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Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults

BACKGROUND: In 2016, an expert working group was convened under the auspices of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and formulated consensus recommendations for the conduct of clinical trials for drugs to prevent or treat sarcopenia. AIMS...

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Autores principales: Reginster, Jean-Yves, Beaudart, Charlotte, Al-Daghri, Nasser, Avouac, Bernard, Bauer, Jürgen, Bere, Nathalie, Bruyère, Olivier, Cerreta, Francesca, Cesari, Matteo, Rosa, Mario Miguel, Cooper, Cyrus, Cruz Jentoft, Alfonso J., Dennison, Elaine, Geerinck, Anton, Gielen, Evelien, Landi, Francesco, Laslop, Andrea, Maggi, Stefania, Prieto Yerro, María Concepción, Rizzoli, René, Sundseth, Hildrun, Sieber, Cornel, Trombetti, Andrea, Vellas, Bruno, Veronese, Nicola, Visser, Marjolein, Vlaskovska, Mila, Fielding, Roger A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7897619/
https://www.ncbi.nlm.nih.gov/pubmed/32737844
http://dx.doi.org/10.1007/s40520-020-01663-4
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author Reginster, Jean-Yves
Beaudart, Charlotte
Al-Daghri, Nasser
Avouac, Bernard
Bauer, Jürgen
Bere, Nathalie
Bruyère, Olivier
Cerreta, Francesca
Cesari, Matteo
Rosa, Mario Miguel
Cooper, Cyrus
Cruz Jentoft, Alfonso J.
Dennison, Elaine
Geerinck, Anton
Gielen, Evelien
Landi, Francesco
Laslop, Andrea
Maggi, Stefania
Prieto Yerro, María Concepción
Rizzoli, René
Sundseth, Hildrun
Sieber, Cornel
Trombetti, Andrea
Vellas, Bruno
Veronese, Nicola
Visser, Marjolein
Vlaskovska, Mila
Fielding, Roger A.
author_facet Reginster, Jean-Yves
Beaudart, Charlotte
Al-Daghri, Nasser
Avouac, Bernard
Bauer, Jürgen
Bere, Nathalie
Bruyère, Olivier
Cerreta, Francesca
Cesari, Matteo
Rosa, Mario Miguel
Cooper, Cyrus
Cruz Jentoft, Alfonso J.
Dennison, Elaine
Geerinck, Anton
Gielen, Evelien
Landi, Francesco
Laslop, Andrea
Maggi, Stefania
Prieto Yerro, María Concepción
Rizzoli, René
Sundseth, Hildrun
Sieber, Cornel
Trombetti, Andrea
Vellas, Bruno
Veronese, Nicola
Visser, Marjolein
Vlaskovska, Mila
Fielding, Roger A.
author_sort Reginster, Jean-Yves
collection PubMed
description BACKGROUND: In 2016, an expert working group was convened under the auspices of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and formulated consensus recommendations for the conduct of clinical trials for drugs to prevent or treat sarcopenia. AIMS: The objective of the current paper is to provide a 2020 update of the previous recommendations in accordance with the evidence that has become available since our original recommendations. METHODS: This paper is based on literature reviews performed by members of the ESCEO working group and followed up with face to face meetings organized for the whole group to make amendments and discuss further recommendations. RESULTS: The randomized placebo-controlled double-blind parallel-arm drug clinical trials should be the design of choice for both phase II and III trials. Treatment and follow-up should run at least 6 months for phase II and 12 months for phase III trials. Overall physical activity, nutrition, co-prescriptions and comorbidity should be recorded. Participants in these trials should be at least 70-years-old and present with a combination of low muscle strength and low physical performance. Severely malnourished individuals, as well as bedridden patients, patients with extremely limited mobility or individuals with physical limitations clearly attributable to the direct effect of a specific disease, should be excluded. Multiple outcomes are proposed for phase II trials, including, as example, physical performance, muscle strength and mass, muscle metabolism and muscle-bone interaction. For phase III trials, we recommend a co-primary endpoint of a measure of functional performance and a Patient Reported Outcome Measure. CONCLUSION: The working group has formulated consensus recommendations on specific aspects of trial design, and in doing so hopes to contribute to an improvement of the methodological robustness and comparability of clinical trials. Standardization of designs and outcomes would advance the field by allowing better comparison across studies, including performing individual patient-data meta-analyses, and different pro-myogenic therapies.
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spelling pubmed-78976192021-03-05 Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults Reginster, Jean-Yves Beaudart, Charlotte Al-Daghri, Nasser Avouac, Bernard Bauer, Jürgen Bere, Nathalie Bruyère, Olivier Cerreta, Francesca Cesari, Matteo Rosa, Mario Miguel Cooper, Cyrus Cruz Jentoft, Alfonso J. Dennison, Elaine Geerinck, Anton Gielen, Evelien Landi, Francesco Laslop, Andrea Maggi, Stefania Prieto Yerro, María Concepción Rizzoli, René Sundseth, Hildrun Sieber, Cornel Trombetti, Andrea Vellas, Bruno Veronese, Nicola Visser, Marjolein Vlaskovska, Mila Fielding, Roger A. Aging Clin Exp Res Review BACKGROUND: In 2016, an expert working group was convened under the auspices of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and formulated consensus recommendations for the conduct of clinical trials for drugs to prevent or treat sarcopenia. AIMS: The objective of the current paper is to provide a 2020 update of the previous recommendations in accordance with the evidence that has become available since our original recommendations. METHODS: This paper is based on literature reviews performed by members of the ESCEO working group and followed up with face to face meetings organized for the whole group to make amendments and discuss further recommendations. RESULTS: The randomized placebo-controlled double-blind parallel-arm drug clinical trials should be the design of choice for both phase II and III trials. Treatment and follow-up should run at least 6 months for phase II and 12 months for phase III trials. Overall physical activity, nutrition, co-prescriptions and comorbidity should be recorded. Participants in these trials should be at least 70-years-old and present with a combination of low muscle strength and low physical performance. Severely malnourished individuals, as well as bedridden patients, patients with extremely limited mobility or individuals with physical limitations clearly attributable to the direct effect of a specific disease, should be excluded. Multiple outcomes are proposed for phase II trials, including, as example, physical performance, muscle strength and mass, muscle metabolism and muscle-bone interaction. For phase III trials, we recommend a co-primary endpoint of a measure of functional performance and a Patient Reported Outcome Measure. CONCLUSION: The working group has formulated consensus recommendations on specific aspects of trial design, and in doing so hopes to contribute to an improvement of the methodological robustness and comparability of clinical trials. Standardization of designs and outcomes would advance the field by allowing better comparison across studies, including performing individual patient-data meta-analyses, and different pro-myogenic therapies. Springer International Publishing 2020-07-31 2021 /pmc/articles/PMC7897619/ /pubmed/32737844 http://dx.doi.org/10.1007/s40520-020-01663-4 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Review
Reginster, Jean-Yves
Beaudart, Charlotte
Al-Daghri, Nasser
Avouac, Bernard
Bauer, Jürgen
Bere, Nathalie
Bruyère, Olivier
Cerreta, Francesca
Cesari, Matteo
Rosa, Mario Miguel
Cooper, Cyrus
Cruz Jentoft, Alfonso J.
Dennison, Elaine
Geerinck, Anton
Gielen, Evelien
Landi, Francesco
Laslop, Andrea
Maggi, Stefania
Prieto Yerro, María Concepción
Rizzoli, René
Sundseth, Hildrun
Sieber, Cornel
Trombetti, Andrea
Vellas, Bruno
Veronese, Nicola
Visser, Marjolein
Vlaskovska, Mila
Fielding, Roger A.
Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults
title Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults
title_full Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults
title_fullStr Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults
title_full_unstemmed Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults
title_short Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults
title_sort update on the esceo recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7897619/
https://www.ncbi.nlm.nih.gov/pubmed/32737844
http://dx.doi.org/10.1007/s40520-020-01663-4
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