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See detailAn Updated Systematic Review of Cost‑Effectiveness Analyses of Drugs for Osteoporosis
Li, N.; Cornelissen, D.; Silverman, S. et al

in PharmacoEconomics (in press)

Background: Considering the heavy economic burden of osteoporotic fractures, the limits of healthcare resources, and the recent availability of new anti-osteoporosis drugs, there is continuing interest in ... [more ▼]

Background: Considering the heavy economic burden of osteoporotic fractures, the limits of healthcare resources, and the recent availability of new anti-osteoporosis drugs, there is continuing interest in economic evaluation studies of osteoporosis management strategies. Objectives This study aims to (1) systematically review recent economic evaluations of drugs for osteoporosis and (2) to apply an osteoporosis-specific guideline to critically appraise them. Methods: A literature search was undertaken using PubMed, EMBASE, National Health Service Economic Evaluation database, and the Cost-Effectiveness Analysis Registry to identify original articles containing economic evaluations of anti-osteoporosis drugs, published between 1 July, 2013 and 31 December, 2019. A recent European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases-International Osteoporosis Foundation (ESCEO-IOF) guideline for the conduct and reporting of economic evaluations in osteoporosis was used to assess the quality of included articles. Results: The database search retrieved 3860 records, of which 27 studies fulfilled the inclusion criteria. These studies were conducted in 15 countries; 12 active drugs were assessed, including various traditional pharmacological treatments such as bisphosphonates, raloxifene, strontium ranelate, denosumab, and teriparatide, and new agents such as abaloparatide, romosozumab, and gastro-resistant risedronate. Eight out of 12 studies that compared traditional oral bisphosphonates to other active interventions (denosumab, zoledronic acid, gastro-resistant risedronate, and teriparatide) suggested that the other active agents were generally cost-effective or dominant. Additionally, the cost-effectiveness of sequential therapy has recently been assessed and indications are that it can lead to extra health benefits (larger gains in quality-adjusted life-year). The key drivers of cost effectiveness included baseline fracture risk, drug effect on the risk of fracture, drug cost, and medication adherence/persistence. The current average score for quality assessment was 17 out of 25 (range 2–15); room for improvement was observed for most studies, which could potentially be explained by the fact that most studies were published prior to the osteoporosis-specific guideline. Greater adherence to guideline recommendations was expected for future studies. The quality of reporting was also suboptimal, especially with regard to treatment side effects, treatment effect after discontinuation, and medication adherence. Conclusions: This updated review provides an overview of recently published cost-effectiveness analyses. In comparison with a previous review, recent economic evaluations of anti-osteoporosis drugs were conducted in more countries and included more active drugs and sequential therapy as interventions/comparators. The updated economic evidence could help decision makers prioritize health interventions and the unmet/unreported quality issues indicated by the osteoporosis-specific guideline could be useful in improving the transparency, quality, and comparability of future economic evaluations in osteoporosis. [less ▲]

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See detailCost-effectiveness of FRAX®-based intervention thresholds for management of osteoporosis in Singaporean women
Chandran, M.; Ganesan, G.; Tan, K. B. et al

in Osteoporosis International (in press)

Summary: Cost-effectiveness analysis of FRAX® intervention thresholds (ITs) in Singaporean women > 50 years of age showed that generic alendronate was cost-effective at age-dependent major osteoporotic ... [more ▼]

Summary: Cost-effectiveness analysis of FRAX® intervention thresholds (ITs) in Singaporean women > 50 years of age showed that generic alendronate was cost-effective at age-dependent major osteoporotic fracture (MOF) IT from the ages of 65 years for both full and real-world adherence whilst hip fracture (HF) ITs were cost-effective from the ages of 60 and 65 years. Alendronate was cost-effective irrespective of age only at fixed MOF IT of 14% and HF IT of 3.5%. Introduction: FRAX®-based intervention thresholds (ITs) were recently identified for osteoporosis management in Singapore. This study aimed to assess the cost-effectiveness of ITs in Singaporean women over the age of 50 years. Methods: A validated Markov microsimulation model was used to estimate the lifetime healthcare costs (SGD2019) per quality-adjusted life-years (QALY) of generic alendronate compared with no treatment. Cost-effectiveness of age-dependent FRAX® major osteoporotic fracture (MOF) and hip fracture (HF) ITs was explored. In addition, ITs that would lead to cost-effectiveness were computed. Fracture incidence and cost data were obtained from the Ministry of Health and a previously published Singaporean study. A cost-effectiveness threshold of SGD 62,500/QALY gained was used, based conservatively on 0.7 times the Singapore GDP per capita. Results: Generic alendronate was shown to be cost-effective at MOF ITs from the ages of 65 years, while HF ITs were cost-effective from the ages of 60 and 65 years, assuming full and real-world adherence, respectively. A 14% MOF and a 3.5% HF ITs were required for alendronate to be cost-effective above 50 years. Conclusion: This study suggests that the treatment of Singaporean women with alendronate is cost-effective at age-dependant FRAX® intervention thresholds at 65 years and older. Furthermore, identifying women at any age above 50 years with a 10-year risk of MOF or HF of 14% or 3.5% would lead to efficient use of resources. Cost-effective access to therapy for patients at high fracture probability based on FRAX® could contribute to reduce the growing burden of osteoporotic fractures in Singapore. © 2020, The Author(s). [less ▲]

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See detailIs there a role for menopausal hormone therapy in the management of postmenopausal osteoporosis?
Rozenberg, S.; Al-Daghri, N.; Aubertin-Leheudre, M. et al

in Osteoporosis International (in press)

We provide an evidence base and guidance for the use of menopausal hormone therapy (MHT) for the maintenance of skeletal health and prevention of future fractures in recently menopausal women. Despite ... [more ▼]

We provide an evidence base and guidance for the use of menopausal hormone therapy (MHT) for the maintenance of skeletal health and prevention of future fractures in recently menopausal women. Despite controversy over associated side effects, which has limited its use in recent decades, the potential role for MHT soon after menopause in the management of postmenopausal osteoporosis is increasingly recognized. We present a narrative review of the benefits versus risks of using MHT in the management of postmenopausal osteoporosis. Current literature suggests robust anti-fracture efficacy of MHT in patients unselected for low BMD, regardless of concomitant use with progestogens, but with limited evidence of persisting skeletal benefits following cessation of therapy. Side effects include cardiovascular events, thromboembolic disease, stroke and breast cancer, but the benefit-risk profile differs according to the use of opposed versus unopposed oestrogens, type of oestrogen/progestogen, dose and route of delivery and, for cardiovascular events, timing of MHT use. Overall, the benefit-risk profile supports MHT treatment in women who have recently (< 10 years) become menopausal, who have menopausal symptoms and who are less than 60 years old, with a low baseline risk for adverse events. MHT should be considered as an option for the maintenance of skeletal health in women, specifically as an additional benefit in the context of treatment of menopausal symptoms, when commenced at the menopause, or shortly thereafter, in the context of a personalized benefit-risk evaluation. © 2020, The Author(s). [less ▲]

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See detailHighly purified chondroitin sulfate: a literature review on clinical efficacy and pharmacoeconomic aspects in osteoarthritis treatment
Reginster, Jean-Yves ULiege; Veronese, N.

in Aging Clinical and Experimental Research (in press)

Osteoarthritis (OA) is the most prevalent musculoskeletal disease and a major cause of negative relevant outcomes, associated with an ever-increasing societal burden. Pharmaceutical-grade chondroitin ... [more ▼]

Osteoarthritis (OA) is the most prevalent musculoskeletal disease and a major cause of negative relevant outcomes, associated with an ever-increasing societal burden. Pharmaceutical-grade chondroitin sulfate (CS) was repeatedly reported to reduce pain and improve function in patients with OA. This article aims to review the evidence for the role of highly purified (hp) CS (Condrosulf®, IBSA) in the treatment of OA. We collected and reported evidence concerning (1) efficacy of hpCS 800 mg/day in the treatment of OA affecting the knee, hand and hip; (2) efficacy and safety of hpCS 1200 mg/day also in the oral gel formulation; (3) the safety profile of hpCS; (4) the difference of hpCS and pharmaceutical-grade formulations versus food supplements; (5) pharmacoeconomic added value of hpCS. The data support that hpCS is an effective and safe treatment of OA, with its effect already evident at 30 days; in addition, its beneficial action is prolonged, being maintained for at least 3 months after the drug is discontinued. Full safety reports’ analyses confirm that CS is safe to use and has almost no side effects, in particular, it showed better gastrointestinal tolerance if compared with non-steroidal anti-inflammatory drugs (NSAIDs). Moreover, the therapeutic strategy has proved to be cost-effective: treatment with CS reduced the use of NSAIDs and their side effects. © 2020, The Author(s). [less ▲]

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See detailMortality in malnourished older adults diagnosed by ESPEN and GLIM criteria in the SarcoPhAge study
Sanchez-Rodriguez, D.; Locquet, Médéa ULiege; Reginster, Jean-Yves ULiege et al

in Journal of Cachexia, Sarcopenia and Muscle (in press)

Background: The Global Leadership Initiative on Malnutrition (GLIM) criteria have been recently launched by consensus of the major nutrition societies. GLIM criteria are partly constructed on the previous ... [more ▼]

Background: The Global Leadership Initiative on Malnutrition (GLIM) criteria have been recently launched by consensus of the major nutrition societies. GLIM criteria are partly constructed on the previous definition of malnutrition developed by the European Society of Clinical Nutrition and Metabolism (ESPEN). We aimed to assess malnutrition according to the ESPEN and GLIM criteria at baseline and to determine the corresponding risk of mortality during a 4-year follow-up in community-dwelling older adults from the SarcoPhAge (Sarcopenia and Physical Impairment with advancing Age) study. The relationship between malnutrition and incidence of 4-year adverse health consequences (institutionalization, hospitalization, falls, and fractures) was assessed. Methods: This prospective population-based cohort was part of SarcoPhAge, which included 534 older adults in Belgium, followed up from 2013 to 2019. Community-dwelling healthy volunteers ≥65 years old were recruited. Mortality and adverse health consequences were collected annually by interview or phone call. Baseline malnutrition was defined according to the GLIM and ESPEN criteria. Agreement between the two definitions was reported by Cohen's kappa coefficient. Adjusted Cox regression and Kaplan–Meier survival curves were performed for malnutrition. Logistic regression was used for the other outcomes. Results: From 534 subjects in SarcoPhAge, the records for 411 participants (73.2 ± 6.05 years old; 55.7% women) had all the variables needed to apply the GLIM criteria. Prevalence of baseline malnutrition was 23.4% for GLIM and 7% for ESPEN criteria (k = 0.30, low agreement). The adjusted Cox regression showed a significant increased mortality risk according to malnutrition status as defined by the GLIM [adjusted hazard ratio = 4.41 (95% confidence interval: 2.17–8.97)] and ESPEN [adjusted hazard ratio = 2.76 (95% confidence interval: 1.16–6.58)] criteria. Survival curves differed significantly between malnourished and non-malnourished groups, regardless of the definition used (log rank P < 0.001 for both). No association was found between baseline malnutrition according to these two criteria and 4-year risk of institutionalization, hospitalization, falls, or fractures (all P > 0.05). Conclusions: Malnutrition according to the GLIM criteria was associated with a 4.4-fold higher mortality risk, double that of the ESPEN criteria, during a 4-year follow-up. No association was found between malnutrition according to these two criteria and incidence of other health adverse consequences. GLIM criteria anticipate mortality and might guide interventions, with important implications for clinical practice and research. © 2020 The Authors. Journal of Cachexia, Sarcopenia and Muscle published by John Wiley & Sons Ltd on behalf of Society on Sarcopenia, Cachexia and Wasting Disorders [less ▲]

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See detailOutcome priorities for older persons with sarcopenia
Hiligsmann, M.; Beaudart, Charlotte ULiege; Bruyère, Olivier ULiege et al

in Journal of the American Directors Associations (in press)

Objectives: To evaluate patients’ preferences for sarcopenia outcomes. Design: Discrete-choice experiment (DCE) Setting and Participants: Community-dwelling individuals older than 65 years suffering from ... [more ▼]

Objectives: To evaluate patients’ preferences for sarcopenia outcomes. Design: Discrete-choice experiment (DCE) Setting and Participants: Community-dwelling individuals older than 65 years suffering from sarcopenia recruited in Belgium, France, Germany, Italy, Spain, and Switzerland, who visited the clinic and were cognitively able to understand and fill out the survey. Methods: In the DCE survey, participants were repetitively asked to choose which one of the 2 patients suffering from sarcopenia deserves treatment the most. The 2 patients presented different levels of risk for 5 preselected sarcopenia outcomes: quality of life, mobility, domestic activities, fatigue, and falls. The DCE included 12 choice sets. Mixed logit panel model was used to estimate patients’ preferences and latent class model was conducted to identify profiles of responses. Results: Atotal of 216 sarcopenic personswere included for the analysis (68%women;mean age 78 years). All 5 preselected sarcopenia outcomes were shown to be significant. Overall, the most important sarcopenia outcome was mobility (30%), followed by the ability to manage domestic activities (22%), the risk of falls (18%), fatigue (17%), and quality of life (14%). The latent class model identified 2 classes of respondents. In the first class (probability of 56%), participants valued mobility the most (42%), followed by the ability to manage domestic activities (23%) and risk of falls (17%). In the second class, fatiguewas the most important outcome (27%) followed by domestic activities (19%) and risk of falls (19%). No statistically significant associations between the latent classes and sociodemographic characteristics were found. Conclusions and Implications: This study suggests that all 5 preselected outcomes were important for sarcopenic older individuals. Overall, the most important outcomes were mobility and the ability to manage domestic activities, although variations in preferenceswere observed between respondents. This could help in incorporating patient preferences when designing appropriate solutions for individuals with sarcopenia. [less ▲]

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See detailOdanacatib for the treatment of postmenopausal osteoporosis: results of the LOFT multicenter, randomized, double-blind, placebo-controlled trial and LOFT Extension Study
McClung, M.R.; O'Donoghue, M.L.; Papapoulos, S.E. et al

in Lancet Diabetes and Endocrinology (in press)

Background: Odanacatib, a cathepsin K inhibitor, reduces bone resorption while maintaining bone formation. Previous work has shown that odanacatib increases bone mineral density in postmenopausal women ... [more ▼]

Background: Odanacatib, a cathepsin K inhibitor, reduces bone resorption while maintaining bone formation. Previous work has shown that odanacatib increases bone mineral density in postmenopausal women with low bone mass. We aimed to investigate the efficacy and safety of odanacatib to reduce fracture risk in postmenopausal women with osteoporosis. Methods: The Long-term Odanacatib Fracture Trial (LOFT) was a multicentre, randomised, double-blind, placebocontrolled, event-driven study at 388 outpatient clinics in 40 countries. Eligible participants were women aged at least 65 years who were postmenopausal for 5 years or more, with a femoral neck or total hip bone mineral density T-score between –2·5 and –4·0 if no previous radiographic vertebral fracture, or between –1·5 and –4·0 with a previous vertebral fracture. Women with a previous hip fracture, more than one vertebral fracture, or a T-score of less than –4·0 at the total hip or femoral neck were not eligible unless they were unable or unwilling to use approved osteoporosis treatment. Participants were randomly assigned (1:1) to either oral odanacatib (50 mg once per week) or matching placebo. Randomisation was done using an interactive voice recognition system after stratification for previous radiographic vertebral fracture, and treatment was masked to study participants, investigators and their staff, and sponsor personnel. If the study completed before 5 years of double-blind treatment, consenting participants could enrol in a double-blind extension study (LOFT Extension), continuing their original treatment assignment for up to 5 years from randomisation. Primary endpoints were incidence of vertebral fractures as assessed using radiographs collected at baseline, 6 and 12 months, yearly, and at final study visit in participants for whom evaluable radiograph images were available at baseline and at least one other timepoint, and hip and non-vertebral fractures adjudicated as being a result of osteoporosis as assessed by clinical history and radiograph. Safety was assessed in participants who received at least one dose of study drug. The adjudicated cardiovascular safety endpoints were a composite of cardiovascular death, myocardial infarction, or stroke, and new-onset atrial fibrillation or flutter. Individual cardiovascular endpoints and death were also assessed. LOFT and LOFT Extension are registered with ClinicalTrials.gov (number NCT00529373) and the European Clinical Trials Database (EudraCT number 2007-002693-66). Findings: Between Sept 14, 2007, and Nov 17, 2009, we randomly assigned 16 071 evaluable patients to treatment: 8043 to odanacatib and 8028 to placebo. After a median follow-up of 36·5 months (IQR 34·43–40·15) 4297 women assigned to odanacatib and 3960 assigned to placebo enrolled in LOFT Extension (total median follow-up 47·6 months, IQR 35·45–60·06). In LOFT, cumulative incidence of primary outcomes for odanacatib versus placebo were: radiographic vertebral fractures 3·7% (251/6770) versus 7·8% (542/6910), hazard ratio (HR) 0·46, 95% CI 0·40–0·53; hip fractures 0·8% (65/8043) versus 1·6% (125/8028), 0·53, 0·39–0·71; non-vertebral fractures 5·1% (412/8043) versus 6·7% (541/8028), 0·77, 0·68–0·87; all p<0·0001. Combined results from LOFT plus LOFT Extension for cumulative incidence of primary outcomes for odanacatib versus placebo were: radiographic vertebral fractures 4·9% (341/6909) versus 9·6% (675/7011), HR 0·48, 95% CI 0·42–0·55; hip fractures 1·1% (86/8043) versus 2·0% (162/8028), 0·52, 0·40–0·67; non-vertebral fractures 6·4% (512/8043) versus 8·4% (675/8028), 0·74, 0·66–0·83; all p<0·0001. In LOFT, the composite cardiovascular endpoint of cardiovascular death, myocardial infarction, or stroke occurred in 273 (3·4%) of 8043 patients in the odanacatib group versus 245 (3·1%) of 8028 in the placebo group (HR 1·12, 95% CI 0·95–1·34; p=0·18). New-onset atrial fibrillation or flutter occurred in 112 (1·4%) of 8043 patients in the odanacatib group versus 96 (1·2%) of 8028 in the placebo group (HR 1·18, 0·90–1·55; p=0·24). Odanacatib was associated with an increased risk of stroke (1·7% [136/8043] vs 1·3% [104/8028], HR 1·32, 1·02–1·70; p=0·034), but not myocardial infarction (0·7% [60/8043] vs 0·9% [74/8028], HR 0·82, 0·58–1·15; p=0·26). The HR for all-cause mortality was 1·13 (5·0% [401/8043] vs 4·4% [356/8028], 0·98–1·30; p=0·10).When data from LOFT Extension were included, the composite of cardiovascular death, myocardial infarction, or stroke occurred in significantly more patients in the odanacatib group than in the placebo group (401 [5·0%] of 8043 vs 343 [4·3%] of 8028, HR 1·17, 1·02–1·36; p=0·029, as did stroke (2·3% [187/8043] vs 1·7% [137/8028], HR 1·37, 1·10–1·71; p=0·0051). Interpretation: Odanacatib reduced the risk of fracture, but was associated with an increased risk of cardiovascular events, specifically stroke, in postmenopausal women with osteoporosis. Based on the overall balance between benefit and risk, the study’s sponsor decided that they would no longer pursue development of odanacatib for treatment of osteoporosis. [less ▲]

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See detailReview of the guideline of the American College of Physicians on the treatment of osteoporosis.
Kanis, J.A.; Cooper, C.; Rizzoli, R et al

in Osteoporosis International (in press)

Summary: This review, endorsed by the International Osteoporosis Foundation and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases ... [more ▼]

Summary: This review, endorsed by the International Osteoporosis Foundation and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases, summarizes several failings of the recent guidelines of the American College of Physicians (ACP) on the treatment of low bone density or osteoporosis to prevent fractures. Introduction: The ACP recently issued guidelines for the treatment of low bone density or osteoporosis to prevent fractures. Methods : Literature review and critical review of the ACP guidelines. Results :The guideline is lacking in scope due to the endorsement of treatment based on T-scores rather than fracture risk assessment and in failure to adequately consider anabolic therapies. Conclusions :The ACP guideline appears outdated. [less ▲]

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See detailFrench translation and validation of the Achilles Tendon Total Rupture Score "ATRS"
Buckinx, Fanny ULiege; Lecocq, Gaël; Bornheim, Stephen ULiege et al

in Foot and Ankle Surgery (2020), 26(6), 662-668

BACKGROUND: To provide a cross-cultural French adaptation of the Achille's Tendon Total Rupture Score (ATRS) and to assess its psychometric performances. METHOD: The ATRS questionnaire was first ... [more ▼]

BACKGROUND: To provide a cross-cultural French adaptation of the Achille's Tendon Total Rupture Score (ATRS) and to assess its psychometric performances. METHOD: The ATRS questionnaire was first translated and inter-culturally adapted into French according to international guidelines. Then, 95 subjects were recruited to complete the French version of the ATRS twice (2 weeks of interval). The SF-36 and VISA-A were used as comparative questionnaires. The psychometric properties of the questionnaire were evaluated (test-retest reliability, internal consistency, construct validity, floor/ceiling effects). RESULTS: Thetest-retest reliability was excellent (ICC of 0,966 (95% CI:0.644-0.879)) and the internal consistency very high (Cronbach's alpha of 0,98). The convergent and divergent construct validity were also confirmed. Finally, none of the subjects obtained the lowest score (0) or the maximal score (100) to the questionnaire. CONCLUSION: A valid and reliable French version of the ATRS is now available. [less ▲]

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See detailCross-cultural adaptation, translation, and validation of the functional assessment scale for acute hamstring injuries (FASH) questionnaire for French-speaking patients
Locquet, Médéa ULiege; Willems, Tom; Specque, Clément et al

in Disability and Rehabilitation (2020), 42(14), 2076-2082

Study design: This consisted of a translation and validation study. Background: Acute hamstring injury is a frequent muscle strain in sports that require high explosive strength, impulsion or running ... [more ▼]

Study design: This consisted of a translation and validation study. Background: Acute hamstring injury is a frequent muscle strain in sports that require high explosive strength, impulsion or running phases. Therefore, the Functional Assessment Scale for Hamstring Injury questionnaire was developed to assess pain, physical activity level and ability to perform various exercises in patients with hamstring injuries. The Functional Assessment Scale for Hamstring Injury questionnaire is currently available in English, German, and Greek. Objectives: The goal of this study was to provide a cross-culturally adapted French-translation of the FASH questionnaire and to assess its psychometric performance. Methods: The French-translation and cross-cultural adaptation process were based on international recommendations, following six rigorous steps: (a) two initial translations from English to French; (b) synthesis of the two translations; (c) back-translations; (d) comparisons between the back-translations and the original questionnaire by an expert committee; (e) pretest; and (f) approval of the final French version of the Functional Assessment Scale for Hamstring Injury questionnaire. To validate this French version, 116 subjects (17 pathological patients, 19 patients with other muscle injury, 40 athletes at risk, and 40 healthy control athletes) were recruited to complete the Functional Assessment Scale for Hamstring Injury questionnaire. The Short Form Health Survey (SF-36) was used as a comparative questionnaire. The psychometric properties of the questionnaire were evaluated by determining the test-retest reliability after a 48–60-h interval, internal consistency, construct validity, and floor/ceiling effects. Results: All of the items of the Functional Assessment Scale for Hamstring Injury questionnaire were translated without any major difficulties. The questionnaire showed excellent discriminative power by obtaining significantly different scores from the four groups (p¼0.01). Regarding psychometric performances, the test–retest reliability was excellent (IntraClass Coefficient Correlation of 0.997). Very high internal consistency was also observed (Cronbach’s alpha of 0.969). Correlations with the physical health subscales of the SF-36 were significant and considered to be strong, indicating an excellent convergent validity. The other subscales of the SF-36 (mental health) were weakly correlated with the FASH, reflecting good divergent validity. No floor or ceiling effects were observed. Conclusion: The French-translation of the Functional Assessment Scale for Hamstring Injury questionnaire and its cross-cultural adaptation can be considered to be successful. Functional Assessment Scale for Hamstring Injury-French questionnaire is now a reliable and valid tool for patients suffering from acute hamstring injury, and its application in clinical practice is particularly relevant. IMPLICATIONS FOR REHABILITATION The FASH-F can be considered to be discriminant, reliable and valid for the evaluation of the severity of symptoms and sports ability in individuals with hamstring injuries. FASH-F is now a reliable and valid tool for French-speaking patients suffering from acute hamstring injury, and its application in clinical practice is particularly relevant. A limitation of our study could be that the distribution between the different study groups was not homogeneous implying that our findings may not be fully representative of the general population. [less ▲]

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See detailAlternative and complementary therapies in osteoarthritis and cartilage repair
Fuggle, Nicholas R; Cooper, Cyrus; Oreffo, Richard O.C. et al

in Aging Clinical and Experimental Research (2020), 32(4), 547-560

Osteoarthritis (OA) is the most common joint condition and, with a burgeoning ageing population, is due to increase in prevalence. Beyond conventional medical and surgical interventions, there are an ... [more ▼]

Osteoarthritis (OA) is the most common joint condition and, with a burgeoning ageing population, is due to increase in prevalence. Beyond conventional medical and surgical interventions, there are an increasing number of ‘alternative’ therapies. These alternative therapies may have a limited evidence base and, for this reason, are often only afforded brief reference (or completely excluded) from current OA guidelines. Thus, the aim of this review was to synthesize the current evidence regarding autologous chondrocyte implantation (ACI), mesenchymal stem cell (MSC) therapy, platelet-rich plasma (PRP), vitamin D and other alternative therapies. The majority of studies were in knee OA or chondral defects. Matrix-assisted ACI has demonstrated exceedingly limited, symptomatic improvements in the treatment of cartilage defects of the knee and is not supported for the treatment of knee OA. There is some evidence to suggest symptomatic improvement with MSC injection in knee OA, with the suggestion of minimal structural improvement demonstrated on MRI and there are positive signals that PRP may also lead to symptomatic improvement, though variation in preparation makes inter-study comparison difficult. There is variability in findings with vitamin D supplementation in OA, and the only recommendation which can be made, at this time, is for replacement when vitamin D is deplete. Other alternative therapies reviewed have some evidence (though from small, poor-quality studies) to support improvement in symptoms and again there is often a wide variation in dosage and regimens. For all these therapeutic modalities, although controlled studies have been undertaken to evaluate effectiveness in OA, these have often been of small size, limited statistical power, uncertain blindness and using various methodologies. These deficiencies must leave the question as to whether they have been validated as effective therapies in OA (or chondral defects). The conclusions of this review are that all alternative interventions definitely require clinical trials with robust methodology, to assess their efficacy and safety in the treatment of OA beyond contextual and placebo effects. [less ▲]

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See detailCorrection to: Impact of whole dairy matrix on musculoskeletal health and aging–current knowledge and research gaps (Osteoporosis International, (2019), 10.1007/s00198-019-05229-7)
Geiker, N. R. W.; Mølgaard, C.; Iuliano, S. et al

in Osteoporosis International (2020), 31(4), 795

The article “Impact of whole dairy matrix on musculoskeletal health and aging–current knowledge and research gaps” written by N.R.W. Geiker, C. Mølgaard, S. Iuliano, R. Rizzoli,Y. Manios, L.J.C. van Loon ... [more ▼]

The article “Impact of whole dairy matrix on musculoskeletal health and aging–current knowledge and research gaps” written by N.R.W. Geiker, C. Mølgaard, S. Iuliano, R. Rizzoli,Y. Manios, L.J.C. van Loon, J.-M. Lecerf, G. Moschonis, J.-Y. Reginster, I. Givens, and A. Astrup was originally published electronically on 14 November 2019 without open access. With the author(s)’ decision to opt for Open Choice, the copyright of the article changed on January 2020 to © The Author(s) 2019 and the article is forthwith distributed under the terms of a Creative Commons Attribution-NonCommercial 4.0 International License (https://creativecommons.org/licenses/bync/ 4.0/), which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in anymediumor format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. Ifmaterial is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creativecommons.org/licenses/by-nc/4.0/. © 2020, The Author(s). [less ▲]

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See detailThe Value of a Patient-Level Modeling Approach and Need for Better Reporting in Economic Evaluations of Osteoporosis
Hiligsmann, Mickael; Reginster, Jean-Yves ULiege; Silverman, Stuart

in Journal of Managed Care and Specialty Pharmacy (2020), 26(3), 334-335

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See detailTotal joint replacement improves pain, functional quality of life, and health utilities in patients with late-stage knee and hip osteoarthritis for up to 5 years
Neuprez, Audrey ULiege; Neuprez, Arnaud ULiege; KAUX, Jean-François ULiege et al

in Clinical Rheumatology (2020), 39(3), 861-871

Objectives: To study and identify the determinants of the impact on pain, function, and quality of life of a prosthetic replacement surgery after 5 years of survival in patients with osteoarthritis (OA ... [more ▼]

Objectives: To study and identify the determinants of the impact on pain, function, and quality of life of a prosthetic replacement surgery after 5 years of survival in patients with osteoarthritis (OA) of the lower limb. Method: In total, 626 osteoarthritic patients from a University Hospital, divided in 2 groups (according to surgical site), were prospectively followed for 5 years after hip (n = 346) or knee (n = 280) replacement. Validated specific Western Ontario and McMaster Universities Arthritis Index (WOMAC) and generic (SF-36 and EQ) instruments assessing quality of life were used prior to surgery and yearly, thereafter. We defined a good outcome as a clinically relevant improvement in WOMAC greater than or equal to the minimally important difference (MID). Régressions showed the relationships among preoperative, perioperative, and postoperative measures and the evolution of WOMAC scores after 5 years (percent change). We also examined any predictors of good outcomes. Results: The beneficial effect on quality of life observed during the first year after hip and knee arthroplasty (HA and KA) was maintained for up to 5 years. More than 3/4 of the patients in our study experienced a good outcome (86.04% in HA group and 79.91% inKA group). Both the good outcome and the 5-year change inWOMAC are predicted by preoperative (i.e., radiological severity, comorbidities, disability, and level of education), perioperative (i.e., length of hospital stay and place of discharge), and postoperative (i.e., complications) variables in the two groups. Conclusions: Joint arthroplasty is a highly valuable therapeutic strategy for hip or knee OA patients who do not respond to pharmacological management. These results represent a step towards the collection of robust, scientifically sound data that will facilitate the completion of health economic analyses in the field of OA. [less ▲]

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See detailInfluence of bone mineral density in circulating adipokines among postmenopausal Arab women
Ansari, Mohammed Ghouse Ahmed; Hussain, Syed Danish; Wani, Kaiser Ahmed et al

in Saudi Journal of Biological Sciences (2020), 27(1), 374-379

Osteoporosis and osteopenia has a significant link with substantial fracture risk. Epidemiological data revealed a protective role of adipose tissue on bone biology in postmenopausal osteoporosis. The ... [more ▼]

Osteoporosis and osteopenia has a significant link with substantial fracture risk. Epidemiological data revealed a protective role of adipose tissue on bone biology in postmenopausal osteoporosis. The current study assessed the associations between select adipokines and bone mineral density (BMD) in postmenopausal women. A total of 175 Saudi postmenopausal women were selected and categorized based on their BMD (normal & low-BMD). Circulating levels of select adipokines (adiponectin, resistin, leptin, and adipsin), insulin, 25(OH)D and RANKl were determined using commercially available assay kits. BMD was measured by dual-energy X-ray absorptiometry (DXA). Overall and among low-BMD subjects, adiponectin consistently showed a significant inverse association with BMD (overall -0.34, p < 0.01; low BMD group -0.34, p < 0.01). In multiple regression, adiponectin (-0.29 ± 0.06, p < 0.00) and resistin (-0.08 ± 0.04, p < 0.05) were inversely significant with BMD overall, but after stratification the significance was lost for resistin (-0.05 ± 0.04, p < 0.224) whereas adiponectin remained (-0.22 ± 0.07, p < 0.02) in low-BMD subjects. Adipsin, leptin and lipocalin-2 showed no significant associations. Findings of the present study revealed that only adiponectin showed a significantly strong inverse association with low BMD, suggesting that insulin sensitivity may influence bone health in Arab postmenopausal women. [less ▲]

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See detailA single dose of zoledronate preserves bone mineral density for up to 2 years after a second course of romosozumab
McClung, M.R.; Bolognese, M.A.; Brown, J.P. et al

in Osteoporosis International (2020), 31(11), 2231-2241

Summary: This phase 2 study evaluated the efficacy and safety of transitioning to zoledronate following romosozumab treatment in postmenopausal women with low bone mass. A single dose of 5 mg zoledronate ... [more ▼]

Summary: This phase 2 study evaluated the efficacy and safety of transitioning to zoledronate following romosozumab treatment in postmenopausal women with low bone mass. A single dose of 5 mg zoledronate generally maintained the robust BMD gains accrued with romosozumab treatment and was well tolerated. Introduction: Follow-on therapy with an antiresorptive agent is necessary to maintain the skeletal benefits of romosozumab therapy. We evaluated the use of zoledronate following romosozumab treatment. Methods: This phase 2, dose-finding study enrolled postmenopausal women with low bone mineral density (BMD). Subjects who received various romosozumab doses or placebo from months 0–24 were rerandomized to denosumab (60 mg SC Q6M) or placebo for 12 months, followed by open-label romosozumab (210 mg QM) for 12 months. At month 48, subjects who had received active treatment for 48 months were assigned to no further active treatment and all other subjects were assigned to zoledronate 5 mg IV. Efficacy (BMD, P1NP, and β-CTX) and safety were evaluated for 24 months, up to month 72. Results: A total of 141 subjects entered the month 48–72 period, with 51 in the no further active treatment group and 90 in the zoledronate group. In subjects receiving no further active treatment, lumbar spine (LS) BMD decreased by 10.8% from months 48–72 but remained 4.2% above the original baseline. In subjects receiving zoledronate, LS BMD was maintained (percentage changes: − 0.8% from months 48–72; 12.8% from months 0–72). Similar patterns were observed for proximal femur BMD in both groups.With no further active treatment, P1NP and β-CTX decreased but remained above baseline at month 72. Following zoledronate, P1NP and β-CTX levels initially decreased but approached baseline by month 72. No new safety signals were observed. Conclusion: A zoledronate follow-on regimen can maintain robust BMD gains achieved with romosozumab treatment. [less ▲]

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See detailInterventions to improve adherence to anti-osteoporosis medications: an updted systematic review
Cornelissen, D.; de Kunder, S.; Si, L. et al

in Osteoporosis International (2020), 31(9), 1645-1669

Summary: An earlier systematic review on interventions to improve adherence and persistence was updated. Fifteen studies investigating the effectiveness of patient education, drug regimen, monitoring and ... [more ▼]

Summary: An earlier systematic review on interventions to improve adherence and persistence was updated. Fifteen studies investigating the effectiveness of patient education, drug regimen, monitoring and supervision, and interdisciplinary collaboration as a single or multi-component intervention were appraised. Multicomponent interventions with active patient involvement were more effective. Introduction: This study was conducted to update a systematic literature review on interventions to improve adherence to antiosteoporosis medications. Methods: A systematic literature review was carried out in Medline (using PubMed), Embase (using Ovid), Cochrane Library, Current Controlled Trials, ClinicalTrials.gov, NHS Centre for Review and Dissemination, CINHAL, and PsycINFO to search for original studies that assessed interventions to improve adherence (comprising initiation, implementation, and discontinuation) and persistence to anti-osteoporosis medications among patients with osteoporosis, published between July 2012 and December 2018. Quality of included studies was assessed. Results: Of 585 studies initially identified, 15 studies fulfilled the inclusion criteria of which 12 were randomized controlled trials. Interventions were classified as (1) patient education (n = 9), (2) drug regimen (n = 3), (3)monitoring and supervision (n = 2), and (4) interdisciplinary collaboration (n = 1). In most subtypes of interventions, mixed results on adherence (and persistence) were found. Multicomponent interventions based on patient education and counseling were the most effective interventions when aiming to increase adherence and/or persistence to osteoporosis medications. Conclusion: This updated review suggests that patient education, monitoring and supervision, change in drug regimen, and interdisciplinary collaboration have mixed results on medication adherence and persistence, with more positive effects for multicomponent interventions with active patient involvement. Compared with the previous review, a shift towards more patient involvement, counseling and shared decision-making, was seen, suggesting that individualized solutions, based on collaboration between the patient and the healthcare provider, are needed to improve adherence and persistence to osteoporosis medications. [less ▲]

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