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Denosumab

Nature Reviews Drug Discovery volume 9, pages 591–592 (2010)Cite this article

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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.

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References

  1. Cummings, S. R. & Melton, L. J. III Epidemiology and outcomes of osteoporotic fractures. Lancet 359, 1761–1767 (2002).

    Article  Google Scholar 

  2. Goltzman, D. Discoveries, drugs and skeletal disorders. Nature Rev. Drug Discov. 1, 784–796 (2002).

    CAS  Article  Google Scholar 

  3. Shahinian, V. B. et al. Risk of fracture after androgen deprivation for prostate cancer. N. Engl. J. Med. 352, 154–164 (2005).

    CAS  Article  Google Scholar 

  4. Boyle, W. J. et al. Osteoclast differentiation and activation. Nature 423, 337–342 (2003).

    CAS  Article  Google Scholar 

  5. Rizzoli, R. et al. Management of osteoporosis in the elderly. Curr. Med. Res. Opin. 25, 2373–2387 (2009).

    CAS  Article  Google Scholar 

  6. Lacey, D. L. et al. Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell 93, 165–176 (1998).

    CAS  Article  Google Scholar 

  7. US Food and Drug Administration. FDA labelling information — Prolia (denosumab). FDA website [online], (2010).

  8. European Medicines Agency (EMA). European Public Assessment Report — Prolia. EMA website [online], (2010).

  9. 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).

    CAS  Article  Google Scholar 

  10. Cummings, S. R. et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N. Engl. J. Med. 361, 756–765 (2009).

    CAS  Article  Google Scholar 

  11. Smith, M. R. et al. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N. Engl. J. Med. 361, 745–755 (2009).

    CAS  Article  Google Scholar 

  12. 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).

    CAS  Article  Google Scholar 

  13. 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).

    CAS  Article  Google Scholar 

  14. Kanis, J. A. et al. European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporosis Int. 19, 399–428 (2008).

    CAS  Article  Google Scholar 

  15. 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).

    CAS  Article  Google Scholar 

  16. 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).

    Article  Google Scholar 

  17. 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).

    CAS  Article  Google Scholar 

  18. IMS MIDAS (IMS Health, 2009).

  19. Schmidt, E. SG Cowen Biotechnology report on Amgen. (SG Cowen, 2 Jun 2010).

    Google Scholar 

  20. Holley, B. et al. Oppenheimer Equity Research Report. (Oppenheimer, 2 Jun 2010).

    Google Scholar 

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Acknowledgements

U.Y. would like to thank D. Hanicq for assistance in data collection.

Author information

Affiliations

  1. René Rizzoli is at the Division of Bone Diseases, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, 24, rue Micheli-du-crest, 1211, Geneva 14, Switzerland. Rene.Rizzoli@unige.ch

    René Rizzoli

  2. Uma Yasothan is at IMS Health, 7 Harewood Avenue, London NW1 6JB, UK. uyasothan@de.imshealth.com

    Uma Yasothan

  3. Peter Kirkpatrick is at Nature Reviews Drug Discovery. p.kirkpatrick@nature.com

    Peter Kirkpatrick

Authors
  1. René Rizzoli
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  2. Uma Yasothan
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  3. Peter Kirkpatrick
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Competing interests

R.R. is an advisory board member for Amgen, Novartis, Roche, Servier, Nycomed, Danone and Merck.

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Rizzoli, R., Yasothan, U. & Kirkpatrick, P. Denosumab. Nat Rev Drug Discov 9, 591–592 (2010). https://doi.org/10.1038/nrd3244

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