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Spotlight on Denosumab in Postmenopausal Osteoporosis

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Abstract

Denosumab (Prolia®) is a human recombinant monoclonal antibody that is approved for the treatment of postmenopausal osteoporosis in women at high or increased risk of fracture in the US, the EU, and several other countries. Denosumab has a novel mechanism of action; it binds to receptor activator of nuclear factor κB ligand and inhibits bone resorption by inhibiting osteoclast formation, function, and survival.

In postmenopausal women with osteoporosis, denosumab reduced the risk of vertebral, nonvertebral, and hip fractures compared with placebo over 3 years in the large, phase III FREEDOM study. In postmenopausal women with low bone mineral density (BMD) or osteoporosis, treatment with denosumab increased BMD and decreased markers of bone turnover more than alendronate in those who were essentially treatment-naive in the 1-year DECIDE study and also in the 1-year STAND study, in which women were switched from alendronate to denosumab or continued alendronate treatment. Denosumab was generally well tolerated in clinical trials, although long-term effects of very low bone turnover remain to be established.

Denosumab is administered once every 6 months via subcutaneous injection, which may be a preferred method of administration and may improve adherence to treatment compared with other osteoporosis treatments. Denosumab is a valuable new option for the treatment of postmenopausal osteoporosis in women at increased or high risk of fractures, and may be useful as a first-line treatment in women at increased risk of fractures who are unable to take other osteoporosis treatments.

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Acknowledgments and Disclosures

The full text article[17] from which this spotlight was derived was reviewed by: J.-P. Devogelaer, Service de Rhumatologie, Université Catholique de Louvain, Brussels, Belgium; D.A. Hanley, Departments of Medicine, Community Health Sciences, and Oncology Division of Endocrinology and Metabolism, University of Calgary Faculty of Medicine, Calgary, Alberta, Canada; D.L. Kendler, Prohealth Clinical Research, University of British Columbia, Vancouver, British Columbia, Canada; M. Kleerekoper, Department of Internal Medicine, St Joseph Mercy Hospital, Ann Arbor, Michigan, USA; J.-Y. Reginster, Department of Public Health Sciences, University of Liege, Liege, Belgium.

The manufacturer of the agent under review was offered an opportunity to comment on the original article during the peer review process. Changes based on any comments received were made on the basis of scientific and editorial merit. The preparation of the original article and this spotlight was not supported by any external funding.

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  1. Adis, a Wolters Kluwer Business, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand

    Marit D. Moen & Susan J. Keam

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  1. Marit D. Moen
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  2. Susan J. Keam
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Correspondence to Marit D. Moen.

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Adapted and reproduced from Drugs & Aging 2011; 28 (1): 63–82

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Moen, M.D., Keam, S.J. Spotlight on Denosumab in Postmenopausal Osteoporosis. BioDrugs 25, 261–264 (2011). https://doi.org/10.2165/11207100-000000000-00000

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