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Treatment Thresholds for Osteoporosis and Reimbursability Criteria: Perspectives Associated with Fracture Risk-Assessment Tools

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Abstract

The definition of osteoporosis was based for several years on bone mineral density values, which were used by most guidelines for defining treatment thresholds. The availability of tools for the estimation of fracture risk, such as FRAX™ or its adapted Italian version, DeFRA, is providing a way to grade osteoporosis severity. By applying these new tools, the criteria identified in Italy for treatment reimbursability (e.g., “Nota 79”) are confirmed as extremely conservative. The new fracture risk-assessment tools provide continuous risk values that can be used by health authorities (or “payers”) for identifying treatment thresholds. FRAX estimates the risk for “major osteoporotic fractures,” which are not counted in registered fracture trials. Here, we elaborate an algorithm to convert vertebral and nonvertebral fractures to the “major fractures” of FRAX, and this allows a cost-effectiveness assessment for each drug.

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References

  1. World Health Organization (1994) Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. Technical Report Series 843. WHO, Geneva

  2. Marshall D, Johnell O, Wedel H (1996) Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures. BMJ 312:1254–1259

    Article  CAS  PubMed  Google Scholar 

  3. World Health Organization (2007) Assessment of osteoporosis at the primary health care level. Summary Report of a WHO Scientific Group, WHO, Geneva, Switzerland

    Google Scholar 

  4. Consensus Development Conference (1993) Diagnosis, prophylaxis and treatment of osteoporosis. Am J Med 94:646–650

    Article  Google Scholar 

  5. NIH Consensus Development Panel (2001) Osteoporosis prevention, diagnosis, and therapy. JAMA 285:785–795

    Article  Google Scholar 

  6. Agenzia Italiana del Farmaco. Nota 79. http://www.agenziafarmaco.gov.it/it/content/nota-79. Cited 23 Feb 2013

  7. Kanis JA; on behalf of the WHO Scientific Group (2008) Assessment of osteoporosis at the primary health-care level. Technical Report. WHO Collaborating Centre, University of Sheffield, Sheffield

  8. Kanis JA, Johnell O, Oden A, Johansson H, McCloskey E (2008) FRAX™ and the assessment of fracture probability in men and women from the UK. Osteoporos Int 19:385–397

    Article  CAS  PubMed  Google Scholar 

  9. Dyslipidaemia Advisory Group on behalf of the Scientific Committee of the National Heart Foundation of New Zealand (1996) National Heart Foundation clinical guidelines for the assessment and management of dyslipidaemia. N Z Med J 109:224–232

    Google Scholar 

  10. 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 

  11. Kanis JA, Black D, Cooper C, Dargent P, Dawson-Hughes B, De Laet C (2002) A new approach to the development of assessment guidelines for osteoporosis. Osteoporos Int 13:527–536

    Article  CAS  PubMed  Google Scholar 

  12. Adami S, Bianchi G, Brandi ML, Di Munno O, Frediani B, Gatti D, Giannini S, Girasole G, Minisola G, Minisola S, Nuti R, Pedrazzoni M, Rossini M, Varenna M (2010) Validation and further development of the WHO 10-year fracture risk assessment tool in Italian postmenopausal women: project rationale and description. Clin Exp Rheumatol 28:561–570

    CAS  PubMed  Google Scholar 

  13. National Institute for Health and Clinical Excellence (2011) NICE technology appraisal guidance 161 (amended). Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women (amended). NICE, London

  14. Rossini M, Di Munno O, Gatti D, Giannini S, Minisola S, Varenna M, Adami S (2011) Optimising bisphosphonate treatment outcomes in postmenopausal osteoporosis: review and Italian experience. Clin Exp Rheumatol 29:728–735

    CAS  PubMed  Google Scholar 

  15. Adami S, Isaia G, Luisetto G et al (2006) Fracture incidence and characterization in patients on osteoporosis treatment: the ICARO study. J Bone Miner Res 21:1565–1570

    Article  CAS  PubMed  Google Scholar 

  16. Adami S, Isaia G, Luisetto G et al (2008) Osteoporosis treatment and fracture incidence: the ICARO longitudinal study. Osteoporos Int 19:1219–1223

    Article  CAS  PubMed  Google Scholar 

  17. Adami S, Giannini S, Bianchi G, Sinigaglia L, Di Munno O, Fiore E, Minisola S, Rossini M (2009) Vitamin D status and response to treatment in post-menopausal osteoporosis. Osteoporos Int 20:239–244

    Article  CAS  PubMed  Google Scholar 

  18. Adami S, Maugeri D, Toscano V et al (2011) Baseline characteristic of the population enrolled in the Italian Observational Study on Severe Osteoporosis. Clin Exp Rheumatol 29:477–484

    CAS  PubMed  Google Scholar 

  19. Nuti R, Brandi ML, Isaia G et al (2009) New perspective on the definition and management of severe osteoporosis: the patient with two or more fragility fractures. J Endocrinol Invest 32:783–788

    CAS  PubMed  Google Scholar 

  20. Black DM, Cummings SR, Karpf DB et al (1996) Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 348:1535–1541

    Article  CAS  PubMed  Google Scholar 

  21. Cummings SR, Black DM, Thompson DE et al (1998) Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA 280:2077–2082

    Article  CAS  PubMed  Google Scholar 

  22. Reginster JY, Seeman E, De Vernejoul MC et al (2005) Strontium ranelate reduces the risk of nonvertebral fractures in postmenopausal women with osteoporosis: treatment of Peripheral Osteoporosis (TROPOS) study. J Clin Endocrinol Metab 90:2816–2822

    Article  CAS  PubMed  Google Scholar 

  23. Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA et al (2007) Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 356:1809–1822

    Article  CAS  PubMed  Google Scholar 

  24. McClung MR, Geusens P, Miller PD, Zippel H, Bensen WG, Roux C, Adami S, Fogelman I, Diamond T, Eastell R, Meunier PJ, Reginster JY; Hip Intervention Program Study Group (2001) Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 344:333–340

    Article  Google Scholar 

  25. Cochrane reviews for osteoporosis. http://onlinelibrary.wiley.com/cochranelibrary/search. Cited 24 Feb 2013

  26. Cummings SR, San Martin J, McClung MR (2009) Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 361:756–765

    Article  CAS  PubMed  Google Scholar 

  27. Neer RM, Arnaud CD, Zanchetta JR et al (2001) Effect of parathyroid hormone (1–34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 344:1434–1441

    Article  CAS  PubMed  Google Scholar 

  28. 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) and the 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  Google Scholar 

  29. Lindsay R, Scheele WH, Neer R, Pohl G, Adami S, Mautalen C, Reginster JY, Stepan JJ, Myers SL, Mitlak BH (2004) Sustained vertebral fracture risk reduction after withdrawal of teriparatide in postmenopausal women with osteoporosis. Arch Intern Med 164:2024–2030

    Article  PubMed  Google Scholar 

  30. Black DM, Schwartz AV, Ensrud KE et al FLEX Research Group (2006) Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-Term Extension (FLEX): a randomized trial. JAMA 296:2927–2938

    Article  Google Scholar 

  31. Black DM, Reid IR, Boonen S, Bucci-Rechtweg C et al (2012) The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res 27:243–254

    Article  CAS  PubMed  Google Scholar 

  32. Eastell R, Hannon RA, Wenderoth D, Rodriguez-Moreno J, Sawicki A (2011) Effect of stopping risedronate after long-term treatment on bone turnover. J Clin Endocrinol Metab 96:3367–3373

    Article  CAS  PubMed  Google Scholar 

  33. Ravn P, Christensen JO, Baumann M, Clemmesen B (1998) Changes in biochemical markers and bone mass after withdrawal of ibandronate treatment: prediction of bone mass changes during treatment. Bone 22:559–564

    Article  CAS  PubMed  Google Scholar 

  34. Bone HG, Bolognese MA, Yuen CK et al (2011) Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab 96:972–980

    Article  CAS  PubMed  Google Scholar 

  35. Blake GM, Lewiecki EM, Kendler DL, Fogelman I (2007) A review of strontium ranelate and its effect on DXA scans. J Clin Densitom 10:113–119

    Article  PubMed  Google Scholar 

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Correspondence to Silvano Adami.

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This study was conducted on behalf of the Italian Societies for Osteoporosis (SIOMMMS) and Rheumatology (SIR).

The authors have stated that they have no conflict of interest.

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Adami, S., Bertoldo, F., Gatti, D. et al. Treatment Thresholds for Osteoporosis and Reimbursability Criteria: Perspectives Associated with Fracture Risk-Assessment Tools. Calcif Tissue Int 93, 195–200 (2013). https://doi.org/10.1007/s00223-013-9748-0

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  • DOI: https://doi.org/10.1007/s00223-013-9748-0

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