Effects of an oral growth hormone secretagogue in older adults.

Abstract

CONTEXT:

GH secretion declines with age, possibly contributing to reduced muscle mass, strength, and function. GH secretagogues (GHS) may increase muscle mass and physical performance.

OBJECTIVES/DESIGN:

We conducted a randomized, double-masked, placebo-controlled, multicenter study to investigate the hormonal, body composition, and physical performance effects and the safety of the orally active GHS capromorelin in older adults with mild functional limitation. INTERVENTION/PARTICIPANTS: A total of 395 men and women aged 65-84 yr were randomized for an intended 2 yr of treatment to four dosing groups (10 mg three times/week, 3 mg twice a day, 10 mg each night, and 10 mg twice a day) or placebo. Although the study was terminated early according to predetermined treatment effect criteria, 315 subjects completed 6 months of treatment, and 284 completed 12 months.

RESULTS:

A sustained dose-related rise in IGF-I concentrations occurred in all active treatment groups. Each capromorelin dose prompted a rise in peak nocturnal GH, which was greatest with the least frequent dosing. At 6 months, body weight increased 1.4 kg in subjects receiving capromorelin and decreased 0.2 kg in those receiving placebo (P = 0.006). Lean body mass increased 1.4 vs. 0.3 kg (P = 0.001), and tandem walk improved by 0.9 sec (P = 0.02) in the pooled treatment vs. placebo groups. By 12 months, stair climb also improved (P = 0.04). Adverse events included fatigue, insomnia, and small increases in fasting glucose, glycosylated hemoglobin, and indices of insulin resistance.

CONCLUSIONS:

In healthy older adults at risk for functional decline, administration of the oral GHS capromorelin may improve body composition and physical function.

• Authors: Heidi K White, Charles D Petrie, William Landschulz, David MacLean, Ann Taylor, Kenneth Lyles, Jeanne Y Wei, Andrew R Hoffman, Roberto Salvatori, Mark P Ettinger, Miriam C Morey, Marc R Blackman, George R Merriam, Capromorelin Study Group
• Journal: The Journal of clinical endocrinology and metabolism (J Clin Endocrinol Metab) Vol. 94 Issue 4 Pg. 1198-206 (Apr 2009) ISSN: 1945-7197 [Electronic] United States
• PMID: 19174493 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• CP 424391
• Piperidines
• Placebos
• Pyrazoles
• Human Growth Hormone
• Insulin-Like Growth Factor I

Topics

• Administration, Oral
• Aged
• Aged, 80 and over
• Body Composition (drug effects)
• Double-Blind Method
• Female
• Health Status
• Human Growth Hormone (blood, metabolism)
• Humans
• Insulin-Like Growth Factor I (metabolism)
• Male
• Piperidines (therapeutic use)
• Placebos
• Pyrazoles (therapeutic use)
• Safety