Assessing the Efficacy of Romosozumab in Postmenopausal Osteoporosis: An Updated Systematic Review and Meta-analysis.

Abstract

Background: Postmenopausal osteoporosis is a prevalent condition characterized by increased bone turnover and reduced bone mass, leading to fragility fractures. Romosozumab, a monoclonal antibody targeting sclerostin, exhibits dual mechanisms of action by stimulating bone formation and inhibiting bone resorption.

Objective: This meta-analysis aimed to study the effects of romosozumab in postmenopausal women compared with other interventions, evaluating changes in bone mineral density (BMD), incidence of new vertebral fractures, bone biomarkers, and safety.

Methods: A systematic search was conducted using 3 databases. Randomized controlled trials evaluating romosozumab in postmenopausal patients with osteoporosis were included. The analyzed variables included BMD, the incidence of new vertebral fractures, markers of bone formation and resorption, and adverse events. Sensitivity analyses and GRADE (Grading of Recommendations Assessment, Development, and Evaluation) assessments were conducted to ensure the robustness and certainty of the finding.

Results: Ten randomized controlled trials with 15,476 patients were included. Romosozumab demonstrated significantly greater improvements in lumbar spine BMD than placebo (mean difference [MD], 13.18; 95% confidence interval [CI], 11.91-14.45; p < 0.00001), denosumab (MD, 5.29; 95% CI, 4.20-6.37; p < 0.00001), teriparatide (MD, 4.35; 95% CI, 4.09-4.61; p < 0.00001), and alendronate (MD, 9.95; 95% CI, 7.51-12.40; p < 0.00001). Romosozumab also showed higher levels of the bone formation marker P1NP (procollagen 1 N-terminal propeptide) than denosumab (standardized mean difference, 1.30; 95% CI, 0.38-2.21; participants = 178; studies = 2; I2 = 83%; p = 0.006) and alendronate (standardized mean difference, 2.06; 95% CI, 1.68-2.45; participants = 366; studies = 2; I2 = 46%; p < 0.00001). Romosozumab reduced the risk of vertebral fractures 4-fold versus placebo (odds ratio, 0.26; 95% CI, 0.13-0.53; participants = 3186; studies = 2; I2 = 0%; p = 0.0002). The present study has some limitations, including potential heterogeneity among the included trials and the need for long-term safety data. Nevertheless, the safety profile of romosozumab was comparable to the comparator interventions.

Conclusions: This comprehensive meta-analysis provides robust evidence that romosozumab is an effective and safe treatment option for postmenopausal osteoporosis, with superior effects on BMD and bone formation biomarkers compared with other interventions. These findings support the use of romosozumab to improve clinical outcomes in this patient population.