The journal of nutrition, health & aging

, Volume 17, Issue 7, pp 612–618 | Cite as

Designing pharmaceutical trials for sarcopenia in frail older adults: EU/US task force recommendations

  • B. Vellas
  • M. Pahor
  • T. Manini
  • D. Rooks
  • J. M. Guralnik
  • J. Morley
  • S. Studenski
  • W. Evans
  • C. Asbrand
  • R. Fariello
  • S. Pereira
  • Y. Rolland
  • G. Abellan Van Kan
  • M. Cesari
  • W. M. C. Chumlea
  • R. Fielding
Article

Abstract

An international task force of academic and industry leaders in sarcopenia research met on December 5, 2012 in Orlando, Florida to develop guidelines for designing and executing randomized clinical trials of sarcopenia treatments. The Task Force reviewed results from previous trials in related disease areas to extract lessons relevant to future sarcopenia trials, including practical issues regarding the design and conduct of trials in elderly populations, the definition of appropriate target populations, and the selection of screening tools, outcome measures, and biomarkers. They discussed regulatory issues, the challenges posed by trials of different types of interventions, and the need for standardization and harmonization. The Task Force concluded with recommendations for advancing the field toward better clinical trials.

Key words

Sarcopenia clinical trial skeletal muscle frailty intervention 

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Copyright information

© Serdi and Springer-Verlag France 2013

Authors and Affiliations

  • B. Vellas
    • 1
    • 2
    • 3
  • M. Pahor
    • 4
  • T. Manini
    • 4
  • D. Rooks
    • 5
  • J. M. Guralnik
    • 6
  • J. Morley
    • 7
  • S. Studenski
    • 8
  • W. Evans
    • 9
  • C. Asbrand
    • 10
  • R. Fariello
    • 11
  • S. Pereira
    • 12
  • Y. Rolland
    • 1
    • 2
    • 3
  • G. Abellan Van Kan
    • 3
  • M. Cesari
    • 1
    • 2
    • 3
  • W. M. C. Chumlea
    • 13
  • R. Fielding
    • 14
  1. 1.Inserm UMR1027 InsermToulouseFrance
  2. 2.University of Toulouse IIIToulouseFrance
  3. 3.GerontopoleToulouse University HospitalToulouseFrance
  4. 4.University of FloridaGainesvilleUSA
  5. 5.Novartis Institutes for Biomedical ResearchCambridgeUSA
  6. 6.University of Maryland School of MedicineBaltimoreUSA
  7. 7.St. Louis University Medical SchoolSt. LouisUSA
  8. 8.University of PittsburghPittsburghUSA
  9. 9.GlaxoSmithKlineDurhamUSA
  10. 10.Sanofi-Aventis Deutschland GmbHFrankfurtGermany
  11. 11.Neurotune AGSchlierenSwitzerland
  12. 12.Abbott Nutrition R&DColumbusUSA
  13. 13.Lifespan Health Research Center, Boonshoft School of MedicineWright State UniversityDaytonUSA
  14. 14.Jean Mayer USDA Human Nutrition Research Center on AgingTufts UniversityBostonUSA

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