Perspectives on Fracture Liaison Service in Austria: clinical and economic considerations.

Osteoporosis is a widespread disease and affects over 500,000 people in Austria. Fragility fractures are associated with it and represent not only an individual problem for the patients, but also an enormous burden for the healthcare system. While trauma surgery care is well provided in Vienna, there is an enormous treatment gap in secondary prevention after osteoporotic fracture. Systematic approaches such as the Fracture Liaison Service (FLS) aim to identify patients with osteoporosis after fracture, to clarify diagnostically, to initiate specific therapy, and to check therapy adherence. The aim of this article is to describe the practical implementation and operational flow of an already established FLS in Vienna. This includes the identification of potential FLS inpatients, the diagnostic workup, and recommendations for an IT solution for baseline assessment and follow-up of FLS patients. We summarize the concept, benefits, and limitations of FLS and provide prospective as well as clinical and economic considerations for a city-wide FLS, managed from a central location. Future concepts of FLS should include artificial intelligence for vertebral fracture detection and simple IT tools for the implementation of FLS in the outpatient sector.

Societal costs before and up to 1 year after the first fracture liaison service visit in patients requiring anti-osteoporosis treatments.

This study aimed to estimate societal and healthcare costs incurred before and 1 year after the first fracture liaison services (FLS) visit and to explore differences in fracture type. All costs after 1 year significantly decreased compared to costs preceding the first visit. Fracture type did not significantly affect costs. INTRODUCTION: Limited literature is available on resource utilization and costs of patients visiting fracture liaison services (FLS). This study aimed to estimate the societal and healthcare costs incurred by patients with a recent fracture requiring anti-osteoporosis medication before and 1 year after the first FLS visit and to explore differences according to fracture type. METHODS: Resource utilization was collected through a self-reported questionnaire with a 4-month recall on health resource utilization and productivity losses immediately following the first FLS visit, and 4 and 12 months later. Unit costs derived from the national Dutch guideline for economic evaluations were used to compute societal and healthcare costs. Linear mixed-effect models, adjusted for confounders, were used to analyze societal and healthcare costs over time as well as the effect of fracture type on societal and healthcare costs. RESULTS: A total of 126 patients from two Dutch FLS centers were included, of whom 72 sustained a major fracture (hip, vertebral, humerus, or radius). Societal costs in the 4 months prior to the first visit (€2911) were significantly higher compared to societal costs 4 months (€711, p-value = 0.009) and 12 months later (€581, p-value = 0.001). Fracture type did not have a significant effect on total societal or healthcare costs. All costs 12 months after the initial visit were numerically lower for major fractures compared to others. CONCLUSION: Societal and healthcare costs in the year following the first FLS visit significantly decreased compared to those costs preceding the first visit.

Health service and medication costs associated with common mental disorders and subthreshold symptoms in women: Findings from the Geelong Osteoporosis Study in Australia.

OBJECTIVE: This analysis estimated 2013 annual healthcare costs associated with the common mental disorders of mood and anxiety disorders and psychological symptoms within a representative sample of Australian women. METHODS: Data from the 15-year follow-up of women in the Geelong Osteoporosis Study were linked to 12-month Medicare Benefits Schedule and Pharmaceutical Benefits Scheme data. A Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Non-patient edition identified common mental disorders and the General Health Questionnaire 12 assessed psychological symptoms. Participants were categorised into mutually exclusive groups: (1) common mental disorder (past 12 months), (2) subthreshold (no common mental disorder and General Health Questionnaire 12 score ⩾4) or (3) no common mental disorder and General Health Questionnaire 12 score <4. Two-part and hurdle models estimated differences in service use, and adjusted generalised linear models estimated mean differences in costs between groups. RESULTS: Compared to no common mental disorder, women with common mental disorders utilised more Medicare Benefits Schedule services (mean 26.9 vs 20.0, p < 0.001), had higher total Medicare Benefits Schedule cost ($1889 vs $1305, p < 0.01), received more Pharmaceutical Benefits Scheme prescriptions (35.8 vs 20.6, p < 0.001), had higher total Pharmaceutical Benefits Scheme cost ($1226 vs $740, p < 0.05) and had significantly higher annual out-of-pocket costs for Pharmaceutical Benefits Scheme prescriptions ($249 vs $162, p < 0.001). Compared to no common mental disorder, subthreshold women were less likely to use any Medicare Benefits Schedule service (89.6% vs 97.0%, p < 0.01), but more likely to use mental health services (11.4% vs 2.9%, p < 0.01). The subthreshold group received more Pharmaceutical Benefits Scheme prescriptions (mean 43.3 vs 20.6, p < 0.001) and incurred higher total Pharmaceutical Benefits Scheme cost ($1268 vs $740, p < .05) compared to no common mental disorder. CONCLUSIONS: Common mental disorders and subthreshold psychological symptoms place a substantial economic burden on Australian healthcare services and consumers.

Burden of osteoporosis in Vietnam: An analysis of population risk.

PURPOSE: To estimate the proportion of men and women aged 50 years and older who would be classified as "high risk" for fracture and eligible for anti-fracture treatment. METHODS: The study involved 1421 women and 652 men aged 50 years and older, who were recruited from the general population in Ho Chi Minh City, Vietnam. Fracture history was ascertained from each individual. Bone mineral density (BMD) was measured at the lumbar spine and femoral neck by DXA (Hologic Horizon). The diagnosis of osteoporosis was based on the T-scores ≤ -2.50 derived from either femoral neck or lumbar spine BMD. The 10-year risks of major fractureand hip fracture were estimated from FRAX version for Thai population. The criteria for recommended treatment were based on the US National Osteoporosis Foundation (NOF). RESULTS: The average age of women and men was ~60 yr (SD 7.8). Approximately 11% (n = 152) of women and 14% (n = 92) of men had a prior fracture. The prevalence of osteoporosis was 27% (n = 381; 95% CI, 25 to 29%) in women and 13% (n = 87; 95% CI, 11 to 16%) in men. Only 1% (n = 11) of women and 0.1% (n = 1) of men had 10-year risk of major fracture ≥ 20%. However, 23% (n = 327) of women and 9.5% (n = 62) of men had 10-year risk of hip fracture ≥ 3%. Using the NOF recommended criteria, 49% (n = 702; 95% CI, 47 to 52%) of women and 35% (n = 228; 95% CI, 31 to 39%) of men would be eligible for therapy. CONCLUSION: Almost half of women and just over one-third of men aged 50 years and older in Vietnam meet the NOF criteria for osteoporosis treatment. This finding can help develop guidelines for osteoporosis treatment in Vietnam.

Assessing the effects of National Health Insurance reimbursement policy revisions for anti-osteoporotic drugs in Korean women aged 50 or older.

INTRODUCTION: The Korean National Health Insurance revised its reimbursement criteria to expand coverage for anti-osteoporotic drug treatments in 2011 (expanding diagnostic criteria and the coverage period for anti-osteoporotic therapy) and 2015 (including osteoporotic fracture patients regardless of bone mineral density). We examined whether the two revisions contributed to an increase in the prescription rates of anti-osteoporotic drugs in Korea. METHODS: We used the Health Insurance Review and Assessment Service-National Patient Sample data from 2010 through 2016. A segmented regression analysis of interrupted time series was performed to assess changes in the monthly prescription rates of anti-osteoporotic drugs among women aged 50 or older, defined as the proportion of elderly women prescribed with anti-osteoporotic drugs. RESULTS: Both the levels (i.e., abrupt jump or drop) and the trends (i.e., slope) of the prescription rates of anti-osteoporotic drugs in the general population, osteoporotic patients, and osteoporotic fracture patients showed no significant changes after the first revision. However, there was a significant increase in the trends in the general population (ß = 0.0166, p = 0.0173) and in osteoporotic patients (ß = 0.1128, p = 0.0157) after the second revision. Women aged 65 to 79 years were the most significantly increased group in terms of the treatment proportion after the second revision because the trend was significant after the second revision in all three study populations (ß = 0.0300, 0.1212, 0.1392, respectively; p < 0.05). CONCLUSIONS: Although the two revisions expanded reimbursement coverage, only the second revision on reimbursing based on osteoporotic fracture regardless of bone mineral density was associated with increasing the proportion of post-menopausal women being treated with anti-osteoporotic drugs.

Cost-effectiveness of Screening for Osteoporosis in Older Men With a History of Falls.

Importance: Falls and osteoporosis share the potential clinical end point of fractures among older patients. To date, few fall prevention guidelines incorporate screening for osteoporosis to reduce fall-related fractures. Objective: To assess the cost-effectiveness of screening for osteoporosis using dual-energy x-ray absorptiometry (DXA) followed by osteoporosis treatment in older men with a history of falls. Design, Setting, and Participants: In this economic evaluation, a Markov model was developed to simulate the incidence of major osteoporotic fractures in a hypothetical cohort of community-dwelling men aged 65 years who had fallen at least once in the past year. Data sources included literature published from January 1, 1946, to July 31, 2020. The model adopted a societal perspective, a lifetime horizon, a 1-year cycle length, and a discount rate of 3% per year for both health benefits and costs. The analysis was designed and conducted from October 1, 2019, to September 30, 2020. Interventions: Screening with DXA followed by treatment for men diagnosed with osteoporosis compared with usual care. Main Outcomes and Measures: Incremental cost-effectiveness ratio (ICER), measured by cost per quality-adjusted life-year (QALY) gained. Results: Among the hypothetical cohort of men aged 65 years, the screening strategy had an ICER of $33 169/QALY gained and was preferred over usual care at the willingness-to-pay threshold of $100 000/QALY gained. The number needed to screen to prevent 1 hip fracture was 1876; to prevent 1 major osteoporotic fracture, 746. The screening strategy would become more effective and less costly than usual care for men 77 years and older. The ICER for the screening strategy did not substantially change across a wide range of assumptions tested in all other deterministic sensitivity analyses. At a willingness-to-pay threshold of $50 000/QALY gained, screening was cost-effective in 56.0% of simulations; at $100 000/QALY gained, 90.8% of simulations; and at $200 000/QALY gained, 99.6% of simulations. Conclusions and Relevance: These findings suggest that for older men who have fallen at least once in the past year, screening with DXA followed by treatment for those diagnosed with osteoporosis is a cost-effective use of resources. Fall history could be a useful cue to trigger assessment for osteoporosis in men.

Fragility fractures in Europe: burden, management and opportunities.

This report provides an overview and a comparison of the burden and management of fragility fractures in the largest five countries of the European Union plus Sweden (EU6). In 2017, new fragility fractures in the EU6 are estimated at 2.7 million with an associated annual cost of €37.5 billion and a loss of 1.0 million quality-adjusted life years. INTRODUCTION: Osteoporosis is characterized by reduced bone mass and strength, which increases the risk of fragility fractures, which in turn, represent the main consequence of the disease. This report provides an overview and a comparison of the burden and management of fragility fractures in the largest five EU countries and Sweden (designated the EU6). METHODS: A series of metrics describing the burden and management of fragility fractures were defined by a scientific steering committee. A working group performed the data collection and analysis. Data were collected from current literature, available retrospective data and public sources. Different methods were applied (e.g. standard statistics and health economic modelling), where appropriate, to perform the analysis for each metric. RESULTS: Total fragility fractures in the EU6 are estimated to increase from 2.7 million in 2017 to 3.3 million in 2030; a 23% increase. The resulting annual fracture-related costs (€37.5 billion in 2017) are expected to increase by 27%. An estimated 1.0 million quality-adjusted life years (QALYs) were lost in 2017 due to fragility fractures. The current disability-adjusted life years (DALYs) per 1000 individuals age 50 years or more were estimated at 21 years, which is higher than the estimates for stroke or chronic obstructive pulmonary disease. The treatment gap (percentage of eligible individuals not receiving treatment with osteoporosis drugs) in the EU6 is estimated to be 73% for women and 63% for men; an increase of 17% since 2010. If all patients who fracture in the EU6 were enrolled into fracture liaison services, at least 19,000 fractures every year might be avoided. CONCLUSIONS: Fracture-related burden is expected to increase over the coming decades. Given the substantial treatment gap and proven cost-effectiveness of fracture prevention schemes such as fracture liaison services, urgent action is needed to ensure that all individuals at high risk of fragility fracture are appropriately assessed and treated.

Osteoporosis: Economic Burden of Disease in Italy.

BACKGROUND AND OBJECTIVE: Today, osteoporosis is the most common bone disease and an important public health problem in all developed countries. The objective of this study was to estimate the costs associated with the management and treatment of osteoporosis in order to assess the economic burden in Italy for 2017, in terms of direct medical costs and social security costs. METHODS: A cost of illness model was developed to estimate the average cost per year sustained by the NHS (National Health Service) and Social Security System in Italy. A systematic literature review was performed to obtain epidemiological, direct and indirect costs parameters where available. Hospitalisation costs were calculated considering the administrative database of the hospital discharge records for the period 2008-2016. Patients were enrolled in the analysis if they report the subsequent inclusion criteria: age ≥ 45 years and presence of osteoporosis in primary or secondary diagnosis (ICD9-CM 733.0) and/or presence of a major fracture in primary or secondary diagnosis (excluding road accidents) in the following locations: spine (codes ICD9-CM: 805;806), femur (codes ICD9-CM: 820; 821), radius and ulna (codes ICD9-CM: 813.4; 813.5), humerus (codes ICD9-CM: 812.0-812.5), pelvis (code ICD9-CM: 808), tibia and fibula (codes ICD9-CM: 823), ankle (code ICD9: 824) and ribs (codes ICD9-CM: 807.0; 807.1). Costs were estimated considering the diagnosis-related group (DRG) national tariff associated with each hospitalisation. Finally, the administrative databases of the Italian National Social Security Institute (INPS) (2009-2015) were analysed for the estimate the pension and disability costs from the social perspective. RESULTS: The model estimated an average annual economic burden of osteoporosis in Italy of €2.2 billion. Of this cost, approximately 80% (€1.8 billion) was associated with hospitalisations, 16% (€351 million) for pharmacological treatments, 3% (€71 million) for ambulatory visits, and 0.6% (€13 million) for social security costs. The average yearly cost per patient was equal to €8691 (€8591 for hospitalisations). Analysing severe patients, hospitalisation costs increase to €12,336 (+ 44% if compared to non-severe osteoporosis patients). CONCLUSIONS: The analysis showed that osteoporosis represents one of the main health problems in Italy and the ability to maintain patients in a non-severe health state could decrease the economic burden from both NHS and social perspective.

Cost-effectiveness analyses of interventions to improve osteoporosis care in France.

Osteoporosis (OP) is responsible for an important economic burden, but OP care is far from meeting therapeutic guidelines. Some interventions were effective to improve OP management. Our objective was to evaluate the cost-effectiveness of these interventions. Structural interventions and interventions consisting in sending educational material were dominant strategies. PURPOSE: Osteoporosis (OP) causes many osteoporotic fractures worldwide and an important economic burden as a result. OP care is far from meeting treatment guidelines, but in a recent meta-analysis, we showed that some interventions were effective to improve appropriate bone mineral density (BMD) and treatment prescriptions. In the context of limited resources, it is of major importance to measure these interventions' efficiency. Our objective was to evaluate the cost-effectiveness of existing effective intervention types. METHODS: We used a decision tree incorporating Markov models to compare costs and benefits (quality-adjusted life-years or QALYs) between usual care and three intervention types: structural (I), direct educational through conversation (II), and indirect educational by sending material (III). We adopted the collectivity perspective and chose a 30-year time horizon. The model included efficacy of interventions and risk of further fracture or death, depending on BMD T-score results and OP management, obtained from published literature. The model was populated to reflect a French setting. Deterministic and probabilistic sensitivity analyses were conducted. Costs were presented in 2018 euros (€). RESULTS: Interventions type I and III were dominant strategies compared with usual care (cost-saving with a QALY gain). Our results were consistent through sensitivity analyses. CONCLUSION: Our results suggest that structural interventions and indirect interventions to improve OP care (BMD and OP treatment prescription), in women 50 years old with a first fragility fracture, were dominant strategies.

The burden of osteoporosis in Saudi Arabia: a scorecard and economic model.

Objectives: Aging populations are contributing to an increased volume of osteoporotic fractures. The goals of this study were to (1) develop a scorecard on epidemiological burden, policy framework, service provision, and service uptake for osteoporosis in Saudi Arabia and (2) estimate the direct costs of managing osteoporotic fractures in Saudi Arabia.Methods: Osteoporosis data specific to Saudi Arabia were collected through a systematic literature review and surveys with osteoporosis experts. The data were used to build a scorecard, as done previously for the European Union and select Latin American countries. The scorecard applied traffic light colour coding to identify areas of risk in Saudi Arabia's management of osteoporosis. The data were also used to parameterize a burden of illness model. The model estimated the direct medical costs of fractures among adults aged 50-89 years in Saudi Arabia. The model included hospitalization, testing, hip fracture surgery, and drug costs.Results: In Saudi Arabia, the Ministry of Health was aware of impending increases in the number of fractures and had prioritized osteoporosis on the national agenda. Accordingly, reimbursement restrictions for osteoporosis diagnosis and treatment were minimal. However, a national fracture registry and unified system for monitoring care were not in operation. This represents a critical gap in care that will continue to contribute to the underdiagnosis and undertreatment of osteoporosis if not addressed. In total, 174,225 osteoporosis-related fractures were estimated to occur in Saudi Arabia in 2019, with an annual cost of SR2.38 billion ($636 million USD; $1.55 billion PPP). Hospitalization was the primary cost driver.Conclusions: In 2019, Saudi Arabia was expected to incur SR2.38 billion ($636 million USD; $1.55 billion PPP) in costs owing to 174,225 osteoporosis-related fractures. The establishment of a national fracture registry and implementation of fracture liaison services will be paramount to reducing the fracture burden.

The Authors Respond.

DISCLOSURES: Funding for the original study referred to in this letter was received through the PhRMA Foundation Value Assessment Challenge Award. The authors have no conflicts of interest to declare.

Budget impact analysis of osteoporosis medications for primary prevention of fractures in Taiwan.

INTRODUCTION: Taiwan's national health insurance currently only covers the use of osteoporosis drugs for the secondary prevention of fractures and does not provide coverage for primary prevention. The purpose of this study is to develop a model for analyzing the budgetary impact of the use of osteoporosis medications of primary prevention. METHODS: The budget impact model in this study is the "actual medication cost" minus the "medical expenses for all types of fractures that can be avoided by taking osteoporosis medications." We developed six possible insurance payment plans for primary prevention based on the age of the patients and T-scores and performed eleven steps to estimate the budget impact of each payment plan. RESULTS: The results of this study indicated that there may be 71,220 (T-score ≤ - 3.0, 75 + y/o) to 157,515 (T-score ≤ - 2.5, 65 + y/o) people using the drugs, and the budget impact may be US$26.28-58.98 million in 2019. However, the payment plans may avoid 492-766 fracture events and save medical expenditures for fracture treatment by US$1.30-2.02 million. The average costs for primary prevention within a year will be US$53,386-77,006. CONCLUSION: The budget impact of using osteoporosis medications to primary prevention of fractures is significant, but it can be compensated due to savings in fracture treatment costs.

Modeling the Economic Impact of Interventions for Older Populations with Multimorbidity: A Method of Linking Multiple Single-Disease Models.

Introduction. Individuals from older populations tend to have more than 1 health condition (multimorbidity). Current approaches to produce economic evidence for clinical guidelines using decision-analytic models typically use a single-disease approach, which may not appropriately reflect the competing risks within a population with multimorbidity. This study aims to demonstrate a proof-of-concept method of modeling multiple conditions in a single decision-analytic model to estimate the impact of multimorbidity on the cost-effectiveness of interventions. Methods. Multiple conditions were modeled within a single decision-analytic model by linking multiple single-disease models. Individual discrete event simulation models were developed to evaluate the cost-effectiveness of preventative interventions for a case study assuming a UK National Health Service perspective. The case study used 3 diseases (heart disease, Alzheimer's disease, and osteoporosis) that were combined within a single linked model. The linked model, with and without correlations between diseases incorporated, simulated the general population aged 45 years and older to compare results in terms of lifetime costs and quality-adjusted life-years (QALYs). Results. The estimated incremental costs and QALYs for health care interventions differed when 3 diseases were modeled simultaneously (£840; 0.234 QALYs) compared with aggregated results from 3 single-disease models (£408; 0.280QALYs). With correlations between diseases additionally incorporated, both absolute and incremental costs and QALY estimates changed in different directions, suggesting that the inclusion of correlations can alter model results. Discussion. Linking multiple single-disease models provides a methodological option for decision analysts who undertake research on populations with multimorbidity. It also has potential for wider applications in informing decisions on commissioning of health care services and long-term priority setting across diseases and health care programs through providing potentially more accurate estimations of the relative cost-effectiveness of interventions.

Gut microbiota and osteoarthritis management: An expert consensus of the European society for clinical and economic aspects of osteoporosis, osteoarthritis and musculoskeletal diseases (ESCEO).

The prevalence of osteoarthritis (OA) increases not only because of longer life expectancy but also because of the modern lifestyle, in particular physical inactivity and diets low in fiber and rich in sugar and saturated fats, which promote chronic low-grade inflammation and obesity. Adverse alterations of the gut microbiota (GMB) composition, called microbial dysbiosis, may favor metabolic syndrome and inflammaging, two important components of OA onset and evolution. Considering the burden of OA and the need to define preventive and therapeutic interventions targeting the modifiable components of OA, an expert working group was convened by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) to review the potential contribution of GMB to OA. Such a contribution is supported by observational or dietary intervention studies in animal models of OA and in humans. In addition, several well-recognized risk factors of OA interact with GMB. Lastly, GMB is a critical determinant of drug metabolism and bioavailability and may influence the response to OA medications. Further research targeting GMB or its metabolites is needed to move the field of OA from symptomatic management to individualized interventions targeting its pathogenesis.

Incidence and costs of hip fractures in elderly Italian population: first regional-based assessment.

We analyzed for the first-time hospitalizations and costs for hip fractures in the elderly Italian population at the regional level from 2007 to 2014. The number of fractures and the overall costs increased, mainly due to people aged > 85 in all the Italian regions, although at different rates. OBJECTIVE: We aimed at evaluating the burden of hip fractures in elderly Italian population at the regional level. METHODS: We analyzed national hospitalizations records 2007-2014 to compute standardized hospitalizations rates (SHR) due to hip fractures per 10,000 inhabitants at the regional level and average annual percent change (AAPC), along with related costs. RESULTS: Hip fractures occurred in people over 65 years increased from 89,601 to 94,525 over 8 years. The overall increase in the number of hospitalizations is attributable only to people aged ≥85. Actually, in the 65-74 and 74-84 age groups, total hospitalizations decreased from 13,396 to 12,268 and from 40,733 to 37,786 respectively, while they increased from 35,472 to 44,471 in people aged ≥85 (women = 28,605 and men = 6,867 in 2007; women = 34,636 and men = 9,835 in 2014). Almost 50% of hip fractures were found to have been experienced by patients aged 85 or older in 2014 (with women ≥ 85 representing 36.6% of total fractures), in accordance with the higher prevalence of osteoporosis in this age group. Fractures increase in people aged ≥ 85 was two-folds higher in males (AAPC: + 5.0%; P > 0.05) than in females (AAPC: + 2.6%; P > 0.05). Increases in the number of hospitalizations and related costs were observed for all the regions, with the only exception of Lazio (AAPC: - 4.6%; P < 0.05) and Friuli Venezia Giulia (hip fractures AAPC: - 1.9%; P < 0.05). The most significant increases in hip fractures and related costs were recorded in Calabria (+ 2.7%), Campania (+ 2.2%), and Lombardia (+ 2.0%). At the national level, SHR per 10,000 inhabitants due to hip fractures decreased in all three examined age groups (65-74, 75-84, and ≥ 85), both in males and females during the 8-year period (P < 0.05). This reduction was confirmed also when looking at the regional dataset, with few exceptions concerning female population (AAPC not statistically significant). When looking at the SHR per 10,000 inhabitants for the entire nation, we recorded a decreasing trend also in females aged 85 years old and over but not in males ≥ 85. Actually, men aged ≥ 85 showed increased HR per 10,000 in 10 regions out of 20. Direct hospitalization and rehabilitation costs increased in all the regions over the 8-year period (although at different rates), except for Friuli Venezia Giulia (where costs decreased from 21 to 19 million Euros) and Lazio (from 107 to 87 million Euros). Lombardia and Piemonte were the regions spending the highest amount of money to treat hip fractures in elderly people (151 and 95 million Euros in the year 2014, respectively). CONCLUSION: Hip fractures in the elderly population remain a major public health issue in all Italian regions, especially in people aged 85 years old and over, although the problem is starting to become more controlled compared with the past. Women represent the majority of hip fractures, but the highest increasing rate has been observed in men. Pilot projects at regional level targeting elderly people at higher risk of fractures and treatment compliance are needed.

Efficacy, cost, and aspects to take into account in the treatment of osteoporosis in the elderly / Eficacia, coste y aspectos a tener en cuenta sobre el tratamiento de la osteoporosis en el anciano

Age is one of the principal risk factors for development of frailty fractures. Age pyramids show a population that is becoming increasingly more elderly, with an increasing incidence of fractures, and the forecasts for the future are truly alarming. Adequate handling of these patients who are especially at risk, at both the preventive and care levels, with a well-defined orthogeriatric model is necessary to respond to this clinical challenge. The objective of this review is to analyze the efficacy of the different strategies for the handling of geriatric patients with fracture risk

La edad es uno de los principales factores de riesgo para desarrollar una fractura por fragilidad. Las pirámides de edad muestran una población cada vez más envejecida y la incidencia de fracturas es cada vez mayor, siendo las previsiones para el futuro verdaderamente preocupantes. Un adecuado manejo de estos pacientes de especial riesgo, tanto a nivel preventivo como asistencial con un modelo ortogeriátrico bien definido se hacen necesarias para hacer frente a este reto clínico. En esta revisión queremos realizar un análisis de la eficacia de las diferentes estrategias de manejo del paciente geriátrico con riesgo de fractura

Recommendations for the Reporting of Harms in Manuscripts on Clinical Trials Assessing Osteoarthritis Drugs: A Consensus Statement from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

BACKGROUND: There is strong evidence of under-reporting of harms in manuscripts on randomized controlled trials (RCTs) compared with the volume of raw data retrieved from these trials. Many guidelines have been developed to tackle this, but they have failed to address some important issues that would allow for standardization and transparency. As a consequence, harms reporting in manuscripts remains suboptimal. OBJECTIVE: The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) aimed to deliver accurate recommendations for better reporting of harms in clinical trials manuscripts on anti-osteoarthritis (OA) drugs. These could help to better inform clinicians on harms recorded in RCTs and further help researchers conducting meta-analyses. METHODS: Using the outcomes of several systematic reviews on the safety of anti-OA drugs, we summarized the ways in which harms have been reported in OA RCT manuscripts to date. Next, we drafted some recommendations and initiated a modified Delphi process that involved a panel of clinicians and clinical researchers to build an expert consensus on recommendations from the ESCEO for the reporting of harms in future manuscripts on RCTs assessing anti-OA drugs. RESULTS: These recommendations emphasize that all treatment-emergent adverse events (AEs) should always be taken into account for harms reporting, with no frequency threshold, and describe how specific AEs should be reported; they also provide a list of the most relevant organ systems to be considered according to each class of drug for reporting of harms within the results section of a manuscript. Irrespective of the drug, the ESCEO recommends that total, severe and serious AEs and withdrawals due to AEs should always be reported; guidance on the reporting of specific events pertaining to each category is provided. The ESCEO also recommends the reporting of information on drug effect on biological parameters, with specific guidance. CONCLUSIONS: These recommendations may contribute to improve transparency in the field of safety of anti-OA medications. Pharmaceutical companies developing drugs for OA, and researchers conducting clinical trials, are encouraged to comply with them when reporting harms-related results in manuscripts on RCTs. The ESCEO also encourages journals to refer to the ESCEO recommendations in their instructions to authors for the publication of manuscripts on trials of anti-OA medications.

Practical guidance for engaging patients in health research, treatment guidelines and regulatory processes: results of an expert group meeting organized by the World Health Organization (WHO) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

There is increasing emphasis on patient-centred research to support the development, approval and reimbursement of health interventions that best meet patients' needs. However, there is currently little guidance on how meaningful patient engagement may be achieved. An expert working group, representing a wide range of stakeholders and disciplines, was convened by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the World Health Organization (WHO). Through a structured, collaborative process the group generated practical guidance to facilitate optimal patient engagement in clinical development and regulatory decisions. Patient engagement is a relational process. The principles outlined in this report were based on lessons learned through applied experience and on an extensive dialogue among the expert participants. This practice guidance forms a starting point from which tailoring of the approach to suit different chronic diseases may be undertaken.

Healthcare Resource Utilization and Direct Medical Costs for Patients With Osteoporotic Fractures in China.

OBJECTIVES: To estimate annual healthcare resource utilization and direct medical costs for patients with osteoporotic fractures in China. METHODS: Data were obtained from the Tianjin Urban Employee Basic Medical Insurance database (2008-2011). Included patients were 50 years or older with one or more diagnoses of osteoporotic fractures between 2009 and 2010. The annual healthcare resource utilization and direct medical costs were estimated. Regression model was applied to identify factors associated with the direct medical costs. RESULTS: A total of 5941 patients were included (mean age, 65.9 years; women, 62.1%; retired, 88.2%). During the 12 months after a fracture, the annual mean all-cause cost was $2549 per patient. Osteoporosis-related costs accounted for 53.8% of the total costs; 92.0% of these costs were for inpatient services. For osteoporosis-related health services, 33.2% of the patients experienced at least 1 hospitalization, with a mean cost of $3010 per admission; 83.2% of the patients experienced at least 1 outpatient visit, with a mean cost of $18 per visit during the 12-month follow-up period. The regression model revealed that osteoporosis-related costs tended to increase with age, and patients with hip, vertebral, lower leg, and multiple fractures were more likely to have higher costs. CONCLUSIONS: Costs for patients with osteoporotic fractures were considerable in China, driven mainly by osteoporosis-related hospitalizations. Efforts focused on reducing the utilization of inpatient services by lowering the fracture risks may lighten the economic burden of osteoporotic fractures in China.