Ferrer Bartolomé Lladó, Garcia Marina Soledad Moreno, Herrera Sara Rojas, Dubuc César Antonio Egües, Mariscal Gonzalo, Mateu Juan Buades
From the Hospital Son Llatzer, Palma de Mallorca.
Hospital Universitario Miguel Servet, Zaragoza.
J Clin Rheumatol. 2025 Sep 1;31(6):e119-e127. doi: 10.1097/RHU.0000000000002241. Epub 2025 May 5.
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.
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.
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.
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.
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.
绝经后骨质疏松症是一种常见病症，其特征为骨转换增加和骨量减少，进而导致脆性骨折。罗莫佐单抗是一种靶向硬化蛋白的单克隆抗体，通过刺激骨形成和抑制骨吸收发挥双重作用机制。
本荟萃分析旨在研究与其他干预措施相比，罗莫佐单抗对绝经后女性的影响，评估骨密度（BMD）变化、新发椎体骨折发生率、骨生物标志物及安全性。
使用3个数据库进行系统检索。纳入评估罗莫佐单抗在绝经后骨质疏松症患者中的随机对照试验。分析变量包括BMD、新发椎体骨折发生率、骨形成和骨吸收标志物以及不良事件。进行敏感性分析和GRADE（推荐分级评估、制定与评价）评估，以确保研究结果的稳健性和确定性。
纳入10项随机对照试验，共15476例患者。与安慰剂相比，罗莫佐单抗显著提高腰椎BMD（平均差值[MD]，13.18；95%置信区间[CI]，11.91 - 14.45；p < 0.00001）、地诺单抗（MD，5.29；95% CI，4.20 - 6.37；p < 0.00001）、特立帕肽（MD，4.35；95% CI，4.09 - 4.61；p < 0.00001）和阿仑膦酸钠（MD，9.95；95% CI，7.51 - 12.40；p < 0.00001）。与地诺单抗相比，罗莫佐单抗的骨形成标志物P1NP（I型前胶原N端前肽）水平也更高（标准化平均差值，1.30；95% CI，0.38 - 2.21；参与者 = 178；研究 = 2；I² = 83%；p = 0.006），与阿仑膦酸钠相比也更高（标准化平均差值，2.06；95% CI，1.68 - 2.45；参与者 = 366；研究 = 2；I² = 46%；p < 0.00001）。与安慰剂相比，罗莫佐单抗使椎体骨折风险降低4倍（比值比，0.26；95% CI，0.13 - 0.53；参与者 = 3186；研究 = 2；I² = 0%；p = 0.0002）。本研究存在一些局限性，包括纳入试验间可能存在的异质性以及对长期安全性数据的需求。尽管如此，罗莫佐单抗的安全性与对照干预措施相当。
这项全面的荟萃分析提供了有力证据，表明罗莫佐单抗是绝经后骨质疏松症的一种有效且安全的治疗选择，与其他干预措施相比，对BMD和骨形成生物标志物具有更优效果。这些发现支持使用罗莫佐单抗改善该患者群体的临床结局。
