中国组织工程研究

中国组织工程研究 ›› 2026, Vol. 30 ›› Issue (35): 9294-9301.doi: 10.12307/2026.469

• 组织构建循证医学 evidence-based medicine in tissue construction • 上一篇    下一篇

罗莫佐单抗治疗成年人骨质疏松症有效性和安全性的Meta分析

王晓晨1，郭  林1，王常成2，徐  坦3，谷明西3   

  1. 1大连大学附属中山医院骨科，辽宁省大连市   116001；2大连理工大学医学部，辽宁省大连市   116001；3北京大学深圳医院，广东省深圳市   518000 

  • 收稿日期:2025-10-29 修回日期:2026-02-15 出版日期:2026-12-18 发布日期:2026-04-29
  • 通讯作者: 谷明西，硕士，医师，北京大学深圳医院，广东省深圳市 518000
  • 作者简介:王晓晨，辽宁省大连市人，汉族，主要从事髋膝关节置换术后康复方面的研究。

Efficacy and safety of romozumab in the treatment of osteoporosis in adults: a meta-analysis

Wang Xiaochen1, Guo Lin1, Wang Changcheng2, Xu Tan3, Gu Mingxi3   

  1. 1Department of Orthopedics, Zhongshan Hospital of Dalian University, Dalian 116001, Liaoning Province, China; 2Medical Department of Dalian University of Technology, Dalian 116001, Liaoning Province, China; 3Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China
  • Received:2025-10-29 Revised:2026-02-15 Online:2026-12-18 Published:2026-04-29
  • Contact: Gu Mingxi, MS, Physician, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China
  • About author:Wang Xiaochen, Department of Orthopedics, Zhongshan Hospital of Dalian University, Dalian 116001, Liaoning Province, China

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摘要：



文题释义：
骨质疏松症：是一种以骨量低下、骨组织微结构损坏，导致骨脆性增加、骨折风险剧增为特征的全身性骨骼疾病，它通常发生在老年人身上，尤其是绝经后妇女。
罗莫佐单抗：是硬骨素的单克隆抗体，能够与硬骨素靶向结合，从而减少硬骨素对Wnt信号通路的影响，从而增加成骨、抑制破骨，起到双重机制治疗骨质疏松的目的。

目的：罗莫佐单抗(Romosozumab)是一种新型生物制剂，正被应用于治疗骨折高风险绝经后女性骨质疏松症。此项Meta分析旨在系统评估罗莫佐单抗与安慰剂、阿仑膦酸钠、特立帕肽和地舒单抗在治疗成年人骨质疏松症方面的有效性和安全性。
方法：使用医学关键词“anti-sclerostin antibody，romosozumab，AMG 78500，罗莫佐单抗，osteoporosis”在PubMed、中国知网、Web of Science数据库和Cochrane对照试验中央注册中心(CENTRAL)检索从建库至2025-07-01之前发布的比较罗莫佐单抗与阿仑膦酸钠、特立帕肽、地舒单抗或安慰剂治疗成人骨质疏松症安全性和有效性的随机对照试验。由2名研究人员独立检索筛选符合纳入条件的研究，评估偏倚风险，并提取了每项研究的数据，采用Cochrane协作网的随机对照试验偏倚风险评估工具对随机对照试验进行质量评价，使用综述管理软件(RevMan 5.4版)进行Meta分析。评估抗骨质疏松治疗效果的主要指标是干预6，12个月时骨密度与基线百分比的变化；次要指标是使用抗骨质疏松药物治疗期间不良事件和心血管并发症发生率。
结果：①共有10项随机对照试验、12 570例患者纳入Meta分析；②与安慰剂、阿仑膦酸钠、特立帕肽相比，罗莫佐单抗可显著增加在6，12个月时腰椎、全髋关节和股骨颈的骨矿物质密度；与地舒单抗相比，罗莫佐单抗可显著增加在6，12个月时的腰椎骨矿物质密度(MD=3.68，95%CI：0.34-7.01，P=0.03；MD=5.20，95%CI：3.19-7.21，P < 0.000 01)，而在6，12个月时两者的全髋关节、股骨颈骨密度无显著性差异；③在安全性方面，与阿仑膦酸钠组相比，罗莫佐单抗的不良事件发生率较低(RR=0.96，95%CI：0.93-0.99，P=0.02)；与特立帕肽组相比，罗莫佐单抗的不良事件发生率较高(RR=1.13，95%CI：1.01-1.25，P=0.03)；罗莫佐单抗与安慰剂、地诺单抗相比在不良事件发生率上无统计学差异(RR=0.98，95%CI：0.96-1.00，P=0.11；RR=2.64，95%CI：0.74-9.36，P=0.13)；④最重要的是与其他治疗方法相比，罗莫佐单抗未显著增加心血管并发症的发生风险(RR=1.25，95%CI：0.94-1.67，P=0.12)。
结论：罗莫佐单抗可快速改善腰椎骨密度，整体安全性可控，特别适用于需快速提升骨量的高骨折风险且无心血管禁忌的成年骨质疏松患者。此次Meta分析基于有限的数据，仍存在一定的局限性，还需要更多更高质量持续时间更长的随访研究验证结果。
https://orcid.org/0000-0001-7922-0564 (谷明西) 


中国组织工程研究杂志出版内容重点：干细胞；骨髓干细胞；造血干细胞；脂肪干细胞；肿瘤干细胞；胚胎干细胞；脐带脐血干细胞；干细胞诱导；干细胞分化；组织工程

关键词: 罗莫佐单抗, 骨质疏松症, 绝经, 心血管并发症, Meta分析

Abstract: OBJECTIVE: Romosozumab is a novel biologic agent currently being used to treat osteoporosis in postmenopausal women at high risk of fracture. This meta-analysis aims to systematically evaluate the efficacy and safety of romosozumab compared with placebo, alendronate sodium, teriparatide, and denosumab in the treatment of osteoporosis in adults.
METHODS: The medical keywords “anti-sclerostin antibody,” “romosozumab,” “AMG 78500,” and “osteoporosis” were used to search PubMed, CNKI, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL) for randomized controlled trials comparing the safety and efficacy of romosozumab with alendronate, teriparatide, denosumab, or placebo in adult patients with osteoporosis, published from database inception until July 1, 2025. Two researchers independently screened eligible studies, assessed the risk of bias, and extracted data from each study. The quality of the included randomized controlled trials was evaluated using the Cochrane Collaboration’s Risk of Bias Tool for Randomized Controlled Trials. Meta-analysis was performed using review management software (RevMan version 5.4). The primary outcome for assessing anti-osteoporotic efficacy was the percentage change in bone mineral density from baseline at 6 and 12 months. Secondary outcomes included the incidence of adverse events and cardiovascular complications during treatment with anti-osteoporotic medications.
RESULTS: (1) A total of 10 randomized controlled trials involving 12 570 patients were included in the meta-analysis. (2) Compared with placebo, alendronate, and teriparatide, romosozumab significantly increased bone mineral density at the lumbar spine, total hip, and femoral neck at 6 and 12 months. Compared with denosumab, romosozumab significantly increased lumbar spine bone mineral density at 6 months (mean difference [MD]=3.68, 95% confidence interval [CI]: 0.34–7.01, P=0.03) and 12 months (MD=5.20, 95% CI: 3.19–7.21, P < 0.000 01), while no significant differences were observed in total hip or femoral neck bone mineral density at 6 and 12 months between the two treatments. (3) In terms of safety, compared with the alendronate subgroup, romosozumab had a lower incidence of adverse events (relative risk [RR]=0.96, 95% CI: 0.93-0.99, P=0.02); compared with the teriparatide subgroup, romosozumab had a higher incidence of adverse events (RR=1.13, 95% CI: 1.01–1.25, P=0.03). There were no statistically significant differences in the incidence of adverse events between romosozumab and placebo (RR=0.98, 95% CI: 0.96–1.00, P=0.11) or denosumab (RR=2.64, 95% CI: 0.74–9.36, P=0.13). (4) Most importantly, romosozumab did not significantly increase the risk of cardiovascular complications compared with other treatments (RR=1.25, 95% CI: 0.94-1.67, P=0.12).
CONCLUSION: Romosozumab can rapidly improve lumbar spine bone mineral density with an overall controllable safety profile, making it particularly suitable for adult osteoporosis patients at high fracture risk who require rapid bone mass improvement and have no cardiovascular contraindications. This meta-analysis is based on limited data and has certain limitations. More high-quality, longer-term follow-up studies are needed to validate these findings.


Key words: romosozumab, osteoporosis, menopause, cardiovascular complications, meta-analysis

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