Effects of an oral growth hormone secretagogue in older adults

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

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1198-1206
Number of pages9
JournalJournal of Clinical Endocrinology and Metabolism
Volume94
Issue number4
DOIs
StatePublished - Apr 2009

Fingerprint

Growth Hormone
Placebos
Muscle
Body Composition
Stairs
Glycosylated Hemoglobin A
Therapeutics
Chemical analysis
Insulin-Like Growth Factor I
Sleep Initiation and Maintenance Disorders
Muscle Strength
Multicenter Studies
Fatigue of materials
Fatigue
Oral Administration
Insulin Resistance
Insulin
Fasting
Glucose
Body Weight

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Endocrinology
  • Biochemistry, medical
  • Endocrinology, Diabetes and Metabolism

Cite this

White, H. K., Petrie, C. D., Landschulz, W., MacLean, D., Taylor, A., Lyles, K., ... Merriam, G. R. (2009). Effects of an oral growth hormone secretagogue in older adults. Journal of Clinical Endocrinology and Metabolism, 94(4), 1198-1206. https://doi.org/10.1210/jc.2008-0632

Effects of an oral growth hormone secretagogue in older adults. / White, Heidi K.; Petrie, Charles D.; Landschulz, William; MacLean, David; Taylor, Ann; Lyles, Kenneth; Wei, Jeanne Y.; Hoffman, Andrew R.; Salvatori, Roberto; Ettinger, Mark P.; Morey, Miriam C.; Blackman, Marc R.; Merriam, George R.

In: Journal of Clinical Endocrinology and Metabolism, Vol. 94, No. 4, 04.2009, p. 1198-1206.

Research output: Contribution to journalArticle

White, HK, Petrie, CD, Landschulz, W, MacLean, D, Taylor, A, Lyles, K, Wei, JY, Hoffman, AR, Salvatori, R, Ettinger, MP, Morey, MC, Blackman, MR & Merriam, GR 2009, 'Effects of an oral growth hormone secretagogue in older adults', Journal of Clinical Endocrinology and Metabolism, vol. 94, no. 4, pp. 1198-1206. https://doi.org/10.1210/jc.2008-0632
White HK, Petrie CD, Landschulz W, MacLean D, Taylor A, Lyles K et al. Effects of an oral growth hormone secretagogue in older adults. Journal of Clinical Endocrinology and Metabolism. 2009 Apr;94(4):1198-1206. https://doi.org/10.1210/jc.2008-0632
White, Heidi K. ; Petrie, Charles D. ; Landschulz, William ; MacLean, David ; Taylor, Ann ; Lyles, Kenneth ; Wei, Jeanne Y. ; Hoffman, Andrew R. ; Salvatori, Roberto ; Ettinger, Mark P. ; Morey, Miriam C. ; Blackman, Marc R. ; Merriam, George R. / Effects of an oral growth hormone secretagogue in older adults. In: Journal of Clinical Endocrinology and Metabolism. 2009 ; Vol. 94, No. 4. pp. 1198-1206.
@article{536f705f4a4a4cfcb32c7e24a2cf9fb1,
title = "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.",
author = "White, {Heidi K.} and Petrie, {Charles D.} and William Landschulz and David MacLean and Ann Taylor and Kenneth Lyles and Wei, {Jeanne Y.} and Hoffman, {Andrew R.} and Roberto Salvatori and Ettinger, {Mark P.} and Morey, {Miriam C.} and Blackman, {Marc R.} and Merriam, {George R.}",
year = "2009",
month = "4",
doi = "10.1210/jc.2008-0632",
language = "English (US)",
volume = "94",
pages = "1198--1206",
journal = "Journal of Clinical Endocrinology and Metabolism",
issn = "0021-972X",
publisher = "The Endocrine Society",
number = "4",

}

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.

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

VL - 94

SP - 1198

EP - 1206

JO - Journal of Clinical Endocrinology and Metabolism

JF - Journal of Clinical Endocrinology and Metabolism

SN - 0021-972X

IS - 4

ER -