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

Ferrer BL, Garcia MSM, Herrera SR, Dubuc CAE, Mariscal G, Mateu JB

Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases, 2025

15,476 participants

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).…

How strong is the evidence?

Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 15,476 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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