Cardiovascular safety of osteoanabolic agents

Several osteoanabolic agents have been developed to build new bone more efficiently than anti-resorptive drugs. Among them, romosozumab, an anti-sclerostin antibody, is a potent pharmacological tool to prevent fractures in osteoporosis patients. The efficacy of romosozumab in preventing osteoporotic fractures is robust. However, there remains a concern about increased cardiovascular (CV) adverse events related to romosozumab. Available data have been reviewed to address this concern.

Published articles on romosozumab of which pivotal randomized controlled trials (RCTs), meta-analyses of RCTs, pharmacovigilance investigations, and retrospective observational clinical studies using real-world data were collected through PubMed and other available tools.

Meta-analyses of RCTs of romosozumab compared to placebo and other anti-osteoporosis drugs have left room for controversy in the CV safety of romosozumab. Investigations of the real-world data also provide no conclusive evidence in this issue.

We need more robust evidence to establish an appropriate and reasonable guide to prescribe romosozumab in our clinical practice.