Kaveh Sara, Hosseinifard Hossein, Ghadimi Nashmil, Vojdanian Mahdi, Aryankhesal Aidin
Health Management and Economics Research Center, Iran University of Medical Sciences, Tehran, Iran.
Network of Immunity in Infection, Malignancy and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.
Clin Rheumatol. 2020 Nov;39(11):3261-3276. doi: 10.1007/s10067-020-04948-1. Epub 2020 May 8.
Osteoporosis is a chronic skeletal disease with an increasing prevalence. Romosozumab, as a monoclonal anti-sclerostin antibody with a dual function, has been produced. In this meta-analysis, we aimed to examine the efficacy of Romosozumab in patients with low bone mineral density. A systematic search was conducted in the most important electronic search engines like Cochrane Library, PubMed, Web of Science, Scopus, Google Scholar, and ClinicalTrials.gov at the end of July 2019 to retrieve randomized controlled trials (RCTs), which evaluated the effect of Romosozumab in patients with osteoporosis and/or low bone mineral density. After evaluating the quality of articles with the Cochrane checklist, data related to the outcomes of bone mineral density (BMD) of lumbar spine, femoral neck, and total hip, risk of clinical, vertebral and non-vertebral fractures, and risk of adverse events were extracted. Quality of evidence was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Heterogeneity between studies was evaluated by I2 and Q statistics. The meta-analysis was performed using CMA v.2.0 software. Of all the 671 initially retrieved articles, seven articles were entered into the meta-analysis after removing duplicates and reviewing papers with inclusion and exclusion criteria. The results of the meta-analysis showed that Romosozumab 210, 140, and 70 mg compared with Alendronate, Teriparatide, and placebo can increase the bone mineral density in the lumbar spine, femoral neck, and total hip. The risk of adverse events like adjudicated cardiovascular serious adverse events and adjudicated cardiovascular death was more in Romosozumab 210 mg in comparison with placebo. However, this difference was not statistically significant. Treatment with anti-sclerostin antibodies can be a proper therapeutic option in patients with osteoporosis and low bone mineral density. Based on the results of this meta-analysis, it seems that Romosozumab, with its dual function, has a positive role in the treatment of osteoporosis and low bone mineral density.
骨质疏松症是一种患病率不断上升的慢性骨骼疾病。已研发出一种具有双重功能的单克隆抗硬化素抗体——罗莫单抗。在这项荟萃分析中，我们旨在研究罗莫单抗对低骨密度患者的疗效。2019年7月底，我们在Cochrane图书馆、PubMed、科学网、Scopus、谷歌学术和ClinicalTrials.gov等最重要的电子搜索引擎中进行了系统检索，以获取评估罗莫单抗对骨质疏松症和/或低骨密度患者疗效的随机对照试验（RCT）。使用Cochrane清单评估文章质量后，提取了与腰椎、股骨颈和全髋部骨密度（BMD）结果、临床骨折、椎体骨折和非椎体骨折风险以及不良事件风险相关的数据。根据推荐分级评估、制定和评价（GRADE）方法评估证据质量。通过I²和Q统计量评估研究之间的异质性。使用CMA v.2.0软件进行荟萃分析。在最初检索到的671篇文章中，经过去除重复项并根据纳入和排除标准审阅论文后，有7篇文章纳入荟萃分析。荟萃分析结果表明，与阿仑膦酸钠、特立帕肽和安慰剂相比，210、140和70毫克的罗莫单抗可增加腰椎、股骨颈和全髋部的骨密度。与安慰剂相比，210毫克罗莫单抗发生经判定的心血管严重不良事件和经判定的心血管死亡等不良事件的风险更高。然而，这种差异无统计学意义。抗硬化素抗体治疗可能是骨质疏松症和低骨密度患者的一种合适治疗选择。基于这项荟萃分析的结果，似乎具有双重功能的罗莫单抗在骨质疏松症和低骨密度的治疗中具有积极作用。
