Cost-effectiveness of strontium ranelate in the treatment of male osteoporosis.

UNLABELLED: The results of this study suggest that, under the assumption of same relative risk reduction of fractures in men as for women, strontium ranelate could be considered a cost-effective strategy compared with no treatment for the treatment of osteoporotic men from a Belgian healthcare payer perspective. INTRODUCTION: This study was conducted to estimate the cost-effectiveness of strontium ranelate in the treatment of osteoporotic men. METHODS: A previously validated Markov microsimulation model was adapted to estimate the cost (2,010) per quality-adjusted life-year (QALY) gained of strontium ranelate compared with no treatment. Similar efficacy data on lumbar spine and femoral neck bone mineral density (BMD) between men with osteoporosis at high risk of fracture (MALEO Trial) and postmenopausal osteoporotic women (pivotal SOTI, TROPOS trials) supports the assumption, in the base-case analysis, of the same relative risk reduction of fractures in men as for women. Analyses were conducted, from a Belgian healthcare payer perspective, in the population from the MALEO Trial who is a men population with a mean age of 73 years, and BMD T-score ≤-2.5 or prevalent vertebral fracture (PVF). RESULTS: In the MALEO population, strontium ranelate compared with no treatment was estimated at 49,798 and 25,584 per QALY gained using efficacy data from the intent-to-treat analysis and the per-protocol analysis including only adherent patients, respectively. In men with a BMD T-score ≤-2.5 or with PVF, the cost per QALY gained of strontium ranelate fall below thresholds of 45,000 and 25,000 per QALY gained based on efficacy data from the entire population of the clinical trial and from the per-protocol analyses, respectively. CONCLUSIONS: The results of this study suggest that, under the assumption of same relative risk reduction of fractures in men as for women, strontium ranelate could be considered cost-effective compared with no treatment for male osteoporosis.

Validation of OSIRIS, a prescreening tool for the identification of women with an increased risk of osteoporosis.

According to the recent recommendations of the European Community and the World Health Organization, identification of risk factors for fracture or low bone mineral density (BMD) should help health professionals to make a better use of bone densitometry. This includes helping patients to modify their behaviour and act on modifiable risk factors (correction of low calcium intake and vitamin D deficiencies, etc.) and also to provide evidence-based guidance for starting a treatment when necessary. In this context, we previously developed a clinical scoring index, OSIRIS (OSteoporosis Index of RISk), for classifying women into three categories of risk of osteoporosis. In order to evaluate the discriminatory performance of OSIRIS, we performed the present prospective study in a sample of 889 postmenopausal women from France. The osteoporosis risk depends on the OSIRIS category. Thus, 62% of women in the 'high-risk' category (OSIRIS < or = -3) were osteoporotic, compared to 34% of women in the 'intermediate-risk' category (OSIRIS ranged between -3 and +1) and only 16.8% of women in the 'low-risk' category (score OSIRIS > 1). These results might contribute to the development of more efficient screening strategies for osteoporosis. The patients in the low-risk category do not require immediate BMD testing; women with 'intermediate risk' have to be carefully followed by their doctor with BMD testing decided on a case-by-case basis; for those within the high-risk category, treatment may be initiated immediately and BMD testing performed either to assess the efficacy of the treatment or to increase the long-term compliance of the patient. In conclusion, for clinical practice, a user-friendly tool has been developed. This tool, called OSIRIS, as far as a simple rule allows, identifies the level of osteoporosis risk in women.

Validation and comparative evaluation of the osteoporosis self-assessment tool (OST) in a Caucasian population from Belgium.

BACKGROUND: Risk indices have been developed to identify women at risk of low bone mineral density (BMD) who should undergo BMD testing. AIM: To compare the performance of four risk indices in White ambulatory women in Belgium. DESIGN: Epidemiological cross-sectional study. METHODS: Records were analysed for 4035 postmenopausal White women without Paget's disease or advanced osteoarthritis, seen at an out-patient osteoporosis centre between January 1996 and September 1999. Osteoporosis risk index scores were compared to bone density T-scores. The ability of each risk index to identify women with low BMD (T-score < -2.0) or osteoporosis (T < -2.5) was evaluated. RESULTS: Using an Osteoporosis Self-Assessment Tool (OST) score <2 to recommend DXA referral, sensitivity ranged from 85% at the lumbar spine to 97% at the total hip to detect BMD T-scores of

Interest of a prescreening questionnaire to reduce the cost of bone densitometry.

Bone mineral density (BMD) measurement is widely recognized as the best single tool to identify patients with a high lifetime risk of developing an osteoporosis-related fracture. However, the cost/benefit value of screening the whole population has been repeatedly challenged and demonstrated to be rather poor. In many countries, BMD scan is not or no longer reimbursed because of lack of validated criteria to identify patients who should benefit from this procedure. Based on the proposals of a nationwide expert panel, a simple questionnaire identifying historical, clinical and behavioral risk factors for osteoporosis was developed. The aim of this study was to assess the diagnostic accuracy of the proposed criteria; to determine the extent to which this questionnaire could be useful for optimizing the use of densitometry tests; and, more specifically, to estimate the diagnostic costs per osteoporotic or osteopenic patient detected. For this purpose, we applied the questionnaire to 3998 consecutive individuals at least 20 years old, of both genders, either consulting spontaneously or referred for a BMD measurement to an outpatient osteoporosis center. BMD was measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine and at the hip (both total hip and femoral neck). Diagnostic accuracies were evaluated through measures of sensitivity, specificity, and positive and negative predictive values. After determining a benchmark value for age, different strategies were compared in order to identify the most cost-effective one in terms of cost per patient detected. According to the WHO operational definition of osteoporosis (T-score <-2.5), 31% of the subjects were classified as osteoporotic at one or more of the measured sites. If only patients with at least one of the proposed risk factors had been referred for scans, 33.3% of the BMD measurements would have been avoided. Among those, less than 5% were missclassified as they did have osteoporosis at the total hip and up to 23% at one or more of the considered sites. On the other hand, of the subjects who would be recommended for a densitometry test, only a small fraction were identified correctly (the positive predictive values varied from 11.3% at the total hip to 34.8% at any site). In this first setting, the suggested criteria seem useful chiefly for excluding subjects who do not need a DXA scan rather than selecting osteoporotic patients. When applied only to patients aged 61 years or more, the positive predictive values rose to 15.1% (total hip) and 42.9% (any site), whereas the corresponding negative predictive values were set at 93% and 68.6%. In comparison, with a mass screening scenario the estimated diagnostic costs (costs associated with the DXA procedure) per osteoporotic patient detected at any of the considered sites would be reduced by more than 9% (59.4 instead of 65.3 Euros) if the suggested indications are taken into account for prescreening patients. And when the questionnaire is applied only to women over the age of 60 years these costs would be further reduced to 50.6 Euros, representing a 23% decrease. Then, a prescreening strategy based on these indications concomitantly with an age-selective criterion could represent a promising way toward a more rational use of BMD measurement.

Evaluation of the simple calculated osteoporosis risk estimation (SCORE) in a sample of white women from Belgium.

Identifying patients at risk of developing an osteoporosis-related fracture will continue to be a challenge. The "gold standard" for osteoporosis diagnosis is bone densitometry. However, economic issues or availability of the technology may prevent its use under a mass screening scenario. A risk assessment instrument, the "simple calculated osteoporosis risk estimation" (SCORE), has been reported to appropriately identify women likely to have low (t score < or = -2 SD) bone mineral density (BMD) and who should be referred for bone densitometry. The aim of our study is to evaluate the discriminatory performance of SCORE in a random sample of postmenopausal white women from Belgium. For this purpose, we gathered medical data on 4035 consecutive patients aged > or = 45 years, either consulting spontaneously or referred for a BMD measurement to an outpatient osteoporosis center located at the University of Liège, Belgium. BMD measurements, using dual-energy X-ray absorptiometry (DXA) technology, were taken at the hip (total and neck) and lumbar spine (L2-4). At the recommended cutoff point of 6, SCORE had a sensitivity of 91.5% to detect low BMD at any of the measured sites, a specificity of 26.5%, a positive predictive value of 52.8%, and a negative predictive value of 77.7%. According to SCORE, 18% of the patients would not be recommended for densitometry. Among these, 10.9% were misclassified as they had osteoporosis (t score < or = -2.5 SD) at one or more of the sites investigated. The negative predictive errors of SCORE, when failing to detect osteoporosis, were only 1% for the total hip, 3.2% for the femoral neck, and 8.8% for the lumbar spine. We conclude that, notwithstanding the high values of sensitivity, SCORE specificity is too low to be useful as a diagnostic tool for screening patients at high risk to later develop osteoporosis. Nevertheless, from a resource allocation perspective, this instrument can be used with relative confidence to exclude patients who do not need a BMD measurement, and would therefore provide an opportunity to realize substantial cost savings in comparison to a mass screening strategy.

On conducting burden-of-osteoporosis studies: a review of the core concepts and practical issues. A study carried out under the auspices of a WHO Collaborating Center.

Osteoporosis is a problem that is relevant to public health from the clinical, economic and social viewpoints. Except in a handful of industrialized countries, there is a considerable void in our knowledge of the magnitude of the problem. By exploring both the epidemiological and the economic impact of osteoporosis and the fractures associated with it in a particular country, studies of the 'burden of illness' (BOI) can fill that void. BOI analysis raises many questions at both the conceptual and the practical level. The purpose of this paper is to review the methodology underlying analyses of this type, to discuss its limitations and to provide a general format to improve their implementation in the field of osteoporosis. Investigators involved in BOI analysis should be very clear and explicit regarding the methods they adopt, so that studies in different countries can be interpreted and compared appropriately by interested parties.

Direct costs of hip fractures in patients over 60 years of age in Belgium.

OBJECTIVE: Osteoporosis-related costs are now considered a major burden for health authorities in most developed countries. An accurate and exhaustive evaluation of these costs would be a major contribution to health economic studies evaluating the efficiency of screening and prevention strategies. Osteoporosis is the most frequent underlying cause of femoral neck fractures in the elderly; these fractures weigh heavily on healthcare budgets. However, in Belgium, very few data on the financial burden of hip fractures are available and no updated estimates have been made. The goal of this paper is to estimate the direct medical expenditures associated with hip fractures in Belgium in 1996. DESIGN AND SETTING: This 1-year population-based cross-sectional study is conducted from the social security perspective. The target population in this study are men and women aged 60 years and over. PATIENTS AND PARTICIPANTS: We selected patients who had been hospitalised for a hip fracture during the year 1996 who were also affiliated with a registered social security organisation (covering 25% of the Belgian population). The sample constituted 2374 patients. INTERVENTIONS: For each of these patients, we collected an exhaustive and detailed list of healthcare resource use as well as nursing home admissions following the hip fracture event. Cost items investigated in the analysis were inpatient hospital costs and outpatient costs. Mean annual costs per case recorded in the sample were then extrapolated to the whole country on the basis of an exhaustive list of diagnoses having lead to all countrywide hospitalisations (1,700,000 hospital stays/year). MAIN OUTCOME MEASURES AND RESULTS: The mean hospital inpatient costs for hip fracture were evaluated at 332,148 Belgian francs (BeF) [$US8977] per case and BeF4,367,746,200 ($US118,047,194) for the whole country (10 million inhabitants). Patients with a hip fracture experienced an annual BeF27,825 ($US752) extra outpatient cost during the year following this fracture event, after correcting for costs related to additional comorbidity already present before the hip fracture. Finally, after a proximal femoral neck fracture, the rate of nursing home admission was higher, both for men and women at any age compared with age- and gender-matched population. CONCLUSIONS: With a total cost (acute hospital and outpatient costs) of BeF4,667,894,950 ($US126,159,323) per year in Belgium, proximal femoral neck fracture should be considered a major health economic problem and appropriate measures to prevent this disease should be rapidly undertaken.

[Bone-specific treatment design in the treatment of postmenopausal osteoporosis. Pharmaco-economic aspects]. / Les thérapeutiques à visée spécifiquement osseuse dans le traitement de l'ostéoporose postménopausique. Aspects pharmaco-économiques.

Fairly new economic evaluations were, so far, properly conducted in the field of prevention and treatment of osteoporosis. This lack of studies is likely to be related to the pathophysiology and the natural course of the disease, the small number of disease-specific instruments allowing the evaluation of quality of life changes following fractures and the frequent interaction of osteoporotic treatments with other body systems. Notwithstanding a lot of efforts have to be brought before economic evaluations in osteoporosis become a key determinant of Public Health strategies, it remains of prime interest to promote this type of research taking into account the importance of the social, human and economic burden of this disease.