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A systematic review and meta-analysis of efficacy and safety of Romosozumab in postmenopausal osteoporosis

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Abstract

The study was conducted to illustrate the effect of Romosozumab in postmenopausal osteoporosis patients. Romosozumab decreased the incidence of vertebral, nonvertebral, and clinical fractures significantly. In addition, decreased incidence of falls and increased bone mineral density at lumbar spine, total hip, and femoral neck was observed. Romosozumab is a monoclonal antibody that acts against the sclerostin pathway leading to enhanced bone formation and reduced bone resorption in patients with osteoporosis. Electronic search was performed on Medline (via PubMed), The Cochrane Central Register of Controlled Trials, and clinicaltrials.gov, till May 2020, for RCTs evaluating the effectiveness of Romosozumab in postmenopausal osteoporosis. RCTs evaluating the effect of Romosozumab on fractures and bone mineral density in postmenopausal osteoporosis patients. Meta-analysis was performed by Cochrane review manager 5 (RevMan) version 5.3. Cochrane risk of bias 2.0 tool and GRADE pro-GDT were applied for methodological quality and overall evidence quality, respectively. One hundred seventy-nine studies were screened, and 10 eligible studies were included in the analysis, with a total of 6137 patients in romosozumab group and 5732 patients in control group. Romosozumab significantly reduced the incidence of vertebral fractures [OR = 0.43 (95%CI = 0.35–0.52), High-quality evidence], nonvertebral fractures [OR = 0.78 (95%CI = 0.66–0.92), High quality], and clinical fractures [OR = 0.70 (95%CI = 0.60–0.82), High quality] at 24 months. Significant reduction in incidence risk of falls [OR = 0.87 (95%CI = 0.78–0.96), High quality] was observed with romosozumab. Bone mineral density was significantly increased in the romosozumab treated groups at lumbar spine [MD = 12.66 (95%CI = 12.66–12.67), High quality], total hip [MD = 5.69 (95%CI = 5.68 – 5.69), Moderate quality], and femoral neck [MD = 5.18 (95%CI = 5.18–5.19), Moderate quality] at 12 months. The total adverse events [RR = 0.98(95%CI = 0.96–1.01), Moderate quality] and serious adverse events [RR = 0.98(95%CI = 0.88–1.08), Moderate quality] with romosozumab were comparable to the control group. The current analysis with evidence on efficacy and safety of Romosozumab, authors opine to recommend the use of Romosozumab treatment for post-menopausal osteoporosis.

Systematic review registration: PROSPERO registration number: CRD42019112196

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Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author on request.

Abbreviations

BPs:

Bisphosphonates

PRISMA:

Preferred Reporting Items for Systematic Reviews and Meta-Analyses

PROSPERO:

International Prospective Register of Systematic Reviews

ROMO:

Romosozumab

ROB-2:

The Risk of Bias -2 tool for randomized control trials

CI:

Confidence interval

OR:

Odd ratios

HR:

Hazard ratios

GRADE pro GDT:

Grades of Recommendations, Assessment, Development and Evaluations (GRADE) guideline development tool

OIS:

Optimal information size

vs:

Versus

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Acknowledgements

We acknowledge GRADE Pro team [McMaster University and Evidence Prime Inc. available from: https://gradepro.org/] for letting us use the software for the synthesis and overall assessment and grading of systematic review.

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Authors

Contributions

Study design and planning of systematic review—All of the authors

Literature search—SD, SS

Figures—SS, SD, SK

Tables—JS, SK, SS

Data collection and analysis—SS, SBV

ROB—SD, SS, Query resolved by all authors

GRADE Analysis—SS Query resolved by all authors

Data interpretation—SS, SD, SK

Writing—SS, SD, TK

Corrections and Final approval of Manuscript—All of the authors

The corresponding author attests that all listed authors meet authorship criteria as per ICJME and that the manuscript is an honest, accurate, and transparent account of the study being reported.

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Correspondence to S. Dutta.

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Singh, S., Dutta, S., Khasbage, S. et al. A systematic review and meta-analysis of efficacy and safety of Romosozumab in postmenopausal osteoporosis. Osteoporos Int 33, 1–12 (2022). https://doi.org/10.1007/s00198-021-06095-y

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