Effects of romosozumab on low bone mineral density or osteoporosis in postmenopausal women: a systematic review

Osteoporosis is characterized by induced bone mass and deterioration of the skeletal microstructural, which weakens bone strength and adds the risk of fracture. Patients with osteoporosis treated with romosozumab has been indicated to be effective in postmenopausal women. This study aimed to systematically review the effect of romosozumab in postmenopausal women with low bone mineral density (BMD) or osteoporosis. PubMed, Cochrane library, and EMBASE databases were searched from the inception dates till March 12, 2019, using the keywords romosozumab, postmenopausal women, and osteoporosis to identify published RCTs meeting inclusion criteria. A narrative synthesis was conducted under specific headings according to the framework by the Economic Social and Research Council. Eight studies meeting the inclusion criteria were included. It was found that romosozumab significantly increased BMD from baseline compared with placebo. Almost all studies included showed that the bone resorption marker CTX decreased from baseline early. The BMD at the lumbar spine, femoral neck and total hip was increased in both romosozumab group and teriparatide at month 6 and 12. Common adverse events mainly involved neutralizing antibodies developed and injection site reactions. Compared with alendronate, teriparatide, and placebo, romosozumab enhanced BMD greater. In addition, romosozumab markedly increased the level of bone formation markers and sustainedly decreased the level of bone resorption markers. However, the cardiovascular effect was seriously adverse events for romosozumab and the incidence of adverse events with treatment of romosozumab was a bit higher than that with treatment of alendronate or teriparatide.