Advertisement

Calcified Tissue International

, Volume 94, Issue 5, pp 469–473 | Cite as

Challenges for the Development of Bone-Forming Agents in Europe

  • John A. KanisEmail author
  • Rene Rizzoli
  • Cyrus Cooper
  • Jean-Yves Reginster
Review
In recent years, significant advances have been made in the management of osteoporosis, particularly with respect to the development of pharmacological interventions to reduce fracture risk. Approved pharmacological interventions in Europe include bisphosphonates, strontium ranelate, raloxifene, bazedoxifene, denosumab, and parathyroid hormone peptides [ 1, 2, 3, 4] (Table  1). Treatments are approved for osteoporosis in postmenopausal women, but alendronate, etidronate, risedronate zoledronic acid, and teriparatide are also approved for the prevention and treatment of glucocorticoid-induced osteoporosis in Europe [ 3], and alendronate, risedronate, zoledronic acid, strontium ranelate, and teriparatide are approved for the treatment of osteoporosis in men.
Table 1

Pharmacological interventions used in the EU for the prevention of osteoporotic fractures [4]

Intervention

Year of market approval

Dosing regimen

Route of administration

Alendronate

1995

70 mg once weekly or 5 or 10 mg once daily

Keywords

Bone Mineral Density Zoledronic Acid Teriparatide Denosumab Risedronate 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

The authors consulted Amgen (Andreas Grauer), Asahi Kasei Pharma (Koshi Sakamoto, Yasuo Nakamura, Masaya Etoh), Servier (Florence Petit Dop, Yannis Tsouderos), and UCB (John Caminis) to discuss problems in the development of bone-forming agents. The consultees had no part in the writing of this report.

References

  1. 1.
    Hernlund E, Svedbom A, Ivergård M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jönsson B, Kanis JA (2013) Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos 8:136Google Scholar
  2. 2.
    Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R, Reginster JY, Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO); Committee of Scientific Advisors of the International Osteoporosis Foundation (IOF) (2013) European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int 24:23–57PubMedCentralPubMedCrossRefGoogle Scholar
  3. 3.
    Lekamwasam S, Adachi JD, Agnusdei D, Bilezikian J, Boonen S, Borgström F, Cooper C, Diez Perez A, Eastell R, Hofbauer LC, Kanis JA, Langdahl BL, Lesnyak O, Lorenc R, McCloskey E, Messina OD, Napoli N, Obermayer-Pietsch B, Ralston SH, Sambrook PN, Silverman S, Sosa M, Stepan J, Suppan G, Wahl DA, Compston JE, Joint IOF-ECTS GIO Guidelines Working Group (2012) A framework for the development of guidelines for the management of glucocorticoid-induced osteoporosis. Osteoporos Int 23:2257–2276PubMedCrossRefGoogle Scholar
  4. 4.
    Strom O, Borgstrom F, Kanis JA, Compston J, Cooper C, McCloskey EV, Jonsson B (2011) Osteoporosis: burden, health care provision and opportunities in the EU: a report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos 6:59–155PubMedCrossRefGoogle Scholar
  5. 5.
    Riggs BL, Parfitt AM (2005) Drugs used to treat osteoporosis: the critical need for a uniform nomenclature based on their action on bone remodeling. J Bone Miner Res 20:177–184PubMedCrossRefGoogle Scholar
  6. 6.
    Committee for Medicinal Products for Human Use (CHMP) (2006) Guideline on the evaluation of new medical products in the treatment of primary osteoporosis. European Medicines Agency, London, UK, November 2006. Document CPMP/EWP/552/95, rev. 2Google Scholar
  7. 7.
    McClung MR, Grauer A, Boonen S, Bolognese MA, Brown JP, Diez-Perez A, Langdahl BL, Reginster JY, Zanchetta JR, Wasserman SM, Katz L, Maddox J, Yang YC, Libanati C, Bone HG (2014) Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med 370:412–420PubMedCrossRefGoogle Scholar
  8. 8.
    Becker CB (2014) Sclerostin inhibition for osteoporosis—a new approach [comment]. N Engl J Med 370:476–477PubMedCrossRefGoogle Scholar
  9. 9.
    Kanis JA, McCloskey EV, Johansson H, Strom O, Borgstrom F, Oden A (2008) Case finding for the management of osteoporosis with FRAX—assessment and intervention thresholds for the UK. Osteoporos Int 19:1395–1408PubMedCrossRefGoogle Scholar
  10. 10.
    Kanis JA, McCloskey E, Johansson H, Oden A, Leslie WD (2012) FRAX® with and without BMD. Calcif Tissue Int 90:1–13PubMedCrossRefGoogle Scholar
  11. 11.
    Kanis JA, Odén A, McCloskey EV, Johansson H, Wahl D, Cyrus Cooper C, IOF Working Group on Epidemiology and Quality of Life (2012) A systematic review of hip fracture incidence and probability of fracture worldwide. Osteoporos Int 23:2239–2256PubMedCentralPubMedCrossRefGoogle Scholar
  12. 12.
    Bliuc D, Nguyen ND, Milch VE, Nguyen TV, Eisman JA, Center JR (2009) Mortality risk associated with low-trauma osteoporotic fracture and subsequent fracture in men and women. JAMA 301:513–521PubMedCrossRefGoogle Scholar
  13. 13.
    Gabriel SE, Tosteson AN, Leibson CL, Crowson CS, Pond GR, Hammond CS, Melton LJ 3rd (2002) Direct medical costs attributable to osteoporotic fractures. Osteoporos Int 13:323–330PubMedCrossRefGoogle Scholar
  14. 14.
    Hasserius R, Karlsson MK, Nilsson BE, Redlund-Johnell I, Johnell O (2003) Prevalent vertebral deformities predict increased mortality and increased fracture rate in both men and women: a 10-year population-based study of 598 individuals from the Swedish cohort in the European Vertebral Osteoporosis Study. Osteoporos Int 14:61–68PubMedCrossRefGoogle Scholar
  15. 15.
    Jalava T, Sarna S, Pylkkänen L, Mawer B, Kanis JA, Selby P, Davies M, Adams J, Francis RM, Robinson J, McCloskey E (2003) Association between vertebral fracture and increased mortality in osteoporotic patients. J Bone Miner Res 18:1254–1260PubMedCrossRefGoogle Scholar
  16. 16.
    Johnell O, Kanis J, Gullberg G (2001) Mortality, morbidity, and assessment of fracture risk in male osteoporosis. Calcif Tissue Int 69:182–184PubMedCrossRefGoogle Scholar
  17. 17.
    Kanis JA, Oden A, Johnell O, Jonsson B, de Laet C, Dawson A (2001) The burden of osteoporotic fractures: a method for setting intervention thresholds. Osteoporos Int 12:417–427PubMedCrossRefGoogle Scholar
  18. 18.
    Committee for Medicinal Products for Human Use (CHMP) (2013) Guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus, cutaneous lupus and lupus nephritis. EMA/CHMP/51230/2013, draft 21, February 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500139615.pdf

Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • John A. Kanis
    • 1
    Email author
  • Rene Rizzoli
    • 2
  • Cyrus Cooper
    • 3
    • 4
  • Jean-Yves Reginster
    • 5
  1. 1.Centre for Metabolic Bone Diseases, University of Sheffield Medical SchoolUniversity of SheffieldSheffieldUK
  2. 2.Division of Bone DiseasesGeneva University Hospital and Faculty of MedicineGenevaSwitzerland
  3. 3.MRC Lifecourse Epidemiology UnitUniversity of SouthamptonSouthamptonUK
  4. 4.NIHR Musculoskeletal Biomedical Research UnitUniversity of OxfordOxfordUK
  5. 5.Department of Public Health, Epidemiology and Health EconomicsUniversity of LiègeLiègeBelgium

Personalised recommendations