Abstract
In May 2010, denosumab (Prolia; Amgen) was granted marketing authorization by the European Commission for the treatment of postmenopausal women with osteoporosis who are at increased risk of fracture, and for the treatment of bone loss associated with hormone ablation therapy in men with prostate cancer at increased risk of fracture. Shortly after, in June 2010, denosumab was approved by the US FDA for the treatment of postmenopausal women with osteoporosis at high risk of fracture.
This is a preview of subscription content, access via your institution
Relevant articles
Open Access articles citing this article.
-
Circular RNA circIKBKB promotes breast cancer bone metastasis through sustaining NF-κB/bone remodeling factors signaling
Molecular Cancer Open Access 29 July 2021
-
Lycorine suppresses RANKL-induced osteoclastogenesis in vitro and prevents ovariectomy-induced osteoporosis and titanium particle-induced osteolysis in vivo
Scientific Reports Open Access 04 August 2015
Access options
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
Cummings, S. R. & Melton, L. J. III Epidemiology and outcomes of osteoporotic fractures. Lancet 359, 1761–1767 (2002).
Goltzman, D. Discoveries, drugs and skeletal disorders. Nature Rev. Drug Discov. 1, 784–796 (2002).
Shahinian, V. B. et al. Risk of fracture after androgen deprivation for prostate cancer. N. Engl. J. Med. 352, 154–164 (2005).
Boyle, W. J. et al. Osteoclast differentiation and activation. Nature 423, 337–342 (2003).
Rizzoli, R. et al. Management of osteoporosis in the elderly. Curr. Med. Res. Opin. 25, 2373–2387 (2009).
Lacey, D. L. et al. Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell 93, 165–176 (1998).
US Food and Drug Administration. FDA labelling information — Prolia (denosumab). FDA website [online], (2010).
European Medicines Agency (EMA). European Public Assessment Report — Prolia. EMA website [online], (2010).
Kostenuik, P. J. et al. Denosumab, a fully human monoclonal antibody to RANKL, inhibits bone resorption and increases BMD in knock-in mice that express chimeric (murine/human) RANKL. J. Bone Miner. Res. 24, 182–195 (2009).
Cummings, S. R. et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N. Engl. J. Med. 361, 756–765 (2009).
Smith, M. R. et al. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N. Engl. J. Med. 361, 745–755 (2009).
Lippuner, K. et al. Remaining lifetime and absolute 10-year probabilities of osteoporotic fracture in Swiss men and women. Osteoporosis Int. 20, 1131–1140 (2009).
Kanis, J. A. et al. FRAX and the assessment of fracture probability in men and women from the UK. Osteoporosis Int. 19, 385–397 (2008).
Kanis, J. A. et al. European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporosis Int. 19, 399–428 (2008).
Rabenda, V. et al. Poor adherence to oral bisphosphonate treatment and its consequences: a review of the evidence. Expert Opin. Pharmacother. 10, 2303–2315 (2009).
Siris, E. S. et al. Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clin. Proc. 81, 1013–1022 (2006).
Kendler, D. L. et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J. Bone Miner. Res. 25, 72–81 (2010).
IMS MIDAS (IMS Health, 2009).
Schmidt, E. SG Cowen Biotechnology report on Amgen. (SG Cowen, 2 Jun 2010).
Holley, B. et al. Oppenheimer Equity Research Report. (Oppenheimer, 2 Jun 2010).
Acknowledgements
U.Y. would like to thank D. Hanicq for assistance in data collection.
Author information
Authors and Affiliations
Ethics declarations
Competing interests
R.R. is an advisory board member for Amgen, Novartis, Roche, Servier, Nycomed, Danone and Merck.
Rights and permissions
About this article
Cite this article
Rizzoli, R., Yasothan, U. & Kirkpatrick, P. Denosumab. Nat Rev Drug Discov 9, 591–592 (2010). https://doi.org/10.1038/nrd3244
Issue Date:
DOI: https://doi.org/10.1038/nrd3244
This article is cited by
-
Circular RNA circIKBKB promotes breast cancer bone metastasis through sustaining NF-κB/bone remodeling factors signaling
Molecular Cancer (2021)
-
Hypocalcemia and bone mineral density changes following denosumab treatment in end-stage renal disease patients: a meta-analysis of observational studies
Osteoporosis International (2018)
-
Bone-seeking agents for the treatment of bone disorders
Drug Delivery and Translational Research (2017)
-
Lycorine suppresses RANKL-induced osteoclastogenesis in vitro and prevents ovariectomy-induced osteoporosis and titanium particle-induced osteolysis in vivo
Scientific Reports (2015)
-
Treatment of post-menopausal osteoporosis: beyond bisphosphonates
Journal of Endocrinological Investigation (2015)