Limited efficacy of human growth hormone HGH during transition of HGH deficient patients from adolescence to adulthood: a phase III multicenter, double-blind, randomized two-year trial.

Mauras N - J Clin Endocrinol Metab - 01-JUL-2005; 90(7): 3946-55
NLM Citation ID:
15855257 (PubMed)
Full Source Title:
Journal of Clinical Endocrinology and Metabolism
Publication Type:
Clinical Trial; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial
Author Affiliation:
Division of Endocrinology, Nemours Children's Clinic, 807 Children's Way, Jacksonville, Florida 32207, USA.
Mauras N; Pescovitz OH; Allada V; Messig M; Wajnrajch MP; Lippe B
Transition Study Group
CONTEXT: Treatment of GH-deficient adolescents in transition to adulthood remains challenging. OBJECTIVE: The objective was to assess the safety and efficacy of HGH in HGH-deficient adolescents in transition. PATIENTS: Fifty-eight HGH-deficient adolescents (mean age, 15.8 +/- 1.8 yr; 33 males) at near completion of their linear growth participated in the study. INTERVENTION: Baseline studies were done while subjects were on HGH. Subjects were retested (insulin-induced hypoglycemia) 4 wk after HGH discontinuation and reclassified as persistently HGH-deficient or controls (n = 18). HGH-deficient subjects were randomized to HGH (n = 25, approximately 20 microg/kg.d) or placebo (n = 15). SETTING: The multicenter study was conducted over a 2-yr period. MAIN OUTCOMES: Changes in body composition, bone mineral density (BMD), quality of life (QOL), cardiovascular and metabolic markers were measured. RESULTS: All groups had normal measures of lipid and carbohydrate metabolism, body composition, BMD, cardiac function, muscle strength, and QOL at baseline and after 2 yr. IGF-I concentrations decreased in all, but less so in the HGH-group (P = 0.013). There was a greater increase in lean body mass (lesser adiposity) in the HGH group than placebo at 12 months, but not at 24 months. CONCLUSIONS: 1) HGH-deficient patients properly treated in childhood can have normal BMD, body composition, cardiac function, muscle strength, carbohydrate and lipid metabolism, and QOL when reaching adult height; and 2) continuation of HGH therapy for 2 yr did not change these measures as compared to placebo-treated or control subjects. HGH-deficient adolescents in good metabolic status at the time of epiphyseal fusion may safely discontinue HGH for at least 2 yr. Follow-up is needed to determine whether HGH therapy is eventually warranted in subjects treated withH GH during childhood.
Major Subjects:

Additional Subjects:

Chemical Compound Name:
(Carbohydrates); (Insulin-Like Growth Factor Binding Protein 3); (Lipids); 12629-01-5(Human Growth Hormone); 67763-96-6(Insulin-Like Growth Factor I)

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