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The Clinical Effectiveness of Denosumab (Prolia®) for the Treatment of Osteoporosis in Postmenopausal Women, Compared to Bisphosphonates, Selective Estrogen Receptor Modulators (SERM), and Placebo: A Systematic Review and Network Meta-Analysis

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Abstract

To assess the effectiveness and safety of denosumab (Prolia®) compared to bisphosphonates (alendronate, ibandronate, risedronate, zoledronate), selective estrogen receptor modulators (SERMs; bazedoxifene, raloxifene) or placebo, for the treatment of osteoporosis in postmenopausal women (PMW). Systematic searches were run in PubMed, Embase & Cochrane Library on 27-April-2022. Randomized controlled trials (RCTs) that included osteoporotic PMW allocated to denosumab, SERMs, bisphosphonates, or placebo were eligible for inclusion. RCTs were appraised using Cochrane Risk of Bias 2.0. Bayesian network and/or pairwise meta-analyses were conducted on predetermined outcomes (i.e. vertebral/nonvertebral fractures, bone mineral density [BMD], mortality, adverse events [AEs], serious AEs (SAEs), withdrawals due to AEs, AEs caused by denosumab discontinuation). A total of 12 RCTs (k = 22 publications; n = 25,879 participants) were included in the analyses. Denosumab, reported a statistically significant increase in lumbar spine (LS) and total hip (TH) BMD, compared to placebo. Similarly, denosumab also resulted in a statistically significant increase in TH BMD compared to the raloxifene and bazedoxifene. However, relative to denosumab, alendronate, ibandronate and risedronate resulted in significant improvements in both femoral neck (FN) and LS BMD. With regards to vertebral fractures and all safety outcomes, there were no statistically significant differences between denosumab and any of the comparator. Relative to placebo, denosumab was associated with significant benefits in both LS and TH BMD. Additionally, denosumab (compared to placebo) was not associated with reductions in vertebral and nonvertebral fractures. Finally, denosumab was not associated with improvement in safety outcomes, compared to placebo. These findings should be interpreted with caution as some analyses suffered from statistical imprecision.

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All data generated or analyzed during this study are included in this published article or in the data repositories listed in the references.

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Acknowledgements

The authors would like to Virginie Gaget for her assistance with collating the background information.

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The research project was funded by the Swiss Federal Office of Public Health (FOPH).

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  1. Research & Evaluation incorporating ASERNIP–S, Royal Australasian College of Surgeons, 24 King William Street, Kent Town, South Australia, 5067, Australia

    Magdalena Ruth Moshi, Konstance Nicolopoulos, Danielle Stringer, Ning Ma & Thomas Vreugdenburg

  2. Health Technology Assessment Section, Health Insurance Benefits Division, Health and Accident Insurance Directorate, Federal Office of Public Health (FOPH), Bern, Switzerland

    Mathias Jenal

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Contributions

MM, KN, MJ, and TV: designed the study. MM and KN: prepared the manuscript. MM, KN, DS, and TV: contributed to the data collection and analysis. MM and NM: were responsible for statistical analysis of the data. All authors revised the paper critically for intellectual content and approved the final version. All authors agree to be accountable for the work and to ensure that any questions relating to the accuracy and integrity of the paper are investigated and properly resolved.

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Correspondence to Magdalena Ruth Moshi.

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Magdalena Moshi, Konstance Nicolopoulos, Danielle Stringer, Mathias Jenal, Ning Ma, Thomas Vreugdenburg has no conflicts to disclose.

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Moshi, M.R., Nicolopoulos, K., Stringer, D. et al. The Clinical Effectiveness of Denosumab (Prolia®) for the Treatment of Osteoporosis in Postmenopausal Women, Compared to Bisphosphonates, Selective Estrogen Receptor Modulators (SERM), and Placebo: A Systematic Review and Network Meta-Analysis. Calcif Tissue Int 112, 631–646 (2023). https://doi.org/10.1007/s00223-023-01078-z

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