References of "Hiligsmann, Mickaël"
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See detailSMA: REGISTRIES, BIOMARKERS & OUTCOME MEASURES: P.187 Systematic literature review of the economic burden and economic evaluations in spinal muscular atrophy
Dangouloff, Tamara ULiege; Servais, Laurent ULiege; Hiligsmann, Mickaël ULiege

in Neuromuscular Disorders (2020, October)

New treatments in spinal muscular atrophy (SMA) have led to a complete change in the pattern in the use of health care resources in this disease. Through all over the world, the very high cost of ... [more ▼]

New treatments in spinal muscular atrophy (SMA) have led to a complete change in the pattern in the use of health care resources in this disease. Through all over the world, the very high cost of innovative medication has led to public debates largely expressed in mainstream medias. We have systematically reviewed studies evaluating the cost of SMA and economic evaluations of spinal muscular atrophy. The review was conducted according to PRISMA guidelines and included original articles published between January 1, 1998 and March 2020. Seven studies reporting the cost of SMA were identified. The average annual costs of untreated SMA1 (including early onset and SMA before one year), were relatively similar across the different studies, ranging from $106,000 to $140,000 per year. On the other hand, the costs for SMA 2, 3 and 4 were mainly presented together (ranging from $23,000 to $115,000), despite a high heterogenicity in clinical conditions leading to very different health care resource consumption. Five economic evaluations were published between 2017 and 2020 and included innovative disease modifying medications. Three assessed the cost-effectiveness of nusinersen against standards of care, one of them two treatments (nusinersen and zolgensma) against standards of care and one compared Nusinersen and Zolgensma. All studies used a decision-analytic model to assess the cost- effectiveness and are based on same clinical trials involving a limited number of patients. Due to the extremely high cost of treatment, the incremental cost-effectiveness ratio of drugs versus no treatment is generally above $200,000, leading to no cost-effective results. In conclusion, all studies converge to demonstrate the significant economic cost of SMA, especially SMA1, but a better evaluation of the cost related to other forms is needed. A few economic evaluations suggest that drugs delivered in post-symptomatic phase at current prices are actually not cost-effective at commonly accepted cost-effectiveness threshold. No economic evaluation of newborn screening has yet been conducted. [less ▲]

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See detailSMA: REGISTRIES, BIOMARKERS & OUTCOME MEASURES: P.191 Preliminary data for the cost-effectiveness assessment of the newborn screening for SMA in Belgium
Dangouloff, Tamara ULiege; Servais, Laurent ULiege; Hiligsmann, Mickaël ULiege

in Neuromuscular Disorders (2020)

Neonatal screening is becoming increasingly important in the spinal muscular atrophy (SMA) landscape. Yet there is a growing set of evidences that early pre-symptomatic management is much more efficient ... [more ▼]

Neonatal screening is becoming increasingly important in the spinal muscular atrophy (SMA) landscape. Yet there is a growing set of evidences that early pre-symptomatic management is much more efficient than post- symptomatic treatment, there is however no information available on the cost-effectiveness of SMA newborn screening (NBS). Such health economic analysis is nevertheless very important to convince policy makers to allocate funds for NBS. We will present the health-economic data of pre-symptomatic and post-symptomatic treated patients in Belgium that will further be used to assess the cost-effectiveness of NBS. Between March 2018 and February 2020, screening was conducted among 71,000 newborns, among which 9 were detected with SMA. All but one identified patients were treated before the onset of symptoms: 5 with nusinersen (one was mildly symptomatic at the time of treatment), 2 with Zolgensma, 1 with Risdiplam and the last one to be determined. Survival, costs and quality of life of these 9 patients (aged between 10 days and 18 months) are currently prospectively collected. In addition, data from 3 additional asymptomatic patients who were siblings of affected children are also collected. Survival, health care resources consumption and quality of life data have also been collected on symptomatic treated and untreated patients. For untreated patients, we collected prospectively the data during two years in 81 patients (53 patients with SMA Type 2, 9 non-ambulant with SMA Type 3 and 19 ambulant with SMA Type 3). We are also collecting similar data prospectively in 30 symptomatic patients treated with nusinersen and 2 untreated patients, aged between 4 months and 60 years (9 patients with SMA 1, 14 patients with SMA 2, and 9 patients with SMA 3). Two-thirds of these patients already have at least 2 years of follow-up. Using these three sets of data, we are currently developing a model to assess the cost-effectiveness of newborn screening for SMA. We will present the preliminary results issued from this model. [less ▲]

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See detail244th ENMC International Workshop: Newborn screening in Spinal Muscular Atrophy May 10-12, 2019, Hoofdorp, The Netherlands
Dangouloff, Tamara ULiege; Burghes, Arthur; Bertini, Enrico et al

in Neuromuscular Disorders (2020), 30(1), 93-103

•Efficacy of new treatments in SMA is better in pre than in post-symptomatic patients •NBS is complementary of carriers screening, with different false negatives •Pilot projects of SMA NBS have started or ... [more ▼]

•Efficacy of new treatments in SMA is better in pre than in post-symptomatic patients •NBS is complementary of carriers screening, with different false negatives •Pilot projects of SMA NBS have started or are planned to start in several countries •Questions remain on SMN2 quantification and management of patients with 4 copies •We propose a strategy to launch an evidence-based approach for these patients [less ▲]

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See detailBest-worst scaling identified adequate statistical methods and literature search as the most important items of AMSTAR2 (A measurement tool to assess systematic reviews)
Leclercq, Victoria ULiege; Hiligsmann, Mickaël ULiege; Parisi, Gianni ULiege et al

in Journal of Clinical Epidemiology (2020), 128

Objective: To assess the relative importance of A MeaSurement Tool to Assess systematic Reviews 2 (AMSTAR2) items. Study design and setting: A best-worst scaling object case was conducted among a sample ... [more ▼]

Objective: To assess the relative importance of A MeaSurement Tool to Assess systematic Reviews 2 (AMSTAR2) items. Study design and setting: A best-worst scaling object case was conducted among a sample of experts in the field of systematic reviews (SRs) and meta-analyses (MAs). Respondents were asked in a series of 15 choice tasks to choose the most and the least important item from a set of four items from the master list, which included the 16 AMSTAR2 items. Hierarchical Bayes analysis was used to generate the relative importance score for each item. Results: The most important items highlighted by our 242 experts to conduct overview of reviews and critically assess SRs/MAs were the appropriateness of statistical analyses and adequacy of the literature search, followed by items regarding the assessment of risk of bias, the research protocol, and the assessment of heterogeneity (relative importance score >6.5). Items related to funding sources and the assessment of study selection and data extraction in duplicate were rated as least important. Conclusion: Although all AMSTAR2 items can be considered as important, our results highlighted the importance of keeping the two items (the appropriateness of statistical analyses and the adequacy of the literature search) among the critical items proposed by AMSTAR2 to critically appraise SRs/MAs. [less ▲]

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See detailRecommendations 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
Hiligsmann, Mickaël ULiege; Reginster, Jean-Yves ULiege; Tosteson, A.N.A. et al

in Osteoporosis International (2019), 30(1), 45-57

Summary 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 ... [more ▼]

Summary 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. [less ▲]

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See detailCost-effectiveness of vitamin D and calcium supplementation in the treatment of elderly women and men with osteoporosis.
Hiligsmann, Mickaël ULiege; Ben Sedrine, Wafa; Bruyère, Olivier ULiege et al

in European Journal of Public Health (2015), 25(1), 20-25

BACKGROUND: The supplementation with vitamin D and calcium has been recommended for elderly, specifically those with increased risk of fractures older than 65 years. This study aims to assess the cost ... [more ▼]

BACKGROUND: The supplementation with vitamin D and calcium has been recommended for elderly, specifically those with increased risk of fractures older than 65 years. This study aims to assess the cost-effectiveness of vitamin D and calcium supplementation in elderly women and men with osteoporosis and therefore to assess if this recommendation is justified in terms of cost-effectiveness. METHODS: A validated model for economic evaluations in osteoporosis was used to estimate the cost per quality-adjusted life-year (QALY) gained of vitamin D/calcium supplementation compared with no treatment. The model was populated with cost and epidemiological data from a Belgian health-care perspective. Analyses were conducted in women and men with a diagnosis of osteoporosis (i.e. bone mineral density T-score </=-2.5). A literature search was conducted to describe the efficacy of vitamin D and calcium in terms of fracture risk reduction. RESULTS: The cost per QALY gained of vitamin D/calcium supplementation was estimated at euro40 578 and euro23 477 in women and men aged 60 years, respectively. These values decreased to euro7912 and euro10 250 at the age of 70 years and vitamin D and calcium supplementation was cost-saving at the age of 80 years, meaning that treatment cost was less than the costs of treating osteoporotic fractures of the no-treatment group. CONCLUSION: This study suggests that vitamin D and calcium supplementation is cost-effective for women and men with osteoporosis aged over 60 years. From an economic perspective, vitamin D and calcium should therefore be administrated in these populations including those also taking other osteoporotic treatments. [less ▲]

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See detailCost-effectiveness of dairy products supplemented with vitamin D in the prevention of osteoporotic fractures
Ethgen, Olivier ULiege; Hiligsmann, Mickaël ULiege; Bruyère, Olivier ULiege et al

in Osteoporosis International (2015), 26(S1), 372-373

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See detailA Systematic Review of Cost-Effectiveness Analyses of Drugs for Postmenopausal Osteoporosis.
Hiligsmann, Mickaël ULiege; Evers, Silvia M.; Ben Sedrine, Wafa et al

in PharmacoEconomics (2015), 33(3), 205-224

BACKGROUND: Given the limited availability of healthcare resources and the recent introduction of new anti-osteoporosis drugs, the interest in the cost effectiveness of drugs in postmenopausal ... [more ▼]

BACKGROUND: Given the limited availability of healthcare resources and the recent introduction of new anti-osteoporosis drugs, the interest in the cost effectiveness of drugs in postmenopausal osteoporosis remains and even increases. OBJECTIVE: This study aims to identify all recent economic evaluations on drugs for postmenopausal osteoporosis, to critically appraise the reporting quality, and to summarize the results. METHODS: A literature search using Medline, the National Health Service Economic Evaluation database and the Cost-Effectiveness Analysis Registry was undertaken to identify original articles published between January 1, 2008 and December 31, 2013. Studies that assessed cost effectiveness of drugs in postmenopausal osteoporosis were included. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement was used to assess the quality of reporting of these articles. RESULTS: Of 1,794 articles identified, 39 studies fulfilled the inclusion criteria. They were conducted in 14 different countries and nine active interventions were assessed. When compared with no treatment, active osteoporotic drugs were generally cost effective in postmenopausal women aged over 60-65 years with low bone mass, especially those with prior vertebral fractures. Key drivers of cost effectiveness included individual fracture risk, medication adherence, selected comparators and country-specific analyses. Quality of reporting varied between studies with an average score of 17.9 out of 24 (range 7-21.5). CONCLUSION: This review found a substantial number of published cost-effectiveness analyses of drugs in osteoporosis in the last 6 years. Results and critical appraisal of these articles can help decision makers when prioritizing health interventions and can inform the development of future economic evaluations. [less ▲]

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See detailEconomic evaluation of an osteoporosis screening campaign: using FRAX as a prescreening tool
Hiligsmann, Mickaël ULiege; Ben Sedrine, Wafa ULiege; Bruyère, Olivier ULiege et al

in Osteoporosis International (2014), 25(2), 38-39

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See detailA reference case for economic evaluations in osteoarthritis: An expert consensus article from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO).
Hiligsmann, Mickaël ULiege; Cooper, Cyrus; Guillemin, Francis et al

in Seminars in Arthritis and Rheumatism (2014), 44

BACKGROUND: General recommendations for a reference case for economic studies in rheumatic diseases were published in 2002 in an initiative to improve the comparability of cost-effectiveness studies in ... [more ▼]

BACKGROUND: General recommendations for a reference case for economic studies in rheumatic diseases were published in 2002 in an initiative to improve the comparability of cost-effectiveness studies in the field. Since then, economic evaluations in osteoarthritis (OA) continue to show considerable heterogeneity in methodological approach. OBJECTIVES: To develop a reference case specific for economic studies in OA, including the standard optimal care, with which to judge new pharmacologic and non-pharmacologic interventions. METHODS: Four subgroups of an ESCEO expert working group on economic assessments (13 experts representing diverse aspects of clinical research and/or economic evaluations) were charged with producing lists of recommendations that would potentially improve the comparability of economic analyses in OA: outcome measures, comparators, costs and methodology. These proposals were discussed and refined during a face-to-face meeting in 2013. They are presented here in the format of the recommendations of the recently published Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, so that an initiative on economic analysis methodology might be consolidated with an initiative on reporting standards. RESULTS: Overall, three distinct reference cases are proposed, one for each hand, knee and hip OA; with diagnostic variations in the first two, giving rise to different treatment options: interphalangeal or thumb-based disease for hand OA and the presence or absence of joint malalignment for knee OA. A set of management strategies is proposed, which should be further evaluated to help establish a consensus on the "standard optimal care" in each proposed reference case. The recommendations on outcome measures, cost itemisation and methodological approaches are also provided. CONCLUSIONS: The ESCEO group proposes a set of disease-specific recommendations on the conduct and reporting of economic evaluations in OA that could help the standardisation and comparability of studies that evaluate therapeutic strategies of OA in terms of costs and effectiveness. [less ▲]

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See detailErratum to: Management of osteoporosis of the oldest old
Rizzoli, R; Branco, J; Brandi, ML et al

in Osteoporosis International (2014), 25

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See detailManagement of osteoporosis of the oldest old.
Rizzoli, R.; Branco, J.; Brandi, M.-L. et al

in Osteoporosis International (2014), 25

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 ... [more ▼]

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. [less ▲]

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See detailPatients' preferences for osteoporosis drug treatment: a discrete-choice experiment.
Hiligsmann, Mickaël ULiege; Dellaert, Benedict G.; Dirksen, Carmen D. et al

in Arthritis Research and Therapy (2014), 16(1), 36

INTRODUCTION: The patient's perspective is becoming increasingly important in clinical and policy decisions. In this study, we aimed to evaluate the preferences of patients with, or at risk of ... [more ▼]

INTRODUCTION: The patient's perspective is becoming increasingly important in clinical and policy decisions. In this study, we aimed to evaluate the preferences of patients with, or at risk of, osteoporosis for medication attributes, and to establish how patients trade between these attributes. METHODS: A discrete choice experiment survey was designed and patients were asked to choose between two hypothetical unlabelled drug treatments (and an opt-out option) that vary in five attributes: efficacy in reducing the risk of fracture, type of potential common side-effects, mode and frequency of administration and out-of-pocket costs. An efficient experimental design was used to construct the treatment option choice sets and a mixed logit panel data model was used to estimate patients' preferences and trade-offs between attributes. RESULTS: A total of 257 patients with, or at risk of, osteoporosis completed the experiment. As expected, patients preferred treatment with higher effectiveness and lower cost. They also preferred either an oral monthly tablet or 6-month subcutaneous injection above weekly oral tablets, 3-month subcutaneous, 3-month intravenous or yearly intravenous injections. Patients disliked being at risk of gastro-intestinal disorders more than being at risk of skin reactions and flu-like symptoms. There was significant variation in preferences across the sample for all attributes except subcutaneous injection. CONCLUSIONS: This study revealed that osteoporotic patients preferred 6-month subcutaneous injection and oral monthly tablet, and disliked gastro-intestinal disorders. Moreover, patients were willing to pay a personal contribution or to trade treatment efficacy for better levels of other attributes. Preferences for treatment attributes varied across patients and this highlights the importance of clinical decision-making taking individual preferences into account to improve osteoporosis care. [less ▲]

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See detailPreferences of patients for osteoporosis drug treatment: a cross-european discrete choice experiment
Hiligsmann, Mickaël ULiege; Dellaert, BG; Dirksen, CD et al

in Osteoporosis International (2014), 25(2), 227-228

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See detailRisk of hip fracture in community-dwelling and institutionalized osteoporotic patients: A 3-year study.
Bruyère, Olivier ULiege; Hiligsmann, Mickaël ULiege; Zegels, Brigitte ULiege et al

in International Journal of Gerontology (2013), 7(3), 167-70

Background and aims: It has been previously suggested that the incidence of hip fracture is higher among <br />people living in nursing homes than among community-dwelling people. However, it is not clear ... [more ▼]

Background and aims: It has been previously suggested that the incidence of hip fracture is higher among <br />people living in nursing homes than among community-dwelling people. However, it is not clear <br />whether this is a consequence of nursing home residency or of the greater age of the residents. We have <br />examined the relationship between the place of residence and hip fracture incidence, in a prospective 3- <br />year study. <br />Methods: Women from nine countries included in this study were part of the placebo group of <br />a randomized controlled trial having assessed the long-term effect of a new antiosteoporotic drug. All <br />women were osteoporotic and received placebo and vitamin D during the 3 years of follow-up. All the <br />institutionalized (nursing home, medical house) women (n ¼ 217) were included in this post hoc analysis <br />and three noninstitutionalized age- and country-matched controls were included (n ¼ 651). <br />Results: The mean (and standard deviation) age of the patients was 80.4 (5.6) years in the institutionalized <br />women and 80.2 (5.8) years in the noninstitutionalized women (p ¼ 0.87). After 3 years of followup, <br />37 fractures occurred: 12 (5.5%) in institutionalized women and 25 (3.8%) in noninstitutionalized <br />women. The difference between the two groups was not statistically significant (p ¼ 0.29). After <br />controlling for age, body mass index, femoral neck bone mineral density and prevalent nonvertebral <br />fracture, the residence status of the patient (institutionalized vs. noninstitutionalized) was not significantly <br />associated with hip fracture incidence (p ¼ 0.63). <br />Conclusions: We suggest that living in an institutionalized place is not an independent risk factor for hip <br />fracture for osteoporotic women receiving calcium and vitamin D. [less ▲]

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See detailComparison 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
Bruyère, Olivier ULiege; Fossi, Martin; Zegels, Brigitte ULiege et al

in Rheumatology International (2013), 33(4), 973-8

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 ... [more ▼]

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. [less ▲]

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See detailCost-effectiveness of vitamin D and calcium supplementation in the treatment of postmenopausal women
Hiligsmann, Mickaël ULiege; Ben Sedrine, Wafa ULiege; Rabenda, Véronique ULiege et al

in Osteoporosis International (2013, April), 24(Suppl.1), 198

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See detailHealth economics in osteoarthritis
Hiligsmann, Mickaël ULiege; Cooper, Cyrus; Arden, Nigel et al

in Osteoporosis International (2013, April), 24(Suppl.1), 79-80

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