TY - JOUR
T1 - Effects of an oral growth hormone secretagogue in older adults
AU - White, Heidi K.
AU - Petrie, Charles D.
AU - Landschulz, William
AU - MacLean, David
AU - Taylor, Ann
AU - Lyles, Kenneth
AU - Wei, Jeanne Y.
AU - Hoffman, Andrew R.
AU - Salvatori, Roberto
AU - Ettinger, Mark P.
AU - Morey, Miriam C.
AU - Blackman, Marc R.
AU - Merriam, George R.
N1 - Funding Information:
This study was supported by Pfizer Global Research Development, which discovered and developed capromorelin, and by the Veterans Health Administration.
Funding Information:
Disclosure Summary: C.D.P. is employed by Pfizer and holds stock in the company. W.L., D.M., and A.T. were employed by Pfizer during this research study. H.K.W., K.L., J.Y.W., A.R.H., R.S., M.P.E., M.C.M., M.R.B., and G.R.M. received grant support for this research study from Pfizer, Inc. (October 1, 1999 to December 31, 2001).
Funding Information:
We thank Maria Fiatarone-Singh, Ph.D., who was instrumental in the planning of study entry criteria and physical performance endpoints developed in phase IIa studies that preceded this reported investigation. Other members of the Capromorelin Study Group were: Drs. William Hall, Robert Lang, Marco Pahor, William Pettit, Sherwyn L. Schwartz, Stuart Weiss, and Barbara Troupin. Clinical trial training support was provided by Kolette Fly, Al Kraska, and Nikos Kolivodiakos from Pfizer Global Research & Development. Statistical analysis and programming support was provided by Robert D. Chew, Ph.D., Chitra Lele, Shirsendu Sarkar, Urszula Masiukiewicz, and Andrea Flower from Pfizer Global Research & Development. The Duke Clinical Research Institute provided supervision and monitoring of five of the 12 research sites. We thank Colleen Carney, Ann Hill, Monica Kletke, Sheila Cole, and members of the Lake Worth, Florida, Radiant Research site for excellent support in the conduct of this protocol. We also gratefully acknowledge the contributions of the late Elizabeth C. Clipp, Ph.D., of Duke University.
PY - 2009/4
Y1 - 2009/4
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=65249108287&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=65249108287&partnerID=8YFLogxK
U2 - 10.1210/jc.2008-0632
DO - 10.1210/jc.2008-0632
M3 - Article
C2 - 19174493
AN - SCOPUS:65249108287
SN - 0021-972X
VL - 94
SP - 1198
EP - 1206
JO - Journal of Clinical Endocrinology and Metabolism
JF - Journal of Clinical Endocrinology and Metabolism
IS - 4
ER -