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Denosumab: A Review of its Use in Postmenopausal Women with Osteoporosis

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Abstract

Subcutaneous denosumab (Prolia® [USA, Europe]; Pralia® [Japan]) once every 6 months is indicated in several countries for the treatment of postmenopausal women with osteoporosis at increased or high risk for fractures (featured indication). In some countries, it is also indicated for use in postmenopausal women who have failed or are intolerant to other osteoporosis treatments. In several international, phase III trials (≤3 years’ duration) involving more than 12,000 women with postmenopausal osteoporosis or low bone mineral density (BMD), including Asian studies, denosumab was an effective and generally well tolerated treatment. Relative to placebo, denosumab treatment significantly reduced the risk of vertebral, nonvertebral and hip fractures and increased BMD at all skeletal sites evaluated, including the lumbar spine and total hip. Furthermore, the benefits of denosumab treatment were generally evident after the first dose and were maintained during up to 8 years of treatment in an ongoing extension study. The tolerability profile of denosumab during this extension phase was consistent with that observed during the initial 3-year FREEDOM trial. At 12 months, denosumab treatment increased BMD at the total hip, lumbar spine and/or femoral neck and reduced markers of bone turnover to a significantly greater extent than oral bisphosphonates in women who were essentially bisphosphonate-naive and in those who had switched from alendronate to denosumab treatment. Further clinical experience, including an ongoing postmarketing safety study, will more fully define the long-term safety of denosumab. In the meantime, denosumab is an important option for the treatment of women with postmenopausal osteoporosis at increased or high-risk of fractures, including in women at increased risk of fracture who are unable to take other osteoporosis treatments.

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Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit. Lesley Scott is a salaried employee of Adis/Springer.

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    Lesley J. Scott

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The manuscript was reviewed by: J-P. Devogelaer, Universite Catholique de Lovain, Service de Rheumatologie, Cliniques Universitaires Saint-Luc, Brussels, Belgium; M. Kleerekoper, University of Toledo Medical School, Department of Internal Medicine, Endocrinology Division, Ruppert Health Center, Toledo, OH, USA; M. R. McClung, Oregon Osteoporosis Center, Portland, OR, USA; J-Y. Reginster, University of Liège, Department of Public Health Sciences, Bone and Cartilage Metabolism Unit, Liège, Belgium.

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Scott, L.J. Denosumab: A Review of its Use in Postmenopausal Women with Osteoporosis. Drugs Aging 31, 555–576 (2014). https://doi.org/10.1007/s40266-014-0191-3

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