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Challenges for the Development of Bone-Forming Agents in Europe

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References

  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 8:136

    Google Scholar 

  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 24:23–57

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  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 23:2257–2276

    Article  CAS  PubMed  Google Scholar 

  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 6:59–155

    Article  CAS  PubMed  Google Scholar 

  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 20:177–184

    Article  CAS  PubMed  Google Scholar 

  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. 2

  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 370:412–420

    Article  CAS  PubMed  Google Scholar 

  8. Becker CB (2014) Sclerostin inhibition for osteoporosis—a new approach [comment]. N Engl J Med 370:476–477

    Article  CAS  PubMed  Google Scholar 

  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 19:1395–1408

    Article  CAS  PubMed  Google Scholar 

  10. Kanis JA, McCloskey E, Johansson H, Oden A, Leslie WD (2012) FRAX® with and without BMD. Calcif Tissue Int 90:1–13

    Article  CAS  PubMed  Google Scholar 

  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 23:2239–2256

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  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 301:513–521

    Article  CAS  PubMed  Google Scholar 

  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 13:323–330

    Article  CAS  PubMed  Google Scholar 

  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 14:61–68

    Article  CAS  PubMed  Google Scholar 

  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 18:1254–1260

    Article  PubMed  Google Scholar 

  16. Johnell O, Kanis J, Gullberg G (2001) Mortality, morbidity, and assessment of fracture risk in male osteoporosis. Calcif Tissue Int 69:182–184

    Article  CAS  PubMed  Google Scholar 

  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 12:417–427

    Article  CAS  PubMed  Google Scholar 

  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

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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.

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Authors and Affiliations

  1. Centre for Metabolic Bone Diseases, University of Sheffield Medical School, University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK

    John A. Kanis

  2. Division of Bone Diseases, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland

    Rene Rizzoli

  3. MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK

    Cyrus Cooper

  4. NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, UK

    Cyrus Cooper

  5. Department of Public Health, Epidemiology and Health Economics, University of Liège, Liège, Belgium

    Jean-Yves Reginster

Authors
  1. John A. Kanis
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  2. Rene Rizzoli
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  3. Cyrus Cooper
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  4. Jean-Yves Reginster
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Corresponding author

Correspondence to John A. Kanis.

Additional information

JAK has received consulting fees, advisory board fees, lecture fees, and/or grant support from the majority of companies concerned with skeletal metabolism. C C has received consulting fees and paid advisory boards for Alliance for Better Bone Health, GlaxoSmithKline, Roche, Merck Sharp and Dohme, Lilly, Amgen, Wyeth, Novartis, Servier, and Nycomed. RR: Paid advisory boards and lecture fee for Merck Sharp and Dohme, Eli Lilly, Amgen, Servier, Takeda, and Danone. J-Y R on behalf of the Department of Public Health, Epidemiology and Health Economics of the University of Liège, Liège, Belgium. Consulting fees or paid advisory boards: Servier, Novartis, Negma, Lilly, Wyeth, Amgen, GlaxoSmithKline, Roche, Merckle, Nycomed, NPS, Theramex, UCB. Lecture fees when speaking at the invitation of a commercial sponsor: Merck Sharp and Dohme, Lilly, Rottapharm, IBSA, Genevrier, Novartis, Servier, Roche, GlaxoSmithKline, Teijin, Teva, Ebewee Pharma, Zodiac, Analis, Theramex, Nycomed, Novo-Nordisk.

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Kanis, J.A., Rizzoli, R., Cooper, C. et al. Challenges for the Development of Bone-Forming Agents in Europe. Calcif Tissue Int 94, 469–473 (2014). https://doi.org/10.1007/s00223-014-9844-9

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  • DOI: https://doi.org/10.1007/s00223-014-9844-9

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