Treatment thresholds for osteoporosis and reimbursability criteria: Perspectives associated with fracture risk-assessment tools

Calcified Tissue International

Volumn 93, Issue 3, 2013, Pages 195-200

  Adami, Silvano ^a   Bertoldo, Francesco ^a   Gatti, Davide ^a   Minisola, Giovanni ^c   Rossini, Maurizio ^a   Sinigaglia, Luigi ^b   Varenna, Massimo ^b  

^a UNIVERSITY OF VERONA   (Italy)

^b ISTITUTO ORTOPEDICO GAETANO PINI   (Italy)

^c SAN CAMILLO FORLANINI HOSPITAL   (Italy)

Author keywords

FRAX; Osteoporosis treatment; Pharmacoeconomics; Treatment threshold

Indexed keywords

ALENDRONIC ACID; DENOSUMAB; PARATHYROID HORMONE[1-34]; PLACEBO; RISEDRONIC ACID; STRONTIUM RANELATE; ZOLEDRONIC ACID;

ARTICLE; BONE DENSITY; CALCIUM INTAKE; CLINICAL ASSESSMENT TOOL; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; DISEASE SEVERITY; DRUG COST; DRUG EFFICACY; DUAL ENERGY X RAY ABSORPTIOMETRY; FRAGILITY FRACTURE; HUMAN; OSTEOPOROSIS; PRACTICE GUIDELINE; PRIORITY JOURNAL; REIMBURSEMENT; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK FACTOR; SMOKING CESSATION; SPINE FRACTURE; VITAMIN SUPPLEMENTATION;

ALGORITHMS; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; COST-BENEFIT ANALYSIS; DRUG COSTS; FRACTURE HEALING; FRACTURES, BONE; HUMANS; INCIDENCE; OSTEOPOROSIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RHEUMATOLOGY; RISK; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX;

EID: 84882451189     PISSN: 0171967X     EISSN: 14320827     Source Type: Journal    
DOI: 10.1007/s00223-013-9748-0     Document Type: Article

References (35)

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
3. World Health Organization (2007) Assessment of osteoporosis at the primary health care level. Summary Report of a WHO Scientific Group, WHO, Geneva, Switzerland
4. Consensus Development Conference (1993) Diagnosis, prophylaxis and treatment of osteoporosis. Am J Med 94:646-650
5. NIH Consensus Development Panel (2001) Osteoporosis prevention, diagnosis, and therapy. JAMA 285:785-795
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
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
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
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
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
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
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
16. Adami S, Isaia G, Luisetto G et al (2008) Osteoporosis treatment and fracture incidence: the ICARO longitudinal study. Osteoporos Int 19:1219-1223
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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