Risedronate versus alendronate in older patients with osteoporosis at high risk of fracture: an Italian cost-effectiveness analysis Authors
First Online: 25 July 2013 Received: 04 December 2009 Accepted: 03 February 2010 DOI:
10.1007/BF03324794 Cite this article as: Berto, P., Maggi, S., Noale, M. et al. Aging Clin Exp Res (2010) 22: 179. doi:10.1007/BF03324794 Abstract Background and aims: This evaluation of the cost-effectiveness of risedronate vs generic alendronate is based on effectiveness data from a large real practice study. Applying a published cost-effectiveness model, we found that risedronate is cost-effective vs generic alendronate in an Italian population aged ≥65 years, and becomes dominant, saving costs and avoiding fractures, in patients aged ≥75 years. The aim of this work was to assess the cost-effectiveness and health utility of risedronate vs generic alendronate in clinical practice in Italy, using effectiveness data from the REAL study. Methods: A pre-existing model of osteoporosis was used to predict numbers of fractures, quality-adjusted life-years (QALYs), and costs associated with risedronate or alendronate treatment in post-menopausal (PMO) women aged ≥65 years with a previous vertebral fracture, within the Italian National Health System (NHS). Duration of treatment with risedronate or alendronate was assumed to occur for one year and patients were followed for an additional five years to capture long-term costs and outcomes, with a discount rate of 3% for costs and outcomes. Comprehensive sensitivity analyses were run. Results: The lower fracture rate among risedronate patients with respect to alendronate patients resulted in savings of € 19,083, a reduction of 8.91 hip fractures and an associated benefit of 7.46 QALYs, in an Italian cohort of 1,000 patients. Sensitivity analyses confirmed the robustness of these results. Conclusions: This economic analysis showed that risedronate is a cost-effective treatment in a population of Italian women aged 65 years and older at high risk of PMO-related fractures. Risedronate becomes dominant over generic alendronate in patients of 75 years or older and its cost-effectiveness even appears improved in patients with BMD score <—3 or <—3.5, with/without maternal history of fractures. Risedronate should be considered as a cost-effective option vs generic alendronate, in the Italian NHS’ perspective. Keywords Cost-effectiveness analysis cost/QALY economics generic alendronate osteoporosis risedronate References
WHO. Prevention and management of osteoporosis. 2003. Report No.: Technical Report Series, No 921.
The European House-Ambrosetti. L’osteoporosi in Italia. Dimensione del fenomeno, conseguenze e modalità di gestione del paziente da una somministrazione giornaliera ad una annuale. The European House-Ambrosetti 2008, February 19.
Rossini M, Piscitelli P, Fitto F et al. [Incidence and socioeconomic burden of hip fractures in Italy.]. Reumatismo 2005; 57: 97–102.
Maggi S, Limongi P, Bianchi D et al. Invecchiamento della popolazione e le nuove aree di rischio in sanità. G Gerontol 2006; 54 (Suppl 2): 2–6.
Burge R, Dawson-Hughes B, Solomon DH et al. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005–2025. J Bone Miner Res 2007; 22: 465–75.
International Osteoporosis Foundation. Osteoporosis in the European Community. A call to Action. An audit of policy developments since 1998.
2009 [cited 2009 Apr 20];Available from: URL:
Piscitelli P, Iolascon G, Gimigliano F et al. Incidence and costs of hip fractures compared to acute myocardial infarction in the Italian population: a 4-year survey. Osteoporos Int 2006; 18: 211–9.
Black DM, Cummings SR, Karpf DB et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996; 348: 1535–41.
Black DM, Rosen CJ. Is risedronate or alendronate more effective at preventing nonvertebral fractures in women with osteoporosis? Nat Clin Pract Rheumatol 2007; 3: 378–9.
Chesnut III CH, Skag A, Christiansen C et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in post-menopausal osteoporosis. J Bone Miner Res 2004; 19: 1241–9.
Cummings SR, Black DM, Thompson DE et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA 1998; 280: 2077–82.
Harris ST, Watts NB, Genant HK et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. JAMA 1999; 282: 1344–52.
Reginster J, Minne HW, Sorensen OH et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int 2000; 11: 83–91.
Mellstrom DD, Sorensen OH, Goemaere S et al. Seven years of treatment with risedronate in women with postmenopausal osteoporosis. Calcif Tissue Int 2004; 75: 462–8.
Delmas PD, Vrijens B, Eastell R et al. Effect of monitoring bone turnover markers on persistence with risedronate treatment of postmenopausal osteoporosis. J Clin Endocrinol Metab 2007; 92: 1296–304.
McClung MR, Geusens P, Miller PD et al. Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med 2001; 344: 333–40.
Silverman SL, Watts NB, Delmas PD et al. Effectiveness of bisphosphonates on nonvertebral and hip fractures in the first year of therapy: the risedronate and alendronate (REAL) cohort study. Osteoporos Int 2007; 18: 25–34.
PubMedCentral PubMed CrossRef
Tosteson AN, Jonsson B, Grima DT et al. Challenges for model-based economic evaluations of postmenopausal osteoporosis interventions. Osteoporos Int 2001; 12: 849–57.
Borgstrom F, Zethraeus N. [Economic assessment based on a clinical study of risedronate. Fracture prevention in elderly women with osteoporosis is cost-effective]. Lakartidningen 2003; 100: 36–40.
Brecht JG, Kruse HP, Mohrke W et al. Health-economic comparison of three recommended drugs for the treatment of osteoporosis. Int J Clin Pharmacol Res 2004; 24: 1–10.
Ding H, Koinuma N, Stevenson M et al. The cost-effectiveness of risedronate treatment in Japanese women with osteoporosis. J Bone Miner Metab 2008; 26: 34–41.
Goeree R, Blackhouse G, Adachi J. Cost-effectiveness of alternative treatments for women with osteoporosis in Canada. Curr Med Res Opin 2006; 22: 1425–36.
Grima DT, Papaioannou A, Thompson MF et al. Greater first year effectiveness drives favorable cost-effectiveness of brand risedronate versus generic or brand alendronate: modeled Canadian analysis. Osteoporos Int 2008; 19: 687–97.
Iglesias CP, Torgerson DJ, Bearne A et al. The cost utility of bisphosphonate treatment in established osteoporosis. QJM 2002; 95: 305–11.
Kanis JA, Borgstrom F, Johnell O et al. Cost-effectiveness of risedronate for the treatment of osteoporosis and prevention of fractures in postmenopausal women. Osteoporos Int 2004; 15: 862–71.
Kanis JA, Stevenson M, McCloskey EV et al. Glucocorticoid-induced osteoporosis: a systematic review and cost-utility analysis. Health Technol Assess 2007;11:iii–xi, 1.
AIFA. DETERMINAZIONE 16 luglio 2009 Modifiche, con riferimento alla nota AIFA 79, alla determinazione 22 maggio 2009. Gazzetta Ufficiale della Repubblica Italiana 2009 May 5; 180: 37–43.
ISTAT Istituto Nazionale di Statistica. Tavole di mortalità — Serie storica Anno 2002.
http://demo istat it/unitav/indexhtml?lingua=ita
2009 [cited 2009 Apr 20]
Franzo A, Francescutti C, Simon G. Risk factors correlated with post-operative mortality for hip fracture surgery in the elderly: a population-based approach. Eur J Epidemiol 2005; 20: 985–91.
SER Veneto. Rapporta SISAV Sistema di Indicatori per la Salute dell’Anziano in Veneto.
2007 [cited 2009 Apr 20]
Delmas P, Silverman S, Watts NB et al. Bisphosphonate therapy and hip fractures within the risedronate and alendronate (REAL) cohort study: a comparison to patients with minimal bisphosphonate exposure. J Bone Miner Res 2007; 22 (Suppl 1): S328.
Visentin P, Ciravegna R, Fabris F. Estimating the cost per avoided hip fracture by osteoporosis treatment in Italy. Maturitas 1997; 26: 185–92.
Drummond M, Stoddard G, Torrance G. Methods for the economic evaluation of healthcare programmes. First ed. New York: Oxf. Un. Press; 1987.
Statistics Canada. Life Tables Canada and Provinces. 1990–1992. StatsCan 2007. Catalogue Number 84–537
Tosteson AN, Gabriel SE, Grove MR et al. Impact of hip and vertebral fractures on quality-adjusted life years. Osteoporos Int 2001; 12: 1042–9.
Siegel JE, Torrance GW, Russell LB et al. Guidelines for pharmacoeconomic studies. Recommendations from the panel on cost effectiveness in health and medicine. Panel on cost Effectiveness in Health and Medicine. Pharmacoeconomics 1997; 11: 159–68.
ISTAT Istituto Nazionale di Statistica. Popolazione Residente per età, sesso e stato civile al 1° gennaio 2007.
2009 April 20 [cited 2009 Apr 20]
Maggi S, Noale M, Gonnelli S et al. Quantitative ultrasound calcaneous measurements: normative data for the Italian population. the ESOPO study. J Clin Densitom 2007; 10: 340–6.
Fattore G, AES Gruppo di lavoro. Proposta di linee-guida per la valutazione economica degli interventi sanitari. Documenta per la discussione. Pharmacoeconomics Italian Research Articles 2009; 11: 83–93.
Zethraeus N, Borgstrom F, Jonsson B. Costs and quality of life related to vertebral fractures: preliminary results based on an ongoing Swedish prospective study. Osteoporos Int 2004; 15 (Suppl 1): S1–S145.
Curtis JR, Westfall AO, Cheng H et al. RisedronatE and ALendronate Intervention over Three Years (REALITY): minimal differences in fracture risk reduction. Osteoporos Int 2009; 20: 973–8.
PubMedCentral PubMed CrossRef
Cadarette SM, Katz JN, Brookhart MA et al. Relative effectiveness of osteoporosis drugs for preventing nonvertebral fracture. Ann Intern Med 2008; 148: 637–46.
PubMedCentral PubMed CrossRef
Gruppo Cegedim BCs. Thales Survey October 2006 — data on file Sanofi-Aventis 2009
Zethraeus N, Borgstrom F, Strom O et al. Cost-effectiveness of the treatment and prevention of osteoporosis — a review of the literature and a reference model. Osteoporos Int 2007; 18: 9–23.
Borgstrom F, Johnell O, Kanis JA et al. At what hip fracture risk is it cost-effective to treat? International intervention thresholds for the treatment of osteoporosis. Osteoporos Int 2006; 17: 1459–71.
PubMed CrossRef Copyright information
© Springer Internal Publishing Switzerland 2010