A FRAX® model for the assessment of fracture probability in Belgium

Background: Denosumab has recently been shown to be well tolerated, to increase bone mineral density (BMD) and to significantly reduce the risk of hip, vertebral and non-vertebral fractures in the FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months) trial. It is becoming increasingly important to evaluate not only the therapeutic value of a new drug but also the cost effectiveness compared with the most relevant treatment alternatives. Objective: The objective of this study was to estimate the cost effectiveness of denosumab compared with oral bisphosphonates (branded and generic drugs) in the treatment of post-menopausal osteoporotic women in Belgium. Methods: Cost effectiveness of 3 years of treatment with denosumab was compared with branded risedronate and branded and generic alendronate using an updated version of a previously validated Markov microsimulation model. The model was populated with relevant cost, adherence and epidemiological data for Belgium from a payer perspective and the results were presented as costs per QALY gained (h, year 2009 values). Analyses were performed in populations (aged ‡60 years) in which osteoporosis medications are currently reimbursed in many European countries, i.e. those with BMD T-score of -2.5 or less or prevalent vertebral fracture. Patients receiving denosumab were assumed to have a 46% lower risk of discontinuation than those receiving oral bisphosphonates, and the effect of denosumab after treatment cessation was assumed to decline linearly to zero over a maximum of 1 year. Results: Denosumab was cost effective compared with all other therapies, assuming a willingness to pay of h40 000 per QALY gained. In particular, denosumab was found to be cost effective compared with branded alendronate and risedronate at a threshold value of h30 000 per QALY and denosumab was dominant (i.e. lower cost and greater effectiveness) compared with risedronate from the age of 70 years in women with a T-score of -2.5 or less and no prior fractures. The cost effectiveness of denosumab compared

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“…[78,79] FRAX Ò has recently become available in Belgium. [80] Our simulation model is currently not able to estimate intervention thresholds.…”

Section: Discussionmentioning

confidence: 99%

Cost Effectiveness of Denosumab Compared with Oral Bisphosphonates in the Treatment of Post-Menopausal Osteoporotic Women in Belgium

Hiligsmann

Reginster

2011

PharmacoEconomics

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“…Although low BMD is a major risk factor for fractures (24), most fractures occur in patients with a BMD T score above the operational threshold for osteoporosis (25,26). Recent developments in fracture risk assessment, including the FRAX tool, which estimates the 10-year probability of fracture (27,28), may certainly improve identification of patients at an increased risk of fractures and therefore further decrease the ageadjusted incidence. In addition, numerous studies have shown that a prior fracture greatly increases the risk for future fractures (29 -31), whereas a male patient post-hip fracture has a 60% risk of future fracture within the next 4 years (32,33).…”

Section: Discussionmentioning

confidence: 99%

Trends in hip fracture incidence and in the prescription of antiosteoporosis medications during the same time period in Belgium (2000–2007)

Hiligsmann¹,

Bruyère²,

Roberfroid³

et al. 2012

Arthritis Care & Research

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“…Using FRAX scoring, 10-year fracture risk can be automatically calculated. Ten-year fracture risk possibility increases as risk factors increase (11).…”

Section: Fracture Risk Assessment Toolmentioning

confidence: 99%

Assessment of 10-Year Major Osteoporotic and Femur Fracture Risk of Postmenopausal Women Using FRAX®

Demir¹,

Kutlu²,

Çivi³

2014

Turk J Phys Med Rehab

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ÖzetAmaç: Bu çalışmanın amacı, postmenopozal kadınlarda osteoporoz (OP) risk faktörlerini ve Dünya Sağlık Örgütü (DSÖ) kırık risk değerlendirme skalası (FRAX) kullanılarak 10 yıllık majör OP ile kalça kırığı riskini değer-lendirmektir. Gereç ve Yöntemler: Kesitsel tipteki bu analitik araştırma 340 postmenopozal kadında yapıldı. Katılımcıların risk faktörleri ile kemik mineral yoğunluklarını (KMY) göz önünde bulundurarak ve FRAX risk değerlen-dirme skalası kullanılarak 10 yıllık majör osteoporotik ve kalça kırığı riskleri hesaplandı. Bulgular: Çalışmamızda kadınların yaş ortalamaları 57,5±7,8 idi. 8) osteoporotik, 177'si (%52,1) osteopenik, 116'sı (%34,1) normal olarak bulundu. Yaş arttıkça OP sıklığı artarken (p<0,001), beden kitle indeksi (BKİ) arttıkça OP sıklığı azalıyordu (p<0,001). Osteoporoz varlığı göz önüne alındığında, KMY kullanılarak veya kullanılmadan hesaplanan majör osteoporotik ve kalça kırığı riskleri arasında istatistiksel olarak anlamlı derecede önemli bir ilişki vardı (p<0,001). Kemik mineral yoğunlukları kullanılarak hesaplanan majör osteoporotik kırık riski katı-lanların %94,7'sinde düşük, %5'inde orta ve %0,3'ünde yüksek idi. Osteoporoz risk faktörleri incelendiğinde; 2 ve daha az klinik risk faktörü olanlarda OP sıklığı %12,8 iken, 3 veya 4 risk faktörü olanlarda bu sıklık %28,0 idi. Sonuç: Bu çalışmada, 10 yıllık osteoporotik kırık riskini değerlendirmede KMY kullanılsın ya da kullanılmasın FRAX risk değerlendirme skalasının önemli, maliyet etkin ve kullanması kolay bir değerlendirme kriteri olduğu sonucuna varılmıştır. Anahtar Kelimeler: Osteoporoz, postmenopozal kadın, klinik risk faktörleri, FRAX ® Abstract Objective: The aim of this study is to assess osteoporosis (OP) risk factors in postmenopausal women and 10-year major osteoporosis and femur facture risks using the World Health Organization's fracture risk assessment scale (FRAX ® ). Material and Methods:This cross-sectional analytic study was carried out on 340 postmenopausal women. Considering participant risk factors and bone mineral densities and using the FRAX ® risk assessment scale, their 10-year major osteoporotic and femur fracture was assessed. Results: The mean age of the women in our study was 57.5±7.8. Of the participants, 47 (13.8%) were osteoporotic, 177 (52.1%) were osteopenic, and 116 (34.1%) were normal. As age increased, OP frequency increased (p<0.001), and as body mass index (BMI) increased, OP frequency decreased (p<0.001). Considering OP existence, there was a statistically significant relation between major OP risk and femur fracture risk, calculated using BMD and without using BMD (p<0.001). Major OP fracture risk, calculated using BMD, was low in 94.7% of the subjects, mild in 5.0%, and high in 0.3%. When osteoporosis risk factors were assessed, while OP frequency in those with 2 or fewer clinical risk factors (CRFs) was 12.8%, OP frequency was 28.0% in those with 3 or 4 risk factors. Conclusion: In this study, it was determined that the FRAX ® risk assessment scale, which is used to assess 10-year OP fra...

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A FRAX® model for the assessment of fracture probability in Belgium

Cited by 56 publications

References 52 publications

Cost Effectiveness of Denosumab Compared with Oral Bisphosphonates in the Treatment of Post-Menopausal Osteoporotic Women in Belgium

Cost Effectiveness of Denosumab Compared with Oral Bisphosphonates in the Treatment of Post-Menopausal Osteoporotic Women in Belgium

Trends in hip fracture incidence and in the prescription of antiosteoporosis medications during the same time period in Belgium (2000–2007)

Assessment of 10-Year Major Osteoporotic and Femur Fracture Risk of Postmenopausal Women Using FRAX®

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