Phase 3 trials estimate the effectiveness of an intervention to prevent, delay the onset of, or treat sarcopenia. Participants should have sarcopenia or present a sarcopenia risk profile. Control group should be characterized by the best standard of clinical care. This article further develops issues on sarcopenia definition, target population, primary and secondary end points, duration of the trials, muscle mass assessment, strength and physical performance assessment, and control of possible confounders. The challenges to conduct phase 3 trials in the elderly should not offset the opportunities for the development of new strategies to counteract sarcopenia and prevent late-life disability.
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