.89-1.07, p< 0.64).
Conclusions: The current evidence suggests, romosozumab showed higher gains in BMD, and significantly lower the risk of fracture in postmenopausal women with osteoporosis. Further, RCTs are required to confirm the present findings.
