Mäkinen V-N, Sølling A S, McClung M, Langdahl B L
Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.
Oregon Osteoporosis Center, Portland, OR, USA.
J Endocrinol Invest. 2025 Mar;48(3):547-572. doi: 10.1007/s40618-024-02469-1. Epub 2024 Nov 2.
Romosozumab, a new treatment of osteoporosis, is a monoclonal antibody that targets sclerostin and thereby exhibits a dual mechanism of action by stimulating bone formation and inhibiting bone resorption. This systematic review aims to assess the clinical efficacy and safety of romosozumab for treatment of primary and secondary osteoporosis.
A comprehensive literature search was conducted in October 2023 across multiple databases including Embase, PubMed and Cochrane Library. Randomized controlled trials (RCTs) and observational studies evaluating the impact of romosozumab on BMD, bone turnover markers (BTM), fracture outcomes, and its safety profile were included. Data extraction and quality assessment were performed independently by two reviewers in accordance with PRISMA guidelines.
A total of 36 articles met the inclusion criteria. Romosozumab significantly increased BMD at the lumbar spine, total hip, and femoral neck compared to placebo and active comparators in patients with primary osteoporosis. Sequential therapy with romosozumab followed by antiresorptives maintained or further increased BMD and reduced fracture risk. Romosozumab was generally well tolerated, however, an imbalance in cardiovascular adverse event was observed in one large clinical trial. Observational studies supported these findings. Specific subgroups of patients with secondary osteoporosis were assessed, demonstrating overall positive outcomes with romosozumab treatment.
Romosozumab effectively increases BMD and reduces fracture risk, particularly when used as initial therapy in high fracture-risk patients. Sequential therapy with subsequent antiresorptive treatment optimizes long-term benefits. While generally well-tolerated, its cardiovascular safety profile requires further long-term studies to ensure its safety in clinical practice. Additional studies are needed to confirm efficacy and safety in patients with secondary osteoporosis.
罗莫佐单抗是一种治疗骨质疏松症的新药，它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展现出双重作用机制。本系统评价旨在评估罗莫佐单抗治疗原发性和继发性骨质疏松症的临床疗效和安全性。
2023年10月在多个数据库（包括Embase、PubMed和Cochrane图书馆）进行了全面的文献检索。纳入评估罗莫佐单抗对骨密度、骨转换标志物（BTM）、骨折结局及其安全性影响的随机对照试验（RCT）和观察性研究。两名评价者按照PRISMA指南独立进行数据提取和质量评估。
共有36篇文章符合纳入标准。在原发性骨质疏松症患者中，与安慰剂和活性对照药相比，罗莫佐单抗显著提高了腰椎、全髋和股骨颈的骨密度。罗莫佐单抗序贯抗吸收药物治疗可维持或进一步提高骨密度并降低骨折风险。罗莫佐单抗总体耐受性良好，然而，在一项大型临床试验中观察到心血管不良事件存在失衡。观察性研究支持了这些发现。对继发性骨质疏松症患者的特定亚组进行了评估，结果显示罗莫佐单抗治疗总体呈阳性。
罗莫佐单抗可有效提高骨密度并降低骨折风险，尤其是在高骨折风险患者中用作初始治疗时。后续抗吸收治疗的序贯疗法可优化长期获益。虽然总体耐受性良好，但其心血管安全性需要进一步的长期研究以确保其在临床实践中的安全性。需要更多研究来证实其在继发性骨质疏松症患者中的疗效和安全性。
