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Denosumab: A Review in Postmenopausal Osteoporosis

  • Adis Drug Evaluation
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An Author Correction to this article was published on 09 March 2018

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Abstract

Denosumab (Prolia®; Pralia®) is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once every 6 months and is approved for various indications, including the treatment of postmenopausal (PM) women with osteoporosis at increased/high risk of fracture or failure/intolerance of other osteoporosis therapies (indications featured in this review). Denosumab showed benefit in several phase 3 or 4 studies in PM women with osteoporosis or low bone mineral density (BMD), including the pivotal 3-year double-blind FREEDOM trial and its 7-year open-label extension. Denosumab reduced the risk of vertebral, nonvertebral and hip fractures and increased BMD across skeletal sites versus placebo in FREEDOM, with these benefits maintained over up to 10 years’ therapy in the extension. The drug was also more effective in improving BMD than bisphosphonates, including in women switched from a bisphosphonate regimen, in 1-year trials; however, whether these differences translate into differences in anti-fracture efficacy is unclear. Denosumab was generally well tolerated over up to 10 years’ treatment, although an increased risk of multiple vertebral fractures was observed after discontinuation of the drug. Thus, denosumab is a key treatment option for PM women with osteoporosis who have an increased/high risk of fracture or failure/intolerance of other osteoporosis therapies, although the potential for multiple vertebral fractures to occur after discontinuation of the drug requires consideration of subsequent management options.

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Change history

  • 09 March 2018

    In the original publication the name of the fourth reviewer was incorrectly published.

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Acknowledgements

During the peer review process, the manufacturer of denosumab was also offered the opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Emma D. Deeks

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Correspondence to Emma D. Deeks.

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The preparation of this review was not supported by any external funding.

Conflict of interest

Emma Deeks is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest. Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/83DCF0601F22BC6B.

Additional information

The manuscript was reviewed by: B. L. Clarke, Division of Endocrinology, Diabetes, Metabolism, Mayo Clinic, Rochester, MN, USA; J.-P. Devogelaer, Service de Rhumatologie, Cliniques Universitaires Saint-Luc, Universite Catholique de Louvain, Brussels, Belgium; D. A. Hanley, Department of Medicine, Division of Endocrinology and Metabolism, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Y.-V. Reginster, Bone and Cartilage Metabolism Unit, Department of Public Health Sciences, University of Liege, Liege, Belgium.

A correction to this article is available online at https://doi.org/10.1007/s40266-018-0535-5.

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Deeks, E.D. Denosumab: A Review in Postmenopausal Osteoporosis. Drugs Aging 35, 163–173 (2018). https://doi.org/10.1007/s40266-018-0525-7

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