Background: The number of elderly people is growing worldwide, and a substantial proportion of them report difficulty with mobility and in performing activities of daily living. The demographic trends have created enormous interest in development of function-promoting anabolic therapies. At present, androgens and myostatin inhibitors are the two leading classes of function-promoting anabolic therapies that are the most advanced in the drug development process. However, clinical development has been slowed by vexing trial design issues.
Conclusions: Clinical investigators, regulatory agencies and the National Institutes of Health must continue working toward a consensus about the indications for study, efficacy outcomes and what differences in functional outcomes are needed to determine sample size estimates.
Copyright © 2011 S. Karger AG, Basel.