Recommendations for the conduct of clinical trials for drugs to treat or prevent sarcopenia
Aging Clin Exp Res
Recommendations for the conduct of clinical trials for drugs to treat or prevent sarcopenia
Jean-Yves Reginster 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Cyrus Cooper 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Rene´ Rizzoli 0 1 2 3 4 5 6 7 8 9 10 11 12 13
John A. Kanis 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Geoff Appelboom 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Ivan Bautmans 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Heike A. Bischoff-Ferrari 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Maarten Boers 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Maria Luisa Brandi 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Olivier Bruye`re 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Antonio Cherubini 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Bruno Flamion 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Roger A. Fielding 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Andrea Ildiko Gasparik 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Luc Van Loon 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Eugene McCloskey 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Bruce H. Mitlak 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Alberto Pilotto 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Suzanne Reiter-Niesert 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Yves Rolland 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Yannis Tsouderos 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Marjolein Visser 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Alfonso J. Cruz-Jentoft 0 1 2 3 4 5 6 7 8 9 10 11 12 13
0 MRC Lifecourse Epidemiology Unit, University of Southampton , Southampton , UK
1 Research Unit of Molecular Physiology (URPHYM), NARILIS, University of Namur , Namur , Belgium
2 Department of Public Health, Epidemiology and Health Economics, University of Liege , CHU Sart Tilman B23, 4000 Lie`ge , Belgium
3 Geriatrics and Geriatric Emergency Care, IRCCS-INRCA , Ancona , Italy
4 Department of Public Health and Health Management, University of Medicine and Pharmacy of Tirgu Mures , Tirgu Mures , Romania
5 & Olivier Bruye`re
6 Nutrition, Exercise Physiology and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University , Boston , USA
7 Department of Internal Medicine, University of Florence , Florence , Italy
8 Department of Epidemiology and Biostatistics; and Amsterdam Rheumatology and Immunology Center, VU University Medical Center , Amsterdam , Netherlands
9 Gerontology and Frailty in Ageing Research Department, Vrije Universiteit Brussel (VUB) , Brussels , Belgium
10 Columbia University Medical Center, The Neurological Institute , New York , USA
11 Centre for Metabolic Bone Diseases, and Centre for Integrated Research in Musculoskeletal Ageing, University of Sheffield , Sheffield , UK
12 Service of Bone Diseases, Geneva University Hospitals and Faculty of Medicine , Geneva , Switzerland
13 NIHR Musculoskeletal Biomedical Research Unit, University of Oxford , Oxford , UK
Purpose Sarcopenia is an age-related muscle condition which is frequently a precursor of frailty, mobility disA multidisciplinary expert working group was ability and premature death. It has a high prevalence in hosted by the European Society for Clinical and Economic older populations and presents a considerable social and Aspects ment of pharmaceutical treatments for that indication. Results
Osteoporosis
-
and
Osteoarthritis,
which
economic burden. Potential treatments are under
developreviewed and discussed the recent literature from a
perment but, as yet, no guidelines support regulatory studies
spective of clinical experience and guideline development.
for new drugs to manage sarcopenia. The objective of this
Relevant parallels were drawn from the development of
position paper is therefore to suggest a set of potential
definition of osteoporosis as a disease and clinical
assessendpoints and target population definitions to stimulate
debate and progress within the medico-scientific and
regulatory communities.
Methods
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
8
9
Department of Geriatrics, University Hospital of Zurich,
Zurich, Switzerland
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.
Sarcopenia Public health
Frailty
Introduction
Sarcopenia is a syndrome characterised by progressive and
generalized loss of skeletal muscle mass and strength; it is
a major pathway leading to physical frailty [
1
]. Since, the
loss of muscle mass and strength is inherent in normal
ageing, the switch towards a pathological condition must
be established empirically, by the combination of
diagnostic thresholds and associated risk of mobility-related
outcomes, poor quality of life and death [
2–4
]. (...truncated)