Effects of Romosozumab on Bone Mineral Density and Fractures; a Univariate Meta Analysis

Abstract

Abstract Purpose Romosozumab, a monoclonal antibody has been approved for the treatment of postmenopausal women with osteoporosis and high fracture risk. This meta-analysis evaluated the effect of romosozumab on Bone Mineral Density (BMD) and fracture occurrence in postmenopausal women with osteoporosis. Methods A systematic search was done adhered to the PRISMA guidelines in PubMed, Ovid and Clinicaltrials.gov and eligible studies were selected. In addition to details related to study participants, changes in BMD at the lumber spine (LS), total hip (TH) and femoral neck (FN) and the occurrence of fractures during the study period were extracted. The mean differences of BMDs between the two study groups and odds ratios (OR) of fractures were considered as the outcome of studies. Results Of the 11 potentially eligible articles, four were included in the meta-analysis. Romosozumab therapy for 12 months increased mean BMD at the LS by 12.7% (95% CI, 9.7, 15.6), TH by 4.8% (95% CI, 3.3,6.3) and FN by 4.3% (95% CI, 3.1, 5.5). Treatment with romosozumab was associated with 54% and 25% reduction of new vertebral (OR = 0.46, CI, 0.23,0.91) and non-vertebral fractures (OR = 0.75, CI, 0.53,1.06) respectively at the end of 12months. Conclusion In conclusion, romosozumab significantly increases BMD at LS, TH and FN and reduces the risk of new vertebral and non-vertebral fractures in postmenopausal women with osteoporosis.