The role and impact of health economics in the optimization of patient care in osteoarthritis: insights from a practical example.

Osteoarthritis (OA) is a degenerative joint disease with a substantial global burden, causing chronic pain and reduced quality of life. Managing OA efficiently while maximizing healthcare resources is crucial. Health economics and health technology assessment (HTA) are central tools providing a framework to evaluate the clinical, economic, and ethical aspects of healthcare technologies and interventions. This article presents some insights into the role of health economics and the HTA process in OA management. It also illustrates an example of cost-effectiveness analysis in a specific healthcare context, on the basis of a recent clinical trial involving hyaluronic acid treatment for knee OA. While HTA offers valuable insights, it faces challenges like data availability and resource constraints. Integrating health economics into decision-making can enhance patient care and allocate resources effectively in OA and other healthcare domains.

Does health literacy mediate the relationship between socioeconomic status and health related outcomes in the Belgian adult population?

BACKGROUND: Health literacy (HL) has been put forward as a potential mediator through which socioeconomic status (SES) affects health. This study explores whether HL mediates the relation between SES and a selection of health or health-related outcomes. METHODS: Data from the participants of the Belgian health interview survey 2018 aged 18 years or older were individually linked with data from the Belgian compulsory health insurance (n = 8080). HL was assessed with the HLS-EU-Q6. Mediation analyses were performed with health behaviour (physical activity, diet, alcohol and tobacco consumption), health status (perceived health status, mental health status), use of medicine (purchase of antibiotics), and use of preventive care (preventive dental care, influenza vaccination, breast cancer screening) as dependent outcome variables, educational attainment and income as independent variables of interest, age and sex as potential confounders and HL as mediating variable. RESULTS: The study showed that unhealthy behaviours (except alcohol consumption), poorer health status, higher use of medicine and lower use of preventive care (except flu vaccination) were associated with low SES (i.e., low education and low income) and with insufficient HL. HL partially mediated the relationship between education and health behaviour, perceived health status and mental health status, accounting for 3.8-16.0% of the total effect. HL also constituted a pathway by which income influences health behaviour, perceived health status, mental health status and preventive dental care, with the mediation effects accounting for 2.1-10.8% of the total effect. CONCLUSIONS: Although the influence of HL in the pathway is limited, our findings suggest that strategies for improving various health-related outcomes among low SES groups should include initiatives to enhance HL in these population groups. Further research is needed to confirm our results and to better explore the mediating effects of HL.

Evidence-Based Guideline for the management of osteoporosis in men.

Historically, osteoporosis has been viewed as a disease of women, with research, trials of interventions and guidelines predominantly focused as such. It is apparent, however, that this condition causes a substantial health burden in men also, and that its assessment and management must ultimately be addressed across both sexes. In this article, an international multidisciplinary working group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases presents GRADE-assessed recommendations for the diagnosis, monitoring and treatment of osteoporosis in men. The recommendations are based on a comprehensive review of the latest research related to diagnostic and screening approaches for osteoporosis and its associated high fracture risk in men, covering disease burden, appropriate interpretation of bone densitometry (including the use of a female reference database for densitometric diagnosis in men) and absolute fracture risk, thresholds for treatment, and interventions that can be used therapeutically and their health economic evaluation. Future work should specifically address the efficacy of anti-osteoporosis medications, including denosumab and bone-forming therapies.

Assessment of risk factors associated with long-term mortality in nursing homes: result from the SENIOR cohort.

BACKGROUND: Previous studies on risk factors for death in nursing homes have focused on short-term observation and limited number risk factors. AIMS: This study aims to identify factors predictive of 8-year survival in nursing homes. METHODS: The study used the baseline measurements from the SENIOR cohort collected in 2013-2014. Data included clinical assessments (i.e., body composition, nutritional status, physical performance, level of dependence and cognition, frailty phenotype) as well as demographic information, number of medications and medical history. Mortality data were collected annually for 8 years. Univariate analyses were initially performed to assess potential predictive factors, followed by a Cox regression model using stepwise selection. RESULTS: Of the 662 participants enrolled in the cohort, 58 (8.8%) were not further assessed due to the withdrawal of 2 nursing homes and 71 (10.7%) had no mortality data available (i.e., relocation, refusal to continue the study). Among the 533 patients included, 111 (20.8%) were still alive in 2022. Median survival time was 4 years (1.93-6.94). Multivariate regression showed that younger age (HR = 1.04 (1.03-1.06)), higher body mass index (HR = 0.96 (0.94-0.98)), higher score on the Mini-Mental State-Examination (HR = 0.97 (0.94-0.99)) and higher score on the Short Physical Performance Battery (HR = 0.93 (0.90-0.97)) were protective factors against mortality. CONCLUSIONS: This study highlights that certain modifiable factors related to physical or mental health contribute to increased survival in nursing homes. Because of its ability to improve physical performance and partly cognitive function, promoting physical activity in nursing homes appears to be a public health priority.

Real-world evidence: new opportunities for osteoporosis research. Recommendations from a Working Group from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

This narrative review summarises the recommendations of a Working Group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) for the conduct and reporting of real-world evidence studies with a focus on osteoporosis research. PURPOSE: Vast amounts of data are routinely generated at every healthcare contact and activity, and there is increasing recognition that these real-world data can be analysed to generate scientific evidence. Real-world evidence (RWE) is increasingly used to delineate the natural history of disease, assess real-life drug effectiveness, understand adverse events and in health economic analysis. The aim of this work was to understand the benefits and limitations of this type of data and outline approaches to ensure that transparent and high-quality evidence is generated. METHODS: A ESCEO Working Group was convened in December 2022 to discuss the applicability of RWE to osteoporosis research and approaches to best practice. RESULTS: This narrative review summarises the agreed recommendations for the conduct and reporting of RWE studies with a focus on osteoporosis research. CONCLUSIONS: It is imperative that research using real-world data is conducted to the highest standards with close attention to limitations and biases of these data, and with transparency at all stages of study design, data acquisition and curation, analysis and reporting to increase the trustworthiness of RWE study findings.

Health Technology Assessment of Different Glucosamine Formulations and Preparations Currently Marketed in Thailand.

OBJECTIVE: The aim of this study was to evaluate the cost-effectiveness of different glucosamine formulations and preparations used for the management of osteoarthritis in Thailand compared with placebo. METHODS: We used a validated model to simulate the individual patient Utility score from aggregated data available from 10 different clinical trials. We then used the Utility score to calculate the quality-adjusted life year (QALY) over 3 and 6 months treatment period. We used the public costs of glucosamine products available in Thailand in 2019 to calculate the incremental cost-effectiveness ratio. We separated the analyses for prescription-grade crystalline glucosamine sulfate (pCGS) and other formulations of glucosamine. A cost-effectiveness cut-off of 3.260 USD/QALY was considered. RESULTS: Irrespective of the glucosamine preparation (tablet or powder/capsule), the data show that pCGS is cost-effective compared with placebo over a 3 and 6 months. However, the other glucosamine formulations (e.g., glucosamine hydrochloride) never reached the breakeven point at any time. CONCLUSIONS: Our data show that pCGS is cost-effective for the management of osteoarthritis in the Thai context while other glucosamine formulations are not.

Biochemical Markers of Musculoskeletal Health and Aging to be Assessed in Clinical Trials of Drugs Aiming at the Treatment of Sarcopenia: Consensus Paper from an Expert Group Meeting Organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the Centre Académique de Recherche et d'Expérimentation en Santé (CARES SPRL), Under the Auspices of the World Health Organization Collaborating Center for the Epidemiology of Musculoskeletal Conditions and Aging.

In clinical trials, biochemical markers provide useful information on the drug's mode of action, therapeutic response and side effect monitoring and can act as surrogate endpoints. In pharmacological intervention development for sarcopenia management, there is an urgent need to identify biomarkers to measure in clinical trials and that could be used in the future in clinical practice. The objective of the current consensus paper is to provide a clear list of biochemical markers of musculoskeletal health and aging that can be recommended to be measured in Phase II and Phase III clinical trials evaluating new chemical entities for sarcopenia treatment. A working group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) proposed classifying biochemical markers into 2 series: biochemical markers evaluating musculoskeletal status and biochemical markers evaluating causal factors. For series 1, the group agreed on 4 biochemical markers that should be assessed in Phase II or Phase III trials (i.e., Myostatin-Follistatin, Brain Derived Neurotrophic Factor, N-terminal Type III Procollagen and Serum Creatinine to Serum Cystatin C Ratio - or the Sarcopenia Index). For series 2, the group agreed on 6 biochemical markers that should be assessed in Phase II trials (i.e., the hormones insulin-like growth factor-1 (IGF-I), dehydroepiandrosterone sulphate, and cortisol, and the inflammatory markers C-reactive protein (CRP), interleukin-6 and tumor necrosis factor-α), and 2 in Phase III trials (i.e., IGF-I and CRP). The group also proposed optional biochemical markers that may provide insights into the mode of action of pharmacological therapies. Further research and development of new methods for biochemical marker assays may lead to the evolution of these recommendations.

Role of vitamin D supplementation in the management of musculoskeletal diseases: update from an European Society of Clinical and Economical Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) working group.

Vitamin D is a key component for optimal growth and for calcium-phosphate homeostasis. Skin photosynthesis is the main source of vitamin D. Limited sun exposure and insufficient dietary vitamin D supply justify vitamin D supplementation in certain age groups. In older adults, recommended doses for vitamin D supplementation vary between 200 and 2000 IU/day, to achieve a goal of circulating 25-hydroxyvitamin D (calcifediol) of at least 50 nmol/L. The target level depends on the population being supplemented, the assessed system, and the outcome. Several recent large randomized trials with oral vitamin D regimens varying between 2000 and 100,000 IU/month and mostly conducted in vitamin D-replete and healthy individuals have failed to detect any efficacy of these approaches for the prevention of fracture and falls. Considering the well-recognized major musculoskeletal disorders associated with severe vitamin D deficiency and taking into account a possible biphasic effects of vitamin D on fracture and fall risks, an European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) working group convened, carefully reviewed, and analyzed the meta-analyses of randomized controlled trials on the effects of vitamin D on fracture risk, falls or osteoarthritis, and came to the conclusion that 1000 IU daily should be recommended in patients at increased risk of vitamin D deficiency. The group also addressed the identification of patients possibly benefitting from a vitamin D loading dose to achieve early 25-hydroxyvitamin D therapeutic level or from calcifediol administration.

Health Economic Evaluation of a High and Low Molecular Weight Hyaluronic Acid Formulation for the Treatment of Knee Osteoarthritis. Post Hoc Analyses from a Randomized Clinical Trial.

INTRODUCTION: In a recent randomized placebo-controlled trial, a single intra-articular injection of a high and low molecular weight hyaluronic acid formulation (HA-HL) was shown to be effective in providing a clinically meaningful reduction in pain and functional limitation up to 24 weeks in subjects with painful knee osteoarthritis (OA). The objective of this post hoc analyses is to assess the cost-effectiveness of HA-HL compared with placebo using individual patient data from this clinical trial in a Swiss health care perspective. METHODS: A total of 692 patients fulfilling the inclusion criteria were randomly allocated to HA-HL or placebo groups. Each patient received one intra-articular injection of HA-HL or placebo at baseline and was then followed-up for a total duration of 24 weeks with five follow-up visits (i.e., after weeks 1, 6, 12, 18, and 24). The EQ-5D-5L five-point verbal Likert scale was used to calculate the health utility and the related quality-adjusted life-years (QALYs) using the area-under-the-curve (AUC) method. For the costs, the price of HA-HL in Switzerland was used. The primary threshold for the incremental cost/effectiveness ratio (ICER) below which HA-HL was considered as cost-effective was 91,540 Swiss francs (CHF) per QALY (i.e., US $100,000). RESULTS: No significant difference between the baseline characteristics of the HA-HL group and the placebo group was observed. With a mean ICER of 27,212 CHF per QALY (95% CI 20,135-34,289), HA-HL was considered as cost-effective compared to placebo. Sensitivity analyses (e.g., using lower or upper limit prices or using other threshold values) gave similar results, i.e., ICERs far below the threshold values of cost-effectiveness. CONCLUSIONS: These results confirm the role of HA-HL as a cost-effective therapeutic option in the management of OA. However, more studies taking into account the utilization of other health care resources are needed.

Assessment of the Response Profile to Hyaluronic Acid Plus Sorbitol Injection in Patients with Knee Osteoarthritis: Post-Hoc Analysis of a 6-Month Randomized Controlled Trial.

In a previous randomized trial, the non-inferiority of two hyaluronic acid injections (Synolis VA versus Synvisc-One) was assessed in patients with knee OA, with a response rate of 79% for Synolis VA. To assess whether a responder profile could be established for this treatment modality, we used the Synolis VA arm of a published 6-month prospective, multicenter, comparative, randomized, double-blinded trial. At baseline and during the study, pain and function were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire. Ninety-six subjects from the intention-to-treat trial were included in the analysis. The 6-month change of WOMAC Pain with Synolis VA was not associated with any baseline clinical data. However, the change in WOMAC Function was significantly associated with its baseline level, even after adjustment for potential confounding variables (p = 0.028), i.e., a poorer physical function at baseline was associated with a better response. In conclusion, in addition to the high absolute response rate to Synolis VA, the probability of success is even increased if administered in patients with more limited physical function at baseline. Further research with other potential confounding clinical variables is warranted in order to better applicate the concept of personalized medicine.

Assessment of the performance of the SarQoL® questionnaire in screening for sarcopenia in older people.

BACKGROUND: Because of its low prevalence and the need for physical tests to establish a diagnosis, recruiting sarcopenic people for clinical studies can be a resource-intensive process. AIMS: We investigated whether the SarQoL®, a 55-item questionnaire designed to measure quality of life in sarcopenia, could be used to identify older people with a high likelihood of being sarcopenic, and to compare its performance to the SARC-F tool. METHODS: We performed a secondary analysis of data from older, community-dwelling participants of the SarcoPhAge study, evaluated for sarcopenia according to the EWGSOP2 criteria, and who completed the SarQoL® and SARC-F questionnaires. We determined the optimal threshold to distinguish between sarcopenic and non-sarcopenic people with the Youden index. Screening performance was evaluated with the area under the curve (AUC) and by calculating sensitivity and specificity. RESULTS: The analysis of 309 participants provided an optimal threshold value of ≤ 52.4 points for identifying people with sarcopenia with the SarQoL® questionnaire, which resulted in a sensitivity of 64.7% (41.1-84.2%), a specificity of 80.5% (75.7-84.7%) and an AUC of 0.771 (0.652-0.889). Compared to the SARC-F, the SarQoL® has greater sensitivity (64.7% vs 52.39%), but slightly lower specificity (80.5% vs. 86.6%). DISCUSSION: The SarQoL® questionnaire showed acceptable screening accuracy, on par with the SARC-F. The optimal threshold of ≤ 52.4 points should be confirmed in other cohorts of older people. CONCLUSIONS: This exploratory study showed that the SarQoL® could potentially be applied in a screening strategy, with the added benefit of providing a measure of QoL at the same time.

Malnutrition, assessed by the Global Leadership Initiative on Malnutrition (GLIM) criteria but not by the mini nutritional assessment (MNA), predicts the incidence of sarcopenia over a 5-year in the SarcoPhAge cohort.

BACKGROUND: The capacity of malnutrition screening to predict the onset of sarcopenia is unknown. AIM: Our first objective is to explore the association between the screening of malnutrition and the incidence of sarcopenia and then, to assess the added value of the diagnosis of malnutrition to predict sarcopenia over a 5-year follow-up. METHODS: Malnutrition was screened at baseline according to the MNA short-form (MNA-SF) and long-form (MNA-LF) and was diagnosed by the GLIM definition. Sarcopenia was defined using the European Working Group on Sarcopenia in Older People (EWGSOP2) criteria. Kaplan-Meier analysis and adjusted Cox regression were performed to explore the association between nutritional status and the incidence of sarcopenia. RESULTS: A total of 418 participants were analyzed (median age 71.7 years (67.7 - 76.8), 60% women) for our first objective. Among them, 64 (15.3%) became sarcopenic during the follow-up period. In the adjusted model, the incidence of sarcopenia was nonsignificantly associated with the risk of malnutrition for both forms of the MNA (MNA-SF: HR of 1.68 (95% CI 0.95 - 2.99); MNA-LF: HR of 1.67 (95% CI 0.86 - 3.26)). However, among the 337 participants for which a GLIM assessment was possible and in which 46 participants became sarcopenic, malnourished subjects had a higher risk than well-nourished participants of developing sarcopenia after 5 years, with an adjusted HR of 3.19 (95% CI 1.56 - 6.50). CONCLUSION: A full diagnosis of malnutrition seems more useful than a simple malnutrition screening to predict the incidence of sarcopenia over 5 years.

Cost-Effectiveness Assessment of Different Glucosamines in Patients with Knee Osteoarthritis: A Simulation Model Adapted to Germany.

BACKGROUND: The use of symptomatic slow-acting drugs for osteoarthritis (OA) (e.g., glucosamine, chondroitin) is largely debated in the scientific literature. Indeed, multiple formulations of these agents are available, both as pharmaceutical-grade products and as nutritional supplements , but while all preparations may claim to deliver a therapeutic effect, not all are supported by clinical evidence. Moreover, few data are available regarding the cost-effectiveness of all these formulations. Usually, access to individual patient data is required to perform economic evaluations of treatments, but it can be challenging to obtain. We previously developed a model to simulate individual health utility scores from aggregated data obtained from published OA trials. OBJECTIVE: In the present study, using our new simulation model, we investigated the costeffectiveness of different glucosamines used in Germany. METHODS: We used our validated model to simulate the utility scores of 10 published trials that used different glucosamine preparations. Using the simulated utility scores, the quality-adjusted life years (QALYs) were calculated using the area-under-the-curve method. We used the 2018 public costs of glucosamine products available in Germany to calculate the Incremental Cost/Effectiveness Ratio (ICER). We performed analyses for pharmaceutical-grade Crystalline Glucosamine Sulfate (pCGS) and other formulations of glucosamine (OFG). A cost-effectiveness cut-off of 30,000 €/QALY was considered. RESULTS: Of 10 studies in which utility was simulated, four used pCGS, and six used OFG. The ICER analyses showed that pCGS was cost-effective compared to a placebo, with an ICER of 4489 €/QALY at month 3, 4112 €/QALY at month 6, and 9983 €/QALY at year 3. The use of OFG was not cost-effective at any of the time points considered. CONCLUSION: Using our previously published model to simulate the individual health utility scores of patients, we showed that, in the German context, the use of pCGS could be considered costeffective, while the use of OFG could not. These results highlight the importance of the formulation of glucosamine.

Experts' preferences for sarcopenia outcomes: a discrete-choice experiment from a working group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) in collaboration with the European Union of Geriatric Medicine Society (EUGMS).

BACKGROUND AND AIMS: To assess experts' preference for sarcopenia outcomes. METHODS: A discrete-choice experiment was conducted among 37 experts (medical doctors and researchers) from different countries around the world. In the survey, they were repetitively asked to choose which one of two hypothetical patients suffering from sarcopenia deserves the most a treatment. The two hypothetical patients differed in five pre-selected sarcopenia outcomes: quality of life, mobility, domestic activities, fatigue and falls. A mixed logit panel model was used to estimate the relative importance of each attribute. RESULTS: All sarcopenia outcomes were shown to be significant, and thus, important for experts. Overall, the most important sarcopenia outcome was falls (27%) followed by domestic activities and mobility (24%), quality of life (15%) and fatigue (10%). DISCUSSION AND CONCLUSION: Compared to patient's preferences, experts considered falls as a more important outcome of sarcopenia, while the outcomes fatigue and difficulties in domestic activities were considered as less important.

French Translation and Validation of the Victorian Institute of Sports Assessment for Gluteal Tendinopathy Questionnaire.

BACKGROUND: Developed in 2015, the Victorian Institute for Sport Assessment for Gluteal Tendinopathy (VISA-G) is the first patient-reported outcome measure tool specifically designed to measure the severity of disability associated with greater trochanteric pain syndrome. There is currently no French version of the VISA-G questionnaire. OBJECTIVE: To translate the VISA-G questionnaire into French (VISA-GF) and to test its psychometric performances. DESIGN: Cross-sectional study, validation study. SETTING: Clinics in Liège, Belgium and in France. PATIENTS: Participants with greater trochanteric pain syndrome and control asymptomatic participants. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: French translation of the VISA-G and psychometric performances of the questionnaire tested using internal consistency, construct validity and test-retest reliability with a 7-day interval. RESULTS: The eight items of the VISA-G questionnaire were translated without any difficulties. The psychometric validation study included 106 participants (median age 53 [58-64] years old, 65 women [61.3%]). The questionnaire discriminates well between pathologic (n = 52) and asymptomatic participants (n = 54). Moreover, we found a good internal consistency and excellent test-retest reliability for the VISA-GF questionnaire. We also confirmed the construct validity and did not find any floor or ceiling effects. CONCLUSIONS: The VISA-GF has been shown to be a valid and reliable way to measure the severity of disability associated with greater trochanteric pain syndrome in French-speaking participants.

Cross-cultural adaptation, translation, and validation of the functional assessment scale for acute hamstring injuries (FASH) questionnaire for French-speaking patients.

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 (p = 0.01). 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 rehabilitationThe 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.

Algorithm for the Use of Biochemical Markers of Bone Turnover in the Diagnosis, Assessment and Follow-Up of Treatment for Osteoporosis.

INTRODUCTION: Increased biochemical bone turnover markers (BTMs) measured in serum are associated with bone loss, increased fracture risk and poor treatment adherence, but their role in clinical practice is presently unclear. The aim of this consensus group report is to provide guidance to clinicians on how to use BTMs in patient evaluation in postmenopausal osteoporosis, in fracture risk prediction and in the monitoring of treatment efficacy and adherence to osteoporosis medication. METHODS: A working group with clinical scientists and osteoporosis specialists was invited by the Scientific Advisory Board of European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). RESULTS: Serum bone formation marker PINP and resorption marker ßCTX-I are the preferred markers for evaluating bone turnover in the clinical setting due to their specificity to bone, performance in clinical studies, wide use and relatively low analytical variability. BTMs cannot be used to diagnose osteoporosis because of low sensitivity and specificity, but can be of value in patient evaluation where high values may indicate the need to investigate some causes of secondary osteoporosis. Assessing serum levels of ßCTX-I and PINP can improve fracture prediction slightly, with a gradient of risk of about 1.2 per SD increase in the bone marker in addition to clinical risk factors and bone mineral density. For an individual patient, BTMs are not useful in projecting bone loss or treatment efficacy, but it is recommended that serum PINP and ßCTX-I be used to monitor adherence to oral bisphosphonate treatment. Suppression of the BTMs greater than the least significant change or to levels in the lower half of the reference interval in young and healthy premenopausal women is closely related to treatment adherence. CONCLUSION: In conclusion, the currently available evidence indicates that the principal clinical utility of BTMs is for monitoring oral bisphosphonate therapy.

Radiofrequency echographic multi-spectrometry for the in-vivo assessment of bone strength: state of the art-outcomes of an expert consensus meeting organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

PURPOSE: The purpose of this paper was to review the available approaches for bone strength assessment, osteoporosis diagnosis and fracture risk prediction, and to provide insights into radiofrequency echographic multi spectrometry (REMS), a non-ionizing axial skeleton technique. METHODS: A working group convened by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis met to review the current image-based methods for bone strength assessment and fracture risk estimation, and to discuss the clinical perspectives of REMS. RESULTS: Areal bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) is the consolidated indicator for osteoporosis diagnosis and fracture risk assessment. A more reliable fracture risk estimation would actually require an improved assessment of bone strength, integrating also bone quality information. Several different approaches have been proposed, including additional DXA-based parameters, quantitative computed tomography, and quantitative ultrasound. Although each of them showed a somewhat improved clinical performance, none satisfied all the requirements for a widespread routine employment, which was typically hindered by unclear clinical usefulness, radiation doses, limited accessibility, or inapplicability to spine and hip, therefore leaving several clinical needs still unmet. REMS is a clinically available technology for osteoporosis diagnosis and fracture risk assessment through the estimation of BMD on the axial skeleton reference sites. Its automatic processing of unfiltered ultrasound signals provides accurate BMD values in view of fracture risk assessment. CONCLUSIONS: New approaches for improved bone strength and fracture risk estimations are needed for a better management of osteoporotic patients. In this context, REMS represents a valuable approach for osteoporosis diagnosis and fracture risk prediction.