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Objective <p>The study aimed to assess whether a&#xa0;denosumab biosimilar is as effective and safe as the original denosumab for treating postmenopausal osteoporosis.</p> Methods <p>A&#xa0;comprehensive search of MEDLINE, Embase, and the Cochrane databases identified six randomized controlled trials (RCTs) relevant to this study. The meta-analysis focused on evaluating percentage changes in bone mineral density (BMD) at the lumbar spine, femoral neck, and total hip, alongside monitoring adverse events (AEs), serious adverse events (SAEs), and infections.</p> Results <p>The analysis encompassed 1784 patients, with 978 and 816 receiving biosimilar and originator therapy, respectively. Regarding standardized mean differences (SMDs) for BMD changes, a&#xa0;lumbar spine SMD of −0.048 (95% confidence interval [CI]: −0.142 to 0.046; <i>P</i> = 0.317), femoral neck SMD of 0.089 (95% CI: −0.068 to 0.247; <i>P</i> = 0.266), and total hip SMD of 0.029 (95% CI: −0.153 to 0.212; <i>P</i> = 0.755) were found, showing no significant differences between the two treatments. Safety profiles were also comparable, with odds ratios (ORs) of 1.168 (95% CI: 0.795–1.716; <i>P</i> = 0.428) for AEs, 1.120 (95% CI: 0.644–1.946; <i>P</i> = 0.689) for SAEs, and 1.576 (95% CI: 0.657–3.780; <i>P</i> = 0.308) for infections.</p> Conclusion <p>The denosumab biosimilars demonstrated efficacy and safety profiles comparable to the originator in the treatment of postmenopausal osteoporosis.</p>

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Comparative efficacy and safety of denosumab biosimilar and originator in postmenopausal osteoporosis: a meta-analysis of randomized controlled trials

  • 期刊论文

  • 发表日期：

    2025年9月24日

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  • Young Ho Lee,
  • Gwan Gyu Song

摘要

Objective

The study aimed to assess whether a denosumab biosimilar is as effective and safe as the original denosumab for treating postmenopausal osteoporosis.

Methods

A comprehensive search of MEDLINE, Embase, and the Cochrane databases identified six randomized controlled trials (RCTs) relevant to this study. The meta-analysis focused on evaluating percentage changes in bone mineral density (BMD) at the lumbar spine, femoral neck, and total hip, alongside monitoring adverse events (AEs), serious adverse events (SAEs), and infections.

Results

The analysis encompassed 1784 patients, with 978 and 816 receiving biosimilar and originator therapy, respectively. Regarding standardized mean differences (SMDs) for BMD changes, a lumbar spine SMD of −0.048 (95% confidence interval [CI]: −0.142 to 0.046; P = 0.317), femoral neck SMD of 0.089 (95% CI: −0.068 to 0.247; P = 0.266), and total hip SMD of 0.029 (95% CI: −0.153 to 0.212; P = 0.755) were found, showing no significant differences between the two treatments. Safety profiles were also comparable, with odds ratios (ORs) of 1.168 (95% CI: 0.795–1.716; P = 0.428) for AEs, 1.120 (95% CI: 0.644–1.946; P = 0.689) for SAEs, and 1.576 (95% CI: 0.657–3.780; P = 0.308) for infections.

Conclusion

The denosumab biosimilars demonstrated efficacy and safety profiles comparable to the originator in the treatment of postmenopausal osteoporosis.