Romosozumab: a Review of Efficacy, Safety, and Cardiovascular Risk

Authors review the safety and efficacy of romosozumab for the treatment of osteoporosis as demonstrated in three phase III clinical trials and offer insights into the potential cardiovascular risk associated with its use.

Incidence of new vertebral fracture is dramatically reduced with 12 months of romosozumab use in comparison to both placebo and active bisphosphonate control groups in patients with postmenopausal osteoporosis. Significant non-vertebral anti-fracture benefit was also demonstrated in patients with more severe osteoporosis. Numerical increases in cardiovascular events call into question the safety of romosozumab use, particularly in patients with cardiovascular history or at high cardiovascular risk. Romosozumab has impressive anti-fracture effects in postmenopausal women with high risk for fragility fracture. Despite no significant differences in baseline cardiovascular risk factors between groups, a numerical increase in serious cardiovascular adverse events was demonstrated with romosozumab in randomized trials with no discernable etiology. Until more real-world evidence is available, romosozumab should not be used in patients with a recent cardiovascular event and should be used cautiously in patients with high cardiovascular risk. Romosozumab's place in therapy is likely patients with severe postmenopausal osteoporosis and low cardiovascular risk.