An Assessment of the Toulouse Saint Louis University Mini Falls Assessment Tool to Predict Incident Falls among Older Adults Residing in Nursing Homes: A 6-Month Prospective Study.

OBJECTIVES: Toulouse Saint Louis University Mini Falls Assessment (TSLUMFA) tool has been designed to predict falls. It was initially validated in a geriatric clinic in 2018. The primary objective was to evaluate the predictive capacity of the TSLUMFA for incident falls in older adults residing in nursing homes. The secondary objective was to determine the TSLUMFA optimal cut-off value identifying those older adults with a high-risk of falling. SETTINGS: A longitudinal study was carried out over a period of six months. PARTICIPANTS: 93 older adults residing in nursing homes were evaluated for the present study. MEASUREMENTS: The TSLUMFA (made up of 7 criteria) was administered at baseline, and incident falls were recorded based on a registry of falls. Comparisons of TSLUMFA scores between fallers and non-fallers were performed using the U Mann-Whitney test or Chi². Correlation between the total TSLUMFA score (/30 points) and incident fall(s) was explored using the Cox proportional hazard model. ROC analysis enabled an optimal cut-off value to be established to identify those adults at the highest-risk of falling. RESULTS: In the study, 93 older adults (61.3% women) with a median age of 80 (69-87) years were included. The median total TSLUMFA score was 21 (19-24.5) points. During the 6-month study period, 38 subjects (40.9%) experienced at least one fall. The total TSLUMFA score in older adults with incident fall(s) was significantly lower than in those who did not fall (20 (15.75-22.25) points versus 23 (20-25) points and a p-value of <0.001). For each 1-point higher score at the total TSLUMFA a 9% less chance of falling was observed during the study period (p-value = 0.006). The AUC was 0.736 (95%CI: 0.617-0.822) and p-value <0.001, clearly demonstrating its interesting performance as a screening tool. A score of ≤ 21 points was identified as the optimal cut-off to identify those older adults at a higher-risk of falling. CONCLUSION: The TSLUMFA performed well and successfully identified older adults with a high risk of falling in a nursing home setting. Further comparisons with existing tools are warranted.

Assessment of Cardiovascular Safety of Anti-Osteoporosis Drugs.

The incidence of osteoporosis and cardiovascular disease increases with age, and there are potentially shared mechanistic associations between the two conditions. It is therefore highly relevant to understand the cardiovascular implications of osteoporosis medications. These are presented in this narrative review. Calcium supplementation could theoretically cause atheroma formation via calcium deposition, and in one study was found to be associated with myocardial infarction, but this has not been replicated. Vitamin D supplementation has been extensively investigated for cardiac benefit, but no consistent effect has been found. Despite findings in the early 21st century that menopausal hormone therapy was associated with coronary artery disease and venous thromboembolism (VTE), this therapy is now thought to be potentially safe (from a cardiac perspective) if started within the first 10 years of the menopause. Selective estrogen receptor modulators (SERMs) are associated with increased risk of VTE and may be related to fatal strokes (a subset of total strokes). Bisphosphonates could theoretically provide protection against atheroma. However, data from randomised trials and observational studies have neither robustly supported this nor consistently demonstrated the potential association with atrial fibrillation. Denosumab does not appear to be associated with cardiovascular disease and, although parathyroid hormone analogues are associated with palpitations and dizziness, no association with a defined cardiovascular pathology has been demonstrated. Finally, romosozumab has been shown to have a possible cardiovascular signal, and therefore post-market surveillance of this therapy will be vital.

Determinants, consequences and potential solutions to poor adherence to anti-osteoporosis treatment: results of an expert group meeting organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the International Osteoporosis Foundation (IOF).

Many patients at increased risk of fractures do not take their medication appropriately, resulting in a substantial decrease in the benefits of drug therapy. Improving medication adherence is urgently needed but remains laborious, given the numerous and multidimensional reasons for non-adherence, suggesting the need for measurement-guided, multifactorial and individualized solutions. INTRODUCTION: Poor adherence to medications is a major challenge in the treatment of osteoporosis. This paper aimed to provide an overview of the consequences, determinants and potential solutions to poor adherence and persistence to osteoporosis medication. METHODS: A working group was organized by the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal diseases (ESCEO) to review consequences, determinants and potential solutions to adherence and to make recommendations for practice and further research. A systematic literature review and a face-to-face experts meeting were undertaken. RESULTS: Medication non-adherence is associated with increased risk of fractures, leading to a substantial decrease in the clinical and economic benefits of drug therapy. Reasons for non-adherence are numerous and multidimensional for each patient, depending on the interplay of multiple factors, suggesting the need for multifactorial and individualized solutions. Few interventions have been shown to improve adherence or persistence to osteoporosis treatment. Promising actions include patient education with counselling, adherence monitoring with feedback and dose simplification including flexible dosing regimen. Recommendations for practice and further research were also provided. To adequately manage adherence, it is important to (1) understand the problem (initiation, implementation and/or persistence), (2) to measure adherence and (3) to identify the reason of non-adherence and fix it. CONCLUSION: These recommendations are intended for clinicians to manage adherence of their patients and to researchers and policy makers to design, facilitate and appropriately use adherence interventions.

Impact of frailty status on the cost of drugs and dietary supplements prescribed to nursing home residents: the SENIOR cohort.

BACKGROUND: The financial impact associated with drug consumption has been poorly investigated among frail subjects and, specifically, in nursing home settings. AIMS: To determine the association of the average monthly cost of the drugs and dietary supplements consumed by nursing home residents with their frailty status. METHODS: This is an analysis of the first follow-up year of the SENIOR cohort. All participants were classified into "frail" or "non-frail" categories according to Fried's criteria at baseline. Monthly bills from the pharmacy were analysed to determine the association between the average monthly cost of the drugs and dietary supplements consumed and frailty status. RESULTS: A sample of 87 residents (83.8 ± 9.33 years and 75.9% women) from the SENIOR cohort was included. The prevalence of frailty was 28%. The median number of medications consumed each day was 9 (6-12) (no difference between frail and non-frail subjects; p = 0.15). The overall median monthly cost was € 109.6, of which 49% was covered by Belgian social security and the remaining balance was paid by the patient. When comparing the drug expenses of the frail subjects and the non-frail subjects, the overall average monthly cost did not differ between the 2 groups (p = 0.057). Nevertheless, the expenditure remaining to be paid by the residents, after the Belgian social security intervention, was significantly higher among the frail residents (€ 65.7) than among the non-frail residents (€ 47.6; p = 0.017). CONCLUSIONS: Frailty status has an impact on the expenditures related to the consumption of drugs.

Recommendations for the conduct of economic evaluations in osteoporosis: outcomes of an experts' consensus meeting organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the US branch of the International Osteoporosis Foundation.

Economic evaluations are increasingly used to assess the value of health interventions, but variable quality and heterogeneity limit the use of these evaluations by decision-makers. These recommendations provide guidance for the design, conduct, and reporting of economic evaluations in osteoporosis to improve their transparency, comparability, and methodologic standards. INTRODUCTION: This paper aims to provide recommendations for the conduct of economic evaluations in osteoporosis in order to improve their transparency, comparability, and methodologic standards. METHODS: A working group was convened by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis to make recommendations for the design, conduct, and reporting of economic evaluations in osteoporosis, to define an osteoporosis-specific reference case to serve a minimum standard for all economic analyses in osteoporosis, to discuss methodologic challenges and initiate a call for research. A literature review, a face-to-face meeting in New York City (including 11 experts), and a review/approval by a larger group of experts worldwide (including 23 experts in total) were conducted. RESULTS: Recommendations on the type of economic evaluation, methods for economic evaluation, modeling aspects, base-case analysis and population, excess mortality, fracture costs and disutility, treatment characteristics, and model validation were provided. Recommendations for reporting economic evaluations in osteoporosis were also made and an osteoporosis-specific checklist was designed that includes items to report when performing an economic evaluation in osteoporosis. Further, 12 minimum criteria for economic evaluations in osteoporosis were identified and 12 methodologic challenges and need for further research were discussed. CONCLUSION: While the working group acknowledges challenges and the need for further research, these recommendations are intended to supplement general and national guidelines for economic evaluations, improve transparency, quality, and comparability of economic evaluations in osteoporosis, and maintain methodologic standards to increase their use by decision-makers.

Bone health assessment in older people with or without muscle health impairment.

This study investigated the relationship between muscle and bone status in elderly individuals. Our results suggested links between sarcopenia and osteoporosis; impairment in muscle status (i.e., muscle mass, muscle strength, and physical performance) is associated with deterioration in bone mass and texture subsequently leading to an increased risk of fracture. INTRODUCTION: Accumulating evidence has shown associations between sarcopenia and osteoporosis, but existing studies face inconsistencies in the clinical definition of both conditions. Thus, we sought to investigate bone health among older individuals with or without muscle health impairment. METHODS: We conducted an analysis of cross-sectional data available from the Sarcopenia and Physical Impairment with Advancing Age (SarcoPhAge) study. Sarcopenia was diagnosed according to the European Working Group on Sarcopenia in Older People (EWGSOP) (i.e., a low muscle mass plus either low muscle strength or low physical performance). Muscle mass and areal bone mineral density (aBMD) were determined using dual-energy X-ray absorptiometry (DEXA). Muscle strength was assessed using a hand dynamometer, and physical performance was assessed with the Short Physical Performance Battery test. Using the cutoff limits proposed by the EWGSOP, we have classified women in the "low SMI group" when its value was < 5.50 kg/m2, in the "low muscle strength group" when strength was < 20 kg, and in the "low physical performance group" when SPPB < 8 points. The thresholds of < 7.26 kg/m2 (for SMI), < 30 kg (for muscle strength), and SPPB < 8 points were used for men. The 10-year fracture risk was obtained using the FRAX® tool. Moreover, bone texture was determined using the trabecular bone score (TBS) method. RESULTS: The study sample consisted of 288 older subjects aged 74.7 ± 5.7 years, and 59.0% of the subjects were women. Sarcopenia was diagnosed in 43 individuals (14.9%), and osteoporosis was diagnosed in 36 subjects (12.5%). Moreover, aBMD values were, most of the time, lower in older men and women with muscle impairment (i.e., low muscle mass, low muscle strength, and low physical performance). For these subjects, we also noted a higher probability of fracture. When comparing bone quality, there were no significant differences in the TBS values between sarcopenic and non-sarcopenic older men and women or between those with low and high muscle mass. However, when controlling for confounders (i.e., age, BMI, number of co-morbidities, smoking status, and nutritional status), TBS values were lower in older women with low muscle strength (p = 0.04) and in older men with low physical performance (p = 0.01). CONCLUSIONS: Our study showed interrelationships between components of sarcopenia and osteoporosis, with older subjects with muscle impairment having poorer bone health.

The role of calcium supplementation in healthy musculoskeletal ageing : An expert consensus meeting of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the International Foundation for Osteoporosis (IOF).

The place of calcium supplementation, with or without concomitant vitamin D supplementation, has been much debated in terms of both efficacy and safety. There have been numerous trials and meta-analyses of supplementation for fracture reduction, and associations with risk of myocardial infarction have been suggested in recent years. In this report, the product of an expert consensus meeting of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the International Foundation for Osteoporosis (IOF), we review the evidence for the value of calcium supplementation, with or without vitamin D supplementation, for healthy musculoskeletal ageing. We conclude that (1) calcium and vitamin D supplementation leads to a modest reduction in fracture risk, although population-level intervention has not been shown to be an effective public health strategy; (2) supplementation with calcium alone for fracture reduction is not supported by the literature; (3) side effects of calcium supplementation include renal stones and gastrointestinal symptoms; (4) vitamin D supplementation, rather than calcium supplementation, may reduce falls risk; and (5) assertions of increased cardiovascular risk consequent to calcium supplementation are not convincingly supported by current evidence. In conclusion, we recommend, on the basis of the current evidence, that calcium supplementation, with concomitant vitamin D supplementation, is supported for patients at high risk of calcium and vitamin D insufficiency, and in those who are receiving treatment for osteoporosis.

[Combining microcredit, microinsurance, and the provision of health care can improve access to quality care in urban areas of Africa: Results of an experiment in the Bandalungwa health zone in Kinshasa, the Congo]. / Le couplage microcrédit/microassurance santé/offre de soins peut améliorer l'accessibilité aux soins de santé en milieu urbain africain Résultats d'une expérience menée dans la zone de santé de Bandalungwa à Kinshasa, Congo.

This study, based on a survey conducted in 2008, examines how combining microcredit, microinsurance, and health care provision can improve access to quality care in the health zone of Bandalungwa, in Kinshasa. The bivariate analysis showed a significant association between increased purchasing power and earnings (p = 0.001), between earnings and savings (p = 0.000), and between health insurance and improved access to health care. These results show that 68.8% of borrowers reported an increase in their purchasing power, of whom 82% reported profits. Those with savings were 24.7 times more likely to purchase health insurance than those without; and 72% of those who regularly made health insurance payments improved their access to care. Combining microcredit, health microinsurance, and health care can improve access to quality health care at lower cost. This suggests that health insurance could usefully be integrated into the primary health-care system.

Estimation of sarcopenia prevalence using various assessment tools.

BACKGROUND: Sarcopenia is defined as a progressive and generalized loss of muscle mass with either a loss of muscle strength or a loss of physical performance but there is no recommendation regarding the diagnostic tools that have to be used. In this study, we compared the prevalence of sarcopenia assessed using different diagnostic tools. METHODS: To measure muscle mass, muscle strength and physical performance, we used for each outcome two different diagnostic tools. For muscle mass, we used Dual Energy X-Ray Absorptiometry (DXA) and bio-electrical impedance analysis (BIA); for muscle strength, we used a hydraulic dynamometer and a pneumatic dynamometer; for physical performance we used the Short Physical Performance Battery test (SPPB test) and the walk speed. Eight diagnostic groups were hereby established. RESULTS: A total of 250 consecutive subjects were recruited in an outpatient clinic in Liège, Belgium. Estimated prevalence of sarcopenia varied from 8.4% to 27.6% depending on the method of diagnosis used. Regarding muscle mass, BIA systematically overestimated muscle mass compared to DXA (mean estimated prevalence with BIA=12.8%; mean prevalence with DXA=21%). For muscle strength, the pneumatic dynamometer diagnosed twice more sarcopenic subjects than the hydraulic dynamometer (mean estimated prevalence with PD=22.4%; mean estimated prevalence with HD=11.4%). Finally, no difference in prevalence was observed when the walking speed or the SPPB test was used. A weak overall kappa coefficient was observed (0.53), suggesting that the 8 methods of diagnosis are moderately concordant. CONCLUSION: Within the same definition of sarcopenia, prevalence of sarcopenia is highly dependent on the diagnostic tools used.

Mirabel: an integrated project for risk and cost/benefit analysis of peanut allergy.

Food allergy is a major public health issue. However, no regulatory measures exist when allergens are present at trace levels and the different risk components are poorly described. Thus, knowledge on exposure components such as the allergens present in foods and the consumption behaviour of allergic consumers and models to estimate the related risk need to be enriched. Mirabel proposes for the first time studying each risk component using an integrated approach in order to improve the quality of life of the allergic population. Field surveys were conducted in order to fill in the current gaps in unintentional allergen traces in food, allergic consumers' food behaviour, threshold doses of allergic reaction, allergy symptoms and severity. The aim is also to propose methodological and operational tools to quantify allergic risk, to test management scenarios and to produce a cost/benefit analysis. Medical data on the peanut allergies of 785 patients were collected in the MIRABEL survey and 443 patients answered the food consumption questionnaire. The population surveyed was mostly paediatric - 86% were children under 16 years of age, with a high percentage of males (60%). This project will generate tangible results on peanut allergen exposure and risk which could be used in future risk assessment work and particularly to provide science-based guidance to set up concentration limits for peanut traces on packages.

Management of osteoporosis of the oldest old.

UNLABELLED: This consensus article reviews the diagnosis and treatment of osteoporosis in geriatric populations. Specifically, it reviews the risk assessment and intervention thresholds, the impact of nutritional deficiencies, fall prevention strategies, pharmacological treatments and their safety considerations, the risks of sub-optimal treatment adherence and strategies for its improvement. INTRODUCTION: This consensus article reviews the therapeutic strategies and management options for the treatment of osteoporosis of the oldest old. This vulnerable segment (persons over 80 years of age) stands to gain substantially from effective anti-osteoporosis treatment, but the under-prescription of these treatments is frequent. METHODS: This report is the result of an ESCEO (European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis) expert working group, which explores some of the reasons for this and presents the arguments to counter these beliefs. The risk assessment of older individuals is briefly reviewed along with the differences between some intervention guidelines. The current evidence on the impact of nutritional deficiencies (i.e. calcium, protein and vitamin D) is presented, as are strategies to prevent falls. One possible reason for the under-prescription of pharmacological treatments for osteoporosis in the oldest old is the perception that anti-fracture efficacy requires long-term treatment. However, a review of the data shows convincing anti-fracture efficacy already by 12 months. RESULTS: The safety profiles of these pharmacological agents are generally satisfactory in this patient segment provided a few precautions are followed. CONCLUSION: These patients should be considered for particular consultation/follow-up procedures in the effort to convince on the benefits of treatment and to allay fears of adverse drug reactions, since poor adherence is a major problem for the success of a strategy for osteoporosis and limits cost-effectiveness.

Republished: Value of biomarkers in osteoarthritis: current status and perspectives.

Osteoarthritis affects the whole joint structure with progressive changes in cartilage, menisci, ligaments and subchondral bone, and synovial inflammation. Biomarkers are being developed to quantify joint remodelling and disease progression. This article was prepared following a working meeting of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis convened to discuss the value of biochemical markers of matrix metabolism in drug development in osteoarthritis. The best candidates are generally molecules or molecular fragments present in cartilage, bone or synovium and may be specific to one type of joint tissue or common to them all. Many currently investigated biomarkers are associated with collagen metabolism in cartilage or bone, or aggrecan metabolism in cartilage. Other biomarkers are related to non-collagenous proteins, inflammation and/or fibrosis. Biomarkers in osteoarthritis can be categorised using the burden of disease, investigative, prognostic, efficacy of intervention, diagnostic and safety classification. There are a number of promising candidates, notably urinary C-terminal telopeptide of collagen type II and serum cartilage oligomeric protein, although none is sufficiently discriminating to differentiate between individual patients and controls (diagnostic) or between patients with different disease severities (burden of disease), predict prognosis in individuals with or without osteoarthritis (prognostic) or perform so consistently that it could function as a surrogate outcome in clinical trials (efficacy of intervention). Future avenues for research include exploration of underlying mechanisms of disease and development of new biomarkers; technological development; the 'omics' (genomics, metabolomics, proteomics and lipidomics); design of aggregate scores combining a panel of biomarkers and/or imaging markers into single diagnostic algorithms; and investigation into the relationship between biomarkers and prognosis.

Value of biomarkers in osteoarthritis: current status and perspectives.

Osteoarthritis affects the whole joint structure with progressive changes in cartilage, menisci, ligaments and subchondral bone, and synovial inflammation. Biomarkers are being developed to quantify joint remodelling and disease progression. This article was prepared following a working meeting of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis convened to discuss the value of biochemical markers of matrix metabolism in drug development in osteoarthritis. The best candidates are generally molecules or molecular fragments present in cartilage, bone or synovium and may be specific to one type of joint tissue or common to them all. Many currently investigated biomarkers are associated with collagen metabolism in cartilage or bone, or aggrecan metabolism in cartilage. Other biomarkers are related to non-collagenous proteins, inflammation and/or fibrosis. Biomarkers in osteoarthritis can be categorised using the burden of disease, investigative, prognostic, efficacy of intervention, diagnostic and safety classification. There are a number of promising candidates, notably urinary C-terminal telopeptide of collagen type II and serum cartilage oligomeric protein, although none is sufficiently discriminating to differentiate between individual patients and controls (diagnostic) or between patients with different disease severities (burden of disease), predict prognosis in individuals with or without osteoarthritis (prognostic) or perform so consistently that it could function as a surrogate outcome in clinical trials (efficacy of intervention). Future avenues for research include exploration of underlying mechanisms of disease and development of new biomarkers; technological development; the 'omics' (genomics, metabolomics, proteomics and lipidomics); design of aggregate scores combining a panel of biomarkers and/or imaging markers into single diagnostic algorithms; and investigation into the relationship between biomarkers and prognosis.

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.

Vitamin D supplementation in elderly or postmenopausal women: a 2013 update of the 2008 recommendations from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO).

BACKGROUND: Vitamin D insufficiency has deleterious consequences on health outcomes. In elderly or postmenopausal women, it may exacerbate osteoporosis. SCOPE: There is currently no clear consensus on definitions of vitamin D insufficiency or minimal targets for vitamin D concentrations and proposed targets vary with the population. In view of the potential confusion for practitioners on when to treat and what to achieve, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) convened a meeting to provide recommendations for clinical practice, to ensure the optimal management of elderly and postmenopausal women with regard to vitamin D supplementation. FINDINGS: Vitamin D has both skeletal and extra-skeletal benefits. Patients with serum 25-hydroxyvitamin D (25-(OH)D) levels <50 nmol/L have increased bone turnover, bone loss, and possibly mineralization defects compared with patients with levels >50 nmol/L. Similar relationships have been reported for frailty, nonvertebral and hip fracture, and all-cause mortality, with poorer outcomes at <50 nmol/L. CONCLUSION: The ESCEO recommends that 50 nmol/L (i.e. 20 ng/mL) should be the minimal serum 25-(OH)D concentration at the population level and in patients with osteoporosis to ensure optimal bone health. Below this threshold, supplementation is recommended at 800 to 1000 IU/day. Vitamin D supplementation is safe up to 10,000 IU/day (upper limit of safety) resulting in an upper limit of adequacy of 125 nmol/L 25-(OH)D. Daily consumption of calcium- and vitamin-D-fortified food products (e.g. yoghurt or milk) can help improve vitamin D intake. Above the threshold of 50 nmol/L, there is no clear evidence for additional benefits of supplementation. On the other hand, in fragile elderly subjects who are at elevated risk for falls and fracture, the ESCEO recommends a minimal serum 25-(OH)D level of 75 nmol/L (i.e. 30 ng/mL), for the greatest impact on fracture.

Comparison of the proportion of patients potentially treated with an anti-osteoporotic drug using the current criteria of the Belgian national social security and the new suggested FRAX criteria.

To assess the number of anti-osteoporosis treatments that would be reimbursed by the Belgian social security if either FRAX or the current criteria were used to determine access to reimbursement. This is a retrospective study based on data from 1,000 women randomly selected from an outpatient hospital specialized in bone metabolism in Belgium. Proportions of potentially refunded treatments between FRAX and current criteria were compared. Out of the 1,000 women files, 890 have sufficient information to assess FRAX. In Belgium, current criteria include a bone mineral density (BMD) T score below -2.5 at the lumbar spine, the femoral neck or the total hip and/or at least a prevalent vertebral fracture. Using these criteria, 167 women (18.8 %) would have access to reimbursement. Using the criteria based on the validated Belgian FRAX tool, only 116 women (13.0 %) would have access to reimbursement, meaning that access to reimbursement based on FRAX criteria would reduce by 30 % the anti-osteoporosis drug expenses covered by the national social security. Interestingly, only 65 women out of the 116 (56.0 %) selected with the FRAX criteria were also selected with the current criteria of the national social security. A substantial proportion of individuals that would potentially receive a reimbursement for their treatment using the FRAX criteria do not have access to any refund for their treatment with the current criteria. Since patients identified with the FRAX tool are those with the highest risk profile for future fractures, reappraisals of treatment reimbursement guidelines are expected in Belgium.

Health claims assessment in the field of joint and cartilage: a consensus viewpoint of the Group for the Respect of Ethics and Excellence in Science.

INTRODUCTION: In 2006, the European Parliament and Council issued a regulation (No. 1924/2006) for the nutrition and health claims made on foods, including food supplements. According to the regulation, the use of nutrition and health claims shall only be permitted if the substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect. In the field of joint and cartilage health, there is no clear scientific-based definition of the nature of such a beneficial nutritional or physiological effect. The objective of this paper is to scientifically define the possible content of health claims related to joint and cartilage health and to provide scientific guidelines for the design of clinical studies which need to be adopted to substantiate such health claims. METHODS: Literature review up to September 2011 followed by a consensus expert discussion organized by the Group for the Respect of Ethics and Excellence in Science (GREES). RESULTS: In line with the general principles of the PASSCLAIM and the Codex recommendations, the GREES identified four acceptable health claims related to joint and cartilage health based on the effects on discomfort, joint and cartilage structural integrity or risk factors for joint and cartilage diseases. The GREES considers that randomized controlled trials on a relevant outcome is the best design to assess health claims. Moreover, animal studies could also be of interest to substantiate some health claims, to assess the clinical relevance of endpoints used in human studies or to extrapolate data obtained in patients to the target (apparently) healthy population. CONCLUSION: According to the methodology and biomarkers used in the study and whether or not additional animal studies are provided to support the claim, various health claims can be acceptable in the field of joint and cartilage health.

Assessment of health claims in the field of bone: a view of the Group for the Respect of Ethics and Excellence in Science (GREES).

UNLABELLED: Health claims for food products in Europe are permitted if the nutrient has been shown to have a beneficial nutritional or physiological effect. This paper defines health claims related to bone health and provides guidelines for the design and the methodology of clinical studies to support claims. INTRODUCTION: Regulation (EC) no. 1924/2006 on nutrition and health claims targeting food products was introduced in Europe stating that health claims shall only be permitted if the substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect. The objective of this paper is to define health claims related to bone health and to provide guidelines for the design and the methodology of clinical studies which need to be adopted to assert such health claims. METHODS: Literature review followed by a consensus discussion during two 1-day meetings organized by the Group for the Respect of Ethics and Excellence in Science (GREES). RESULTS: The GREES identified six acceptable health claims related to bone health based on the potential of food products to show an effect on either the bioavailability of calcium or osteoclast regulatory proteins or bone turnover markers or bone mineral density or bone structure or fracture incidence. The GREES considers that well-designed human randomized controlled trial on a relevant outcome is the best design to assess health claims. The substantiation of health claim could also be supported by animal studies showing either an improvement in bone strength with the food product or showing the relationship between changes induced by the food product on a surrogate marker and changes in bone strength. CONCLUSION: The consensus reached is that the level of health claim may differ according to the surrogate endpoint used and on additional animal studies provided to support the claim.

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

UNLABELLED: A country-specific FRAX® model was developed from the epidemiology of fracture and death in Belgium. Fracture probabilities were identified that corresponded to currently accepted reimbursement thresholds. INTRODUCTION: The objective of this study was to evaluate a Belgian version of the WHO fracture risk assessment (FRAX®) tool to compute 10-year probabilities of osteoporotic fracture in men and women. A particular aim was to determine fracture probabilities that corresponded to the reimbursement policy for the management of osteoporosis in Belgium and the clinical scenarios that gave equivalent fracture probabilities. METHODS: Fracture probabilities were computed from published data on the fracture and death hazards in Belgium. Probabilities took account of age, sex, the presence of clinical risk factors and femoral neck bone mineral density (BMD). Fracture probabilities were determined that were equivalent to intervention (reimbursement) thresholds currently used in Belgium. RESULTS: Fracture probability increased with age, lower BMI, decreasing BMD T-score and all clinical risk factors used alone or combined. The 10-year probabilities of a major osteoporosis-related fracture that corresponded to current reimbursement guidelines ranged from approximately 7.5% at the age of 50 years to 26% at the age of 80 years where a prior fragility fracture was used as an intervention threshold. For women at the threshold of osteoporosis (femoral neck T-score = -2.5 SD), the respective probabilities ranged from 7.4% to 15%. Several combinations of risk-factor profiles were identified that gave similar or higher fracture probabilities than those currently accepted for reimbursement in Belgium. CONCLUSIONS: The FRAX® tool has been used to identify possible thresholds for therapeutic intervention in Belgium, based on equivalence of risk with current guidelines. The FRAX® model supports a shift from the current DXA-based intervention strategy, towards a strategy based on fracture probability of a major osteoporotic fracture that in turn may improve identification of patients at increased fracture risk. The approach will need to be supported by health economic analyses.