Osteoporos Int (2015) 26 (Suppl 1):S57–S62 DOI 10.1007/s00198-015-3061-x
World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO 2015): ESCEO Symposia Abstracts
# International Osteoporosis Foundation and National Osteoporosis Foundation 2015
SE1 INTEGRATED APPROACH TO PREVENT REFRACTURE: THE FRACTURE UNIT PROJECT OF THE ORTOMED SCIENTIFIC SOCIETY L. Cianferotti1, M. L. Brandi1 1 Department of Surgery and Translational Medicine, University of Florence, Florence, Italy Hip fractures are serious events often leading to long-term functional impairment, nursing home admission, increased major morbidity and mortality and representing a heavy financial burden for healthcare systems. The risk of a re-fracture after a hip fracture is high (up to 20 % within two years). An appropriate management for bone health can decrease refracture rate after the first major event. Accordingly, secondary prevention must be routine care for hip fracture patients. Unfortunately, secondary prevention is poorly addressed in surgery departments, where patients are discharged without osteoporosis assessment and proper therapeutic indications. In this respect, the objective of the Fracture Unit Project endorsed by the Italian Society of Orthopaedics and Medicine (OrtoMed) has been to assess the feasibility and the efficacy of a systematic model of care for elderly patients (≥65 years of age) admitted in hospital for a hip fracture. The core of each Fracture Unit is the closed collaboration between the orthopaedic surgeon and the bone specialist, who is ultimately responsible for the diagnostic workflow and the subsequent antifracture treatment for the patient. This program has been run in eight university hospitals distributed throughout Italy in three phases: 1) establishment and implementation of the Fracture Unit in clinical practice; 2) enrolment, follow-up of 900 patients admitted for a hip fracture within the three months after the constitution of the integrated care model; 3) retrospective study on the subjects admitted for a hip fractures in the three months preceding the setting up of the Fracture Unit (considered as the control group). A comparison of key performance indicators has been performed, in order to assess the efficacy of the implementation program versus the usual
care. The analysis has shown a significant increase in the percentage of patients for which a secondary diagnostictherapeutic prevention program within the Fracture Unit has been established. In a subgroup of subjects enrolled in the program, a significant increase in the appropriateness of prescribed treatments and an improvement in adherence up to 12 months after the hip fracture has been demonstrated, independently of confounding factors. A parallel project, named T.A.R.Ge.T. (Trattamento Appropriato delle Rifratture Geriatriche in Toscana, i.e. “Appropriate treatment of geriatric refractures in Tuscany”) has been run to get information for statistical and epidemiological analyses. For this purpose, data have been retrieved from the individual anonymous Regional Prescription Database, which has been built and administered by the Region of Tuscany to monitor and control health expenditure. In conclusion, the constitution of a multidisciplinary model of care such as the Fracture Unit has been shown to be feasible in all the participating Centres and able to ameliorate the diagnostic-therapeutic procedures in elderly subjects with a hip fracture, increasing both the appropriateness and the adherence to anti-osteoporotic medication aimed to secondary fracture prevention.
SE2 ANTIOSTEOPOROTIC DRUGS AND THEIR REIMBURSEMENT IN ITALY R. Nuti1 1 Department of Medicine Surgery and Neurosciences University of Siena Italy, Siena, Italy Osteoporosis treatment should be aimed at reducing the risk of fracture. The use of drugs is always associated with potential risks so their use should be reserved for patients at higher risk, for which there is adequate documentation of efficacy. The use of drugs is also influenced by the relationship between the advantages and disadvantages, whose individual estimate is often complex and must take into account important social
and economic aspects. In Italy the note 79 provides the criteria for the reimbursement of the pharmacological treatment of osteoporosis by the SSN for patients with high risk of fracture. Patients with a history of osteoporotic fractures are most at risk for further fractures (>20 % at 10 years). Additional criteria for the reimbursement of the drug in Italy are low values of BMD measured by DXA or reduced QUS values associated with additional risk factors such as family history of vertebral and/or femoral fractures, rheumatoid arthritis and other connective tissue disorders, previous osteoporotic wrist fracture, early menopause. In these cases, patients may be treated with bisphosphonates, SERMs, strontium ranelate associated with supplementation of calcium and vitamin D. A further condition of similar risk has also been documented for patients >50 years in chronic corticosteroid treatment. The documentation of efficacy for some drugs in this type of secondary osteoporosis therefore justifies the extension of Note 79 to women and men being treated with medium to high doses of corticosteroids. Moreover, the parathyroid hormone and teriparatide are reserved for patients with severe osteoporosis and high risk of new fragility fractures. This level of risk is identified by the presence of multiple or severe vertebral fractures and/or by the appearance of new fractures after a reasonable period of therapy with other drugs. The note states that a patient can be in note 79 to teriparatide or parathyroid in case of multiple previous moderate-severe vertebral or femoral fractures or, limited to teriparatide, if there are previous moderate-severe fractures and the patient is on chronic steroid therapy. Recently, taking into account the new algorithms for estimating the risk of fracture, a revision of the note 79 has been proposed; it is currently under evaluation but certainly it will improve the therapeutic approach of osteoporotic patients.
SE3 THE ITALIAN SOCIETY OF ORTHOPAEDICS AND TRAUMATOLOGY (SIOT) IN THE MULTIDIMENSIONAL PATHWAY OF CLINICAL AND BIOLOGICAL KNOWLEDGE OF THE OSTEOARTICULAR SYSTEM U. Tarantino1, M. Feola1 1 Division of Orthopaedics and Traumatology, University of Tor Vergata, Rome, Italy Over the last 50 years in the world an aging population has being recorded with an increasing number of individuals over 65. In Italy in particular, they reached the 21 % of the entire population, growing by 17 % over the past 10 years, with an inevitable increase of incidence of chronic osteoarticular diseases. In particular osteoporosis and osteoarthritis compromise the quality of life of affected subjects in an important way. The aging population will result in a further increase in
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the incidence of these two diseases with a major impact on the economic health of our country. Different scientific societies tried to respond to this need of health by the elderly population through targeted initiatives to promote prevention and to identify patterns of treatment to improve the management of these patients. The Italian Society of Orthopaedics and Traumatology (SIOT) created a committee for research and technological innovation in which different committees work and act on different areas of the bone and joint diseases. The Osteoporosis and Orthogeriatrics Study Group works with other groups such as the Metabolic and Rare Diseases Study Group, the Appliances and Biomechanics Commission, the Studies on Biology and Tissue Regeneration Commission and the Trauma Center Study Group. These promote the application in medicine of the important scientific advances achieved in engineering and basic science. The study of new materials in the field of prosthetics, innovative osteoconductive or osteoinductive strategies and less invasive surgical techniques will allow to implement the options available to the orthopedic surgeon in the management of elderly patients with musculoskeletal disorders. The intense work of the various SIOT committees and collaboration between them will surely get more results, in line with the activities of other European and international scientific societies.
SE4 ACTIVITIES AND FUTURE PERSPECTIVES OF ITALIAN OSTEOPOROSIS AND METABOLIC BONE DISEASES SOCIETY (SIOMMMS) G. C. Isaia1 1 Unit of Geriatrics and Metabolic Bone Diseases. Molinette Hospital AO Città della Salute e della Scienza di Torino, Torino, Italy Italian Society for Osteoporosis and Metabolic Bone Diseases counts about 550 members; during the last year the society developed many activities aimed to spread knowledge about osteoporosis and bone metabolism diseases among medical personnel and awareness of osteoporosis negative consequences in the public opinion. The scientific society was reorganized by creating Regional and Interregional sections, lead by a coordinator, in order to increase local initiatives such as congresses, update courses, information campaigns and contacts with public authorities. Through dedicated Commissions, several initiatives were realized: − Considerable funding (€ 100000) has been allocated to two research projects (one in basic science and one in clinical research) and to a young researcher internship abroad. - Two update courses have been performed on a national basis, one addressed to doctors first approaching bone metabolism diseases, and one focused
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on more advanced topics. Every event included both basic science and clinical sections, in order to improve clinical approaches and therapy through better pathophysiology mechanisms comprehension. - The society got better visibility through a new website (www. siommms.it), with the support of a specialised communication company, allowing a closer contact with members and Italian doctors in general (about 1000 website visitors per week). The website hosts scientific updates and abstracts, case reports, congress programs, legislation updates, interviews to opinion leaders, the list of specialised centers affiliated to SIOMMMS. Members have free access to Calcified Tissue International and Osteoporosis International papers through the website. - Position papers and review collections (Syllabus) on particularly interesting topics are available on the website. - The National Congress took place in Rome in November 2014 with over 450 participants and joint session with other Italian scientific society and with the American Society for Bone and Mineral Research ASBMR. - A congress side event called “Fellow Day” allowed 10 young Italian researchers to meet American principal investigators and expose their projects, receiving basic science talks and feedback on their future research. During the next year, we aim to build an effective cultural alliance with General Practitioner, Orthopaedics, Rehabilitation physicians, out to improve appropriateness in diagnosis and therapy of Osteoporosis; moreover we will create a nursing section, to improve medical services to patients and support to national institutions through better knowledge diffusion to all medical personnel.
SE5 RECOMMENDATIONS FOR AN UPDATE OF THE CURRENT (2010) EUROPEAN REGULATORY GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS USED IN THE TREATMENT OF OSTEOARTHRITIS AND REFLECTIONS ABOUT RELATED CLINICALLY RELEVANT OUTCOMES J.-Y. Reginster1, S. Reiter-Niesert2, O. Bruyère1, F. Berenbaum3,4, M. L. Brandi5, J. Branco6,7, J.-P. Devogelaer8, G. Herrero-Beaumont9, J. A. Kanis10, S. Maggi11, E. Maheu12, P. Richette13, R. Rizzoli14, C. Cooper15,16 1 Department of Public Health Sciences, University of Liège and CHU Centre Ville, Liège, Belgium, 2 Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany, 3 Department of Rheumatology, AP-HP University Pierre and Marie Curie, Saint Antoine Hospital, Paris, France, 4 University of Paris 06, INSERM UMRS-938, Paris, France, 5 Department of Internal Medicine, University
of Florence, Florence, Italy, 6 CEDOC, Department of R h e u m a t o l o g y, F a cu l d ad e d e C i ê n ci a s M é d i ca s , Universidade Novade Lisboa, Lisbon, Portugal, 7CHLO, EPE, Hospital Egas Moniz, Lisbon, Portugal, 8 Department of Rheumatology, Saint-Luc University Hospital, Catholic University of Louvain, Louvain, Belgium, 9Bone and Joint Research Unit, Fundación Jiménez Díaz, Madrid, Spain, 10 Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Sheffield, United Kingdom, 11 Aging Program, National Research Council, Padova, Italy, 12Rheumatology, AP-HP, St. Antoine Hospital, Paris, France, 13Paris Diderot University, UFR médicale, AP-HP, Hôpital Lariboisière, fédération de Rhumatologie, Paris, France, 14 Division of Bone Diseases, Department of Rehabilitation and Geriatrics, University Hospital and Faculty of Medicine of Geneva, Geneva, Switzerland, 15 NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, United Kingdom, 16MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton General Hospital, Southampton, United Kingdom Objective: The European Society on Clinical and Economic aspects of Osteoporosis and Osteoarthritis (ESCEO) organised a working group to evaluate the need for updating the current European guideline on clinical investigation of drugs used in the treatment of osteoarthritis (OA). Material and Methods: Areas of potential attention were identified and the need for modifications, update or clarification was examined. Proposals were then developed based on literature reviews and through a consensus process. Results: It was agreed that the current guideline overall still reflects the current knowledge in OA, although two possible modifications were identified. The first relates to the number and timing of measurements required as primary endpoints during clinical trials of symptom-relieving drugs, either drugs with rapid onset of action or slow acting drugs. The suggested modifications are intended to take into consideration the time related clinical need and expected time response to these drugs - i.e. a more early effect for the first category in addition to the maintenance of effect, a more continuous benefit over the long-term for the latter - in the timing of assessments. Secondly, values above which a benefit over placebo should be considered clinically relevant were considered. Based on literature reviews, the most consensual values were determined for primary endpoints of both symptom-relieving drugs (i.e. pain intensity on a visual analogue scale) and diseasemodifying drugs (i.e. radiographic joint-space narrowing). Conclusion: This working document might be considered by the European regulatory authorities in a future update of the guideline for the registration of drugs in OA.
SE6 CURRENT REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS TO BE USED IN OSTEOARTHRITIS IN EUROPE AND NEED FOR CLARIFICATION J.-Y. Reginster1 1 Department of Public Health and Health Economics, University of Liège, Liège, Belgium The European Society for Clinical and Economical Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) organized a working group to evaluate the need for updating the current European guideline on clinical investigation of drugs used in the treatment of osteoarthritis. A first European regulatory document aimed at providing advice for the development of drugs in osteoarthritis was issued in 1998. The latest version of the EMA Guidance adopted in 2010 is a revision of that document. Several elements of the guidelines are the subject of much debate. They are many related to the cutoff values that should define the clinically relevant symptomatic or structural improvement and to the timing of assessments that should be collected throughout confirmatory clinical trials. The consensus of the ESCEO working group, which might be possibly considered in future guidelines, will be presented during the discussion of this paper.
SE7 TRABECULAR BONE SCORE (TBS) AS A NEW COMPLEMENTARY APPROACH FOR OSTEOPOROSIS EVALUATION IN CLINICAL PRACTICE N. C. Harvey1, N. Binkley2, M. L. Brandi3, B. Camargos4, C. Cooper1, C. C. Glüer5, J.A. Kanis6, D. L. Kendler7, O. Lamy8, A. Laslop9, J.-Y. Reginster10, R. Rizzoli11 1 MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom, 2 University of Wisconsin, Madison, Wisconsin, United States, 3University of Florence, Florence, Italy, 4 IOF Latin America Regional Advisory Committee, ISCD Iberian American Panel Chair, Belo Horizonte, Brazil, 5Biomedical Imaging, Diagnostic Radiology, University of Kiel, Kiel, Germany, 6WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, United Kingdom, 7 University of British Columbia, Vancouver, Canada, 8Lausanne University Hospital, Center of Bone Diseases, Lausanne, Switzerland, 9Department of Pharmacology, University of Innsbruck, Innsbruck, Austria, 10Department of Public Health Sciences, University of Liège and CHU Centre Ville, Liège, Belgium, 11Division of Bone Diseases, Department of Rehabilitation and Geriatrics,
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University Hospital and Faculty of Medicine of Geneva, Geneva, Switzerland TBS is a novel analytical tool that performs grey-level texture measurements on lumbar spine DXA images, appearing to capture information relating to trabecular microarchitectural indices. In this symposium, findings of a comprehensive literature review relating TBS to fracture risk assessment, performed by a Working Group of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, will be presented. Thus, studies have demonstrated associations between low TBS and an increase in both past and incident fractures, with relationships appearing at least partly independent of BMD. Further investigations have documented modest changes in TBS with osteoporosis treatment, but that the magnitude of this change is much lower than that of lumbar spine BMD; it is currently not clear how change in TBS relates to fracture risk reduction. Finally, recent work has suggested that TBS might have an adjunctive role in assessment of fracture probability using the FRAX algorithm. In conclusion, evidence in support of a potential role of TBS in fracture risk assessment is accruing. However, further exploration and validation of TBS-based approaches in prospective studies are required to inform optimal use of TBS in routine clinical assessment of fracture risk.
SE8 GLUCOSAMINE AND CHONDROITIN SALTS IN THE MANAGEMENT OF OSTEOARTHRITIS IN EUROPE J.-Y. Reginster1 1 Department of Public Health and Health Economics, University of Liège, Liège, Belgium Despite the near concurrent publication by influential scientific organizations in rheumatology of guidelines for the management of knee osteoarthritis, there are important differences in interpretation of the evidence base and the conclusions derived therefrom. These differences may arise in part from the different regulatory status for same treatments in the USA compared to Europe. This is particularly evident for glucosamine sulfate and chondroitin sulfate. In Europe and in several other countries, the original products (crystalline glucosamine sulfate and chondroitin sulfate) are available, are of pharmaceutical grade and are approved by the European Medicines Agency or the relevant competent authorities as prescription drugs. ESCEO recommend prescription chondroitin sulfate and/or glucosamine sulfate as chronic background treatment in the first step of its algorithm
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guidelines for the management of knee osteoarthritis, based on the available evidence.
SE9 HYALURONIC ACID SALTS IN THE MANAGEMENT OF OSTEOARTHRITIS IN EUROPE J.-P. Pelletier1 1 Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Montreal, Quebec, Canada The treatment of osteoarthritis (OA) often requires the use of both non-pharmacological and pharmacological agents. The latter includes drugs/agents that may be administered systematically or locally. Among locally administered pharmacological agents, corticosteroids and hyaluronic acid (HA) are by far the most commonly used. Hyaluronic acid is a naturally occurring polysaccharide compound with viscoelastic properties responsible for water retention and cushioning as well as lubrication of the joint. In OA, the mode of action of HA injections is believed to be mediated through an antiinflammatory action. Hyaluronic acid has been demonstrated to be an effective treatment for knee OA in a number of clinical trials. The clinical activity onset and duration of action as well as safety, which is generally very good, may vary between treatments and could be related to a number of factors such as the composition and/or molecular weight of HA. The results of several meta-analyses on the benefits of HA therapy, more specifically, the recent review of meta-analyses by Campbell et al. (1) and the recent Cochrane report (2), are supportive that viscosupplementation in knee OA provides long term positive benefits (up to 6 months) for pain and function. Viscosupplementation with HA has a low risk of significant side effects. However, until now, there has been no definite proof that viscosupplementation may have disease modifying properties. Moreover, it has been demonstrated in a number of studies that the treatment can retard the indication for total joint replacement. In summary, viscosupplementation provides a positive risk/benefit therapeutic option for the treatment of knee OA. It could be particularly useful in patients who have failed other therapeutic options and/or in patients with monoarticular presentation of osteoarthritis of the knee. References: 1. Campbell J et al., Osteoarthritis Cartilage 2007;14:1424. 2. Evaniew N, Simunovic N, Clin Orthop Relat Res 2014;472:2028. Disclosures: Dr Pelletier is a shareholder in ArthroLab Inc. and consultant for AbbVie, Bioiberica, Elanco, Endocyte, Ferring, Merck & Co., Pfizer, Servier, TRB Chemedica.
SE10 CAN WE IDENTIFY PATIENTS TO BE TREATED IN OSTEOARTHRITIS? N. K. Arden1, P. Richette 2, C. Cooper 3,4, O. Bruyère5, E. Abadie6, J. Branco7,8, M. L. Brandi9, F. Berenbaum10,11, C. Clerc12, E. Dennison3,4, J.-P. Devogelaer13, M. Hochberg14, G. Herrero-Beaumont 15 , J.A. Kanis 16 , A. Laslop 17 , V. Leblanc18, S. Maggi19, G. Mautone20, J.-P. Pelletier21, F. Petit-Dop22, S. Reiter-Niesert23, R. Rizzoli24, L. Rovati25, E. Tajana 2 1 , Y. Tsouderos 2 2 , J. Martel-Pelletier 2 1 , J.-Y. Reginster5 1 NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, ARUK Sports, Exercice and Osteoarthritis centre of Excellence, Oxford, United Kingdom, 2Paris Diderot University, UFR médicale, AP-HP, Hôpital Lariboisière, fédération de Rhumatologie, Paris, France, 3NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, Oxford, United Kingdom, 4MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, United Kingdom, 5Department of Public Health Sciences, University of Liège and CHU Centre Ville, Liège, Belgium, 6Division of Cardiology, Ambroise Paré Hospital, Paris, France, 7CEDOC, Department of Rheumatology, Faculdade de Ciências Médicas, Universidade Novade Lisboa, Lisbon, Portugal, 8CHLO, EPE, Hospital Egas Moniz, Lisbon, Portugal, 9Department of Internal Medicine, University of Florence, Florence, Italy, 10 Department of Rheumatology, AP-HP University Pierre and Marie Curie, Siant Antoine Hospital, Paris, France, 11 University of Paris 06, INSERM UMRS-938, Paris, France,12Laboratoires Genevrier, Antibes, France, 13Department of Rheumatology, Saint-Luc University Hospital, Catholic University, Louvain, Belgium, 14Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Maryland School of Medicine, and Acting Director, Geriatric Research, Education and Clinical Center, Maryland VA Health Care System, Baltimore, United States, 15Bone and Joint Research Unit, Fundación Jiménez Díaz, Madrid, Spain, 16 WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Sheffield, United Kingdom, 17Department of Pharmacology, University of Innsbruck, Innsbruck, Austria, 18Expanscience Laboratoires, Courbevoie, France, 19Aging Program, National Research Council, Padova, Italy, 20IBSA Institut Biochimique SA Via del Piano, Pambio-Noranco, Switzerland, 21Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Montreal, Quebec, Canada, 22 Institut de Recherches Internationales Servier, Suresnes, France, 23Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany, 24Division of Bone Diseases, Department of Rehabilitation and Geriatrics, University Hospital and Faculty of Medicine of Geneva, Geneva, Switzerland, 25Clinical Research Unit, Rottapharm/Madaus, Monza, Italy
Objective: Osteoarthritis (OA), a disease affecting different patient phenotypes, appears as an optimal candidate for personalized health care. The aim of the discussions of the European Society on Clinical and Economic aspects of Osteoporosis and Osteoarthritis (ESCEO) working group was to explore the value of markers of different sources in defining different phenotypes of patients with OA. Material and Methods: The ESCEO organised a series of meetings to explore the possibility of identifying patients who would most benefit from treatment for OA, on the basis of recent data and expert opinion. In a first meeting, patient phenotypes were identified according to the number of affected joints, biomechanical factors and the presence of lesions in the subchondral bone. In a second meeting summarised in the present article, the working group explored other markers involved in OA. Results: Profiles of patients may be defined according to their level of pain, functional limitation and presence of coexistent chronic conditions including frailty status. A number of data suggest that magnetic resonance imaging may also assist in delineating different phenotypes of patients with OA. Among multiple biochemical biomarkers identified, none is sufficiently validated and recognised to identify patients who should be treated. Considerable efforts are also being made to identify genetic and epigenetic factors involved in OA, but results are still limited. Conclusion: The many potential markers that could be used as potential stratifiers are promising, but more research is needed to characterize and qualify the existing biomarkers and in identifying new candidates.
SE11 RECOMMENDATIONS FOR THE REGISTRATION OF DRUGS TO TREAT SARCOPENIA J.-Y. Reginster1, C. Cooper2, R. Rizzoli3, J. A. Kanis4, G. Appelboom5, I. Bautmans6, H. A. Bischoff- Ferrari7, M. Boers8, M. L. Brandi9, O. Bruyère1, A. Cherubini10, B. Flamion11, R. Fielding12, L. Van Loon13, E. V. McCloskey14, B. Mitlak15, A. Pilotto16, S. Reiter-Niesert17, Y. Rolland18, Y. Tsouderos19, M. Visser20, A. J. Cruz-Jentoft21 1 Department of Public Health and Health Economics, University of Liège, Liège, Belgium, 2MRC Lifecourse Epidemiology Unit, Southampton General Hospital, Southampton, United Kingdom, 3 University Hospitals, Geneva, Switzerland, 4 University of Sheffield Medical School, Sheffield, United Kingdom, 5Department of Neurological Surgery, Columbia University Medical Center, New-York, United States, 6Frailty in Ageing research department, Vrije Universiteit Brussel, Brussel, Belgium, 7Geriatrics and Aging Research, University Hospital Zurich, Zurich, Switzerland, 8 Department of
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Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, Netherlands, 9University of Florence, Florence, Italy, 10Department of Geriatry, INRCA, Ancona, Italy, 11 University of Namur, Namur, Belgium, 12 Nutrition, Exercise, Physiology, and Sarcopenia Laboratory Jean Mayer USDA Human Nutrition Research Center on Aging Tufts University, Boston, MA, United States, 13Department of Human Movement Sciences, Maastricht University Medical Center, Maastricht, Netherlands, 14University of Sheffield, Sheffield, United Kingdom, 15Eli Lilly and Company, Indianapolis, United States, 16Geriatrics Unit, Azienda ULSS 16 Padova, Padova, Italy, 17Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany, 18Clinical Gerontology, CHU Toulouse, Toulouse, France, 19Institut de Recherches Internationales Servier, Suresnes, France, 20VU University and VU University Medical Center, Amsterdam, Netherlands, 21 Department of Geriatry, University Hospital Ramón y Cajal, Madrid, Spain Purpose: Sarcopenia is an age-related muscle condition which is frequently a precursor of frailty, mobility disability and premature death. It has a high prevalence in older populations and therefore presents a considerable social and economic burden. Potential treatments are under development but, as yet, there are no guidelines to support regulatory studies for new drugs developed to manage sarcopenia. The objective of this position paper is therefore to suggest a set of potential endpoints and target population definitions to stimulate debate and progress within the medicoscientific and regulatory communities. Methods: A multidisciplinary expert working group was hosted by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO), which reviewed and discussed the recent literature from a perspective of clinical experience and regulatory guideline development. Relevant parallels were drawn from the development of definition osteoporosis as a disease and clinical assessment of pharmaceutical treatments for that indication. Results: A case-finding decision tree is briefly reviewed with a discussion of recent prevalence estimations of different relevant threshold values. The selection criteria for patients in regulatory studies are discussed according to the aims of the investigation (sarcopenia prevention or treatment) and the stage of project development. The possible endpoints of such studies are reviewed and a plea is made for the establishment of a core outcome set to be used in all clinical trials of sarcopenia. Conclusions: The current lack of guidelines for the assessment of new therapeutic treatments for sarcopenia could potentially hinder the delivery of effective medicines to patients at risk.