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.
Biochemical markers; Biomarkers; Clinical trial; Pharmacological drugs; Recommendations; Sarcopenia; Endocrinology; Orthopedics and Sports Medicine; Endocrinology, Diabetes and Metabolism
Abstract :
[en] 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.
Disciplines :
Public health, health care sciences & services Laboratory medicine & medical technology
Author, co-author :
Ladang, Aurélie ; Centre Hospitalier Universitaire de Liège - CHU > > Service de chimie clinique
Beaudart, Charlotte ; Centre Hospitalier Universitaire de Liège - CHU > > Service de médecine de l'appareil locomoteur
Reginster, Jean-Yves ; Université de Liège - ULiège > Département des sciences de la santé publique ; Biochemistry Department, College of Science, Chair for Biomarkers of Chronic Diseases, King Saud University, Riyadh, 11451, Saudi Arabia
Al-Daghri, Nasser; Biochemistry Department, College of Science, Chair for Biomarkers of Chronic Diseases, King Saud University, Riyadh, 11451, Saudi Arabia
Bruyère, Olivier ; Centre Hospitalier Universitaire de Liège - CHU > > Service de médecine de l'appareil locomoteur
Burlet, Nansa ; Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
Cesari, Matteo; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy ; Geriatric Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
Mobasheri, Ali; Division of Public Health, Epidemiology and Health Economics, WHO Collaborating Center for Public Health Aspects of Musculo-Skeletal Health and Ageing,, University of Liège, Liège, Belgium ; State Research Institute Centre for Innovative Medicine, Vilnius, Lithuania ; Research Unit of Medical Imaging, Physics and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland ; Department of Joint Surgery, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China
Ormarsdottir, Sif; Landspitali, University Hospital of Iceland, Reykjavik, Iceland
Radermecker, Régis ; Centre Hospitalier Universitaire de Liège - CHU > > Service de diabétologie, nutrition, maladies métaboliques
Visser, Marjolein; Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
Yerro, Maria Concepcion Prieto; Agencia Española de Medicamentos Y Productos Sanitarios, Madrid, Spain
Rizzoli, René; Faculty of Medicine, Service of Bone Diseases, Geneva University Hospitals, Geneva, Switzerland
Cavalier, Etienne ; Centre Hospitalier Universitaire de Liège - CHU > > Service de chimie clinique
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.
Publication date :
12 January 2023
Journal title :
Calcified Tissue International
ISSN :
0171-967X
eISSN :
1432-0827
Publisher :
Springer Science and Business Media LLC, United States
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