Safety of Romosozumab in Osteoporotic Men and Postmenopausal Women: A Meta-Analysis and Systematic Review

Sclerostin is a protein synthesized mainly by osteocytes whose function is to inhibit bone formation. A recent monoclonal antibody, Romosozumab, is able to block sclerostin. The aim of this meta-analysis is to compare the safety of Romosozumab with placebo and alendronate. Five randomized controlled trials that described the safety of Romosozumab in healthy men and postmenopausal women were analyzed. The measures to be compared were the number of adverse events and the number of serious adverse events. Specific results included injection site reaction, arthralgia, nasopharyngitis, and back pain. A total of 11,741 patients were included in this meta-analysis, in three different groups: Romosozumab, alendronate, and placebo. Significant differences were seen between the groups with regard to injection site reaction: 5.88% in the Romosozumab group versus 3.62% in the placebo group (Mantel-Haenszel [M-H] 1.54, confidence interval [95% CI] 1.22-1.96; p < 0.001) and 2.62% in the alendronate group (M-H 1.8, 95% CI 1.32-2.60; p < 0.001). In addition, patients treated with Romosozumab had significantly fewer total adverse events than the alendronate group (M-H 0.85, 95% CI 0.74-0.98; p < 0.05). In conclusion, Romosozumab may have lower adverse effects compared to alendronate and comparable to a placebo, except injection site reactions. Injection site reactions were more with romosozumab compared to alendronate and compared to the placebo as well. Romosozumab appears to have a similar safety profile to bisphosphonates.