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Efficacy and safety of Romosozumab in treatment for low bone mineral density: a systematic review and meta-analysis

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Abstract

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.

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Acknowledgments

The authors would like to thank Dr. Masoud Mozafari for facilitating this research and author collaborations. Moreover, we would like to express our gratitude to Dr. Bahareh Malmir, Ph.D in Applied Linguistics, who performed the language edition of the present article.

Funding

This research was supported by grant no. [Code: 31150–163–02-96] from Iran University of Medical Sciences.

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Authors and Affiliations

  1. Health Management and Economics Research Center, Iran University of Medical Sciences, Tehran, Iran

    Sara Kaveh, Nashmil Ghadimi & Aidin Aryankhesal

  2. Network of Immunity in Infection, Malignancy and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Tehran, Iran

    Sara Kaveh

  3. Research Center for Evidence Based Medicine (RCEBM), Tabriz University of Medical Sciences, Tabriz, Iran

    Hossein Hosseinifard

  4. Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran

    Mahdi Vojdanian

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  1. Sara Kaveh
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Correspondence to Aidin Aryankhesal.

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Kaveh, S., Hosseinifard, H., Ghadimi, N. et al. Efficacy and safety of Romosozumab in treatment for low bone mineral density: a systematic review and meta-analysis. Clin Rheumatol 39, 3261–3276 (2020). https://doi.org/10.1007/s10067-020-04948-1

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