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Title: Recommendations for the conduct of clinical trials for drugs to treat or prevent sarcopenia

item REGINSTER, JEAN-YVES - University Of Liege
item COOPER, CYRUS - University Of Oxford
item RIZZOLI, RENE - Geneva University Hospital
item KANIS, JOHN - University Of Sheffield
item APPELBOOM, GEOFF - Columbia University Medical Center
item BAUTMANS, IVAN - Vrije University
item BISCHOFF-FERRARI, HEIKE - University Hospital Zurich
item BOERS, MAARTNE - Vu University Medical Center
item BRANDI, MARTA LUISA - University Of Florence
item BRUYERE, OLIVIER - University Of Liege
item CHERUBINI, ANTONIO - Institute Of Hospitalization And Care Scientific - National Institute Of Rest And Elderly Care
item FLAMION, BRUNO - University Of Namur
item FIELDING, ROGER - Jean Mayer Human Nutrition Research Center On Aging At Tufts University
item GASPARIK, ANDREA ILDIKO - University Of Medicine And Pharmacy Of Tirgu Mure
item VAN LOON, LUC - Maastricht University
item MCCLOSKEY, EUGENE - University Of Sheffield
item MITLAK, BRUCE - Eli Lilly & Company
item PILOTTO, ALBERTO - Galliera Hospital
item REITER-NIESERT, SUZANNE - German Society For Rheumatology Association
item ROLLAND, YVES - University Of Toulouse
item TSOUDEROS, YANNIS - Servier International Research Institute
item VISSER, MARJOLEIN - Vu University Medical Center
item CRUZ-JENTOFT, ALFONSO - Service Geriatric Hospital

Submitted to: Aging Clinical Experimental Research
Publication Type: Review Article
Publication Acceptance Date: 12/6/2015
Publication Date: 2/28/2016
Citation: Reginster, J., Cooper, C., Rizzoli, R., Kanis, J.A., Appelboom, G., Bautmans, I., Bischoff-Ferrari, H.A., Boers, M., Brandi, M., Bruyere, O., Cherubini, A., Flamion, B., Fielding, R.A., Gasparik, A., Van Loon, L., Mccloskey, E., Mitlak, B.H., Pilotto, A., Reiter-Niesert, S., Rolland, Y., Tsouderos, Y., Visser, M., Cruz-Jentoft, A.J. 2016. Recommendations for the conduct of clinical trials for drugs to treat or prevent sarcopenia. Aging Clinical Experimental Research. 28(1):47-58. doi: 10.1007/s40520-015-0517-y.

Interpretive Summary:

Technical Abstract: 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 presents a considerable social and economic burden. Potential treatments are under development but, as yet, no guidelines support regulatory studies for new drugs 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 medico scientific and regulatory communities. METHODS: A multidisciplinary expert working group was hosted by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, which reviewed and discussed the recent literature from a perspective of clinical experience and guideline development. Relevant parallels were drawn from the development of definition of 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.