Chinese medical and pharmaceutical expert consensus on the clinical application of romosozumab

MO Liqian; CHEN Zefu; WU Huiyi; ZHENG Ping; ZHANG Zhongmin; LI Yilei

doi:10.6039/j.issn.1001-0408.2026.20.03

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Chinese medical and pharmaceutical expert consensus on the clinical application of romosozumab

更新时间：2026-10-29

- Chinese medical and pharmaceutical expert consensus on the clinical application of romosozumab
- ZHONGGUO YAOFANG Vol. 37, Issue 20, Pages: 2640-2646(2026)
- 作者机构：
  
  1.南方医科大学南方医院药学部，广州　510515
  2.南方医科大学南方医院脊柱骨科，广州　510515
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2026.20.03
  CLC： R969.3
- Received：06 August 2026，
  
  Revised：2026-09-11，
  
  Accepted：16 October 2026，
  
  Published：30 October 2026
- 稿件说明：
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莫立乾,陈泽夫,吴慧仪,等.罗莫索珠单抗临床应用中国医药专家共识 [J].中国药房,2026,37(20):2640-2646.

MO Liqian,CHEN Zefu,WU Huiyi,et al.Chinese medical and pharmaceutical expert consensus on the clinical application of romosozumab[J].ZHONGGUO YAOFANG,2026,37(20):2640-2646.
莫立乾,陈泽夫,吴慧仪,等.罗莫索珠单抗临床应用中国医药专家共识 [J].中国药房,2026,37(20):2640-2646. DOI： 10.6039/j.issn.1001-0408.2026.20.03.

MO Liqian,CHEN Zefu,WU Huiyi,et al.Chinese medical and pharmaceutical expert consensus on the clinical application of romosozumab[J].ZHONGGUO YAOFANG,2026,37(20):2640-2646. DOI： 10.6039/j.issn.1001-0408.2026.20.03.

摘要

目的

规范罗莫索珠单抗在我国临床的合理使用，明确适用人群，优化全程治疗策略并加强用药风险防控。

方法

本共识由广东省医院协会医院药事管理专业委员会发起，已完成国际实践指南注册。编写组组织国内药学、骨科领域的25名专家，通过2轮问卷调查与研讨会确定7个核心临床问题；系统检索中英文数据库，采用推荐分级的评估、制订与评价方法评价证据质量与推荐强度并形成共识建议，结合专家组意见修订完善。

结果

本共识最终形成7条推荐意见，涵盖罗莫索珠单抗的适用人群、序贯与转换药物治疗、用药期间骨折与心血管风险管理等内容，同时，归纳了罗莫索珠单抗的药学特征，以及疗效监测、漏用处理、禁忌证、主要不良反应及用药依从性等其他临床应用注意事项。

结论

本共识为罗莫索珠单抗在中国人群中的安全、有效、规范使用提供了科学依据与实践参考，有助于促进骨折高风险骨质疏松症患者的个体化治疗，降低骨折风险。

Abstract

OBJECTIVE

To standardize the rational clinical use of romosozumab in China， define suitable patient populations， optimize full-course treatment strategies， and strengthen medication risk management.

METHODS

This consensus was initiated by the Pharmacy Administration Committee of Guangdong Province Hospital Association and registered on the International Practice Guidelines Registry Platform. Twenty-five experts in pharmacy and orthopedics were organized to identify 7 core clinical questions through 2 rounds of questionnaires and seminars. Chinese and English databases were systematically retrieved， and the Grading of Recommendations Assessment， Development and Evaluation approach was used to assess evidence quality and recommendation strength and to formulate consensus recommendations， which were refined based on expert review.

RESULTS

Seven recommendations were developed， covering the applicable populations of romosozumab， sequential and switching therapy， and management of fractures and cardiovascular risk during treatment. The pharmaceutical characteristics of romosozumab， as well as other key points for clinical application， including efficacy monitoring， management of missed doses， contraindications， major adverse reactions， and medication adherence， were also summarized.

CONCLUSIONS

This consensus provides evidence-based guidance and practical reference for the safe， effective， and standardized use of romosozumab in Chinese patients， which may facilitate individualized treatment of patients with osteoporosis at high fracture risk and reduce fracture risk.

关键词

Keywords

references

中华医学会骨质疏松和骨矿盐疾病分会 . 原发性骨质疏松症诊疗指南：2022 [J ] . 中华骨质疏松和骨矿盐疾病杂志， 2022 ， 15 （ 6 ）： 573 - 611 .

Si L ， Winzenberg T M ， Jiang Q ， et al . Projection of osteoporosis-related fractures and costs in China：2010-2050 [J ] . Osteoporos Int ， 2015 ， 26 （ 7 ）： 1929 - 1937 .

Tanaka S ， Matsumoto T . Sclerostin：from bench to bedside [J ] . J Bone Miner Metab ， 2021 ， 39 （ 3 ）： 332 - 340 .

Cosman F ， Crittenden D B ， Adachi J D ， et al . Romosozumab treatment in postmenopausal women with osteoporosis [J ] . N Engl J Med ， 2016 ， 375 （ 16 ）： 1532 - 1543 .

Saag K G ， Petersen J ， Brandi M L ， et al . Romosozumab or alendronate for fracture prevention in women with osteoporosis [J ] . N Engl J Med ， 2017 ， 377 （ 15 ）： 1417 - 1427 .

Norris S L ， Gollogly L ， Penn C ， et al . WHO handbook for guideline development [M ] . 2nd ed . Geneva ： World Health Organization ， 2014 ： 109 - 121 .

Perel P . 17. The GRADE methodology for guideline development [J ] . Rheumatology ， 2014 ， 53 （ Suppl.2 ）： i9 - i10 .

《中国老年骨质疏松症诊疗指南》工作组，中国老年学和老年医学学会骨质疏松分会，中国医疗保健国际交流促进会骨质疏松病学分会，等 . 中国老年骨质疏松症诊疗指南：2023 [J ] . 中华骨与关节外科杂志， 2023 ， 16 （ 10 ）： 865 - 885 .

中华医学会骨科学分会 . 骨质疏松性骨折诊疗指南：2022年版 [J ] . 中华骨科杂志， 2022 ， 42 （ 22 ）： 1473 - 1491 .

Del Pino-Montes J ， Blanch J ， Nogués X ， et al . Expert consensus on the management of patients with postmenopausal osteoporosis in the Spanish healthcare system [J ] . Adv Ther ， 2016 ， 33 （ 4 ）： 658 - 669 .

Chandran M ， Mitchell P J ， Amphansap T ， et al . Development of the Asia Pacific Consortium on Osteoporosis（APCO）framework：clinical standards of care for the screening，diagnosis，and management of osteoporosis in the Asia-Pacific region [J ] . Osteoporos Int ， 2021 ， 32 （ 7 ）： 1249 - 1275 .

Loblaw D A ， Prestrud A A ， Somerfield M R ， et al . American Society of Clinical Oncology clinical practice guidelines：formal systematic review-based consensus methodology [J ] . J Clin Oncol ， 2012 ， 30 （ 25 ）： 3136 - 3140 .

Hohmann E ， Cote M P ， Brand J C . Research pearls：expert consensus based evidence using the Delphi method [J ] . Arthroscopy ， 2018 ， 34 （ 12 ）： 3278 - 3282 .

Rachner T D ， Hofbauer L C ， Göbel A ， et al . Novel therapies in osteoporosis：PTH-related peptide analogs and inhibitors of sclerostin [J ] . J Mol Endocrinol ， 2019 ， 62 （ 2 ）： R145 - R154 .

Wu D ， Li L ， Wen Z ， et al . Romosozumab in osteoporosis：yesterday，today and tomorrow [J ] . J Transl Med ， 2023 ， 21 （ 1 ）： 668 .

Padhi D ， Jang G ， Stouch B ， et al . Single-dose，placebo-controlled，randomized study of AMG 785，a sclerostin monoclonal antibody [J ] . J Bone Miner Res ， 2011 ， 26 （ 1 ）： 19 - 26 .

Liu Y ， Cao Y ， Zhang S ， et al . Romosozumab treatment in postmenopausal women with osteoporosis：a meta-analysis of randomized controlled trials [J ] . Climacteric ， 2018 ， 21 （ 2 ）： 189 - 195 .

广东省药品监督管理局 . 广东省卫生健康委员会关于发布粤港澳大湾区内地九市临床急需进口港澳药品医疗器械目录（2024年）的通告 [EB/OL ] .（ 2024-12-02 ）[ 2026-05-08 ] . https：//mpa.gd.gov.cn/xwdt/tzgg/content/post_4607465.html https://mpa.gd.gov.cn/xwdt/tzgg/content/post_4607465.html .

Lewiecki E M ， Blicharski T ， Goemaere S ， et al . A phase Ⅲ randomized placebo-controlled trial to evaluate efficacy and safety of romosozumab in men with osteoporosis [J ] . J Clin Endocrinol Metab ， 2018 ， 103 （ 9 ）： 3183 - 3193 .

McClung M R ， Brown J P ， Diez-Perez A ， et al . Effects of 24 months of treatment with romosozumab followed by 12 months of denosumab or placebo in postmenopausal women with low bone mineral density：a randomized，double-blind，phase 2，parallel group study [J ] . J Bone Miner Res ， 2018 ， 33 （ 8 ）： 1397 - 1406 .

Lewiecki E M ， Dinavahi R V ， Lazaretti-Castro M ， et al . One year of romosozumab followed by two years of denosumab maintains fracture risk reductions：results of the FRAME extension study [J ] . J Bone Miner Res ， 2019 ， 34 （ 3 ）： 419 - 428 .

Kobayakawa T ， Miyazaki A ， Takahashi J ， et al . Verification of efficacy and safety of ibandronate or denosumab for postmenopausal osteoporosis after 12-month treatment with romosozumab as sequential therapy：the prospective VICTOR study [J ] . Bone ， 2022 ， 162 ： 116480 .

Cosman F ， Libanati C ， Deignan C ， et al . Romosozumab followed by antiresorptive treatment increases the probability of achieving bone mineral density treatment goals [J ] . JBMR Plus ， 2021 ， 5 （ 11 ）： e10546 .

Langdahl B L ， Libanati C ， Crittenden D B ， et al . Romosozumab（sclerostin monoclonal antibody）versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy：a randomised，open-label，phase 3 trial [J ] . Lancet ， 2017 ， 390 （ 10102 ）： 1585 - 1594 .

Lane J ， Langdahl B ， Stone M ， et al . Romosozumab in patients who experienced an on-study fracture：post hoc analyses of the FRAME and ARCH phase 3 trials [J ] . Osteoporos Int ， 2024 ， 35 （ 7 ）： 1195 - 1204 .

Kobayakawa T ， Suzuki T ， Nakano M ， et al . Real-world effects and adverse events of romosozumab in Japanese osteoporotic patients：a prospective cohort study [J ] . Bone Rep ， 2021 ， 14 ： 101068 .

Smakaj A ， Tarantino U ， Iundusi R ， et al . Examining romosozumab adherence and side effects in osteoporotic patients after surgical fracture fixation：a comparative，descriptive，and hypothesis-generating study with non-fractured controls [J ] . Diseases ， 2025 ， 13 （ 5 ）： 148 .

Ishikawa K ， Tani S ， Toyone T ， et al . The potential effect of romosozumab on perioperative management for instrumentation surgery [J ] . Jor Spine ， 2024 ， 7 （ 3 ）： e1356 .

Conley R B ， Adib G ， Adler R A ， et al . Secondary fracture prevention：consensus clinical recommendations from a multistakeholder coalition [J ] . J Bone Miner Res ， 2020 ， 35 （ 1 ）： 36 - 52 .

中国药学会医院药学专业委员会，《骨质疏松症治疗药物合理建议用专家共识（2023）》编写组 . 骨质疏松症治疗药物合理建议用专家共识：2023 [J ] . 中国医院药学杂志， 2024 ， 44 （ 9 ）： 985 - 1006 .

Cheng L I ， Durden E ， Limone B ， et al . Persistance and compliance with osteroporosis therapies among women in a commercially insured population in the United States [J ] . J Manag Care Spec Pharm ， 2015 ， 21 （ 9 ）： 824 - 833 .

Rabenda V ， Reginster J Y . Overcoming problems with adherence to osteoporosis medication [J ] . Expert Rev Pharmacoecon Outcomes Res ， 2010 ， 10 （ 6 ）： 677 - 689 .

夏维波 . 开展“骨折联络服务”，减少再发骨折 [J ] . 中华骨质疏松和骨矿盐疾病杂志， 2016 ， 9 （ 1 ）： 1 - 6 .

Wong R M Y ， Ko S Y ， Chau W W ， et al . The first reported fracture liaison service（FLS）for vertebral fractures in China：is muscle the missing gap? [J ] . Arch Osteoporos ， 2021 ， 16 （ 1 ）： 168 .

Senay A ， Fernandes J C ， Delisle J ， et al . Persistence and compliance to osteoporosis therapy in a fracture liaison service：a prospective cohort study [J ] . Arch Osteoporos ， 2019 ， 14 （ 1 ）： 87 .

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