CONTEXT: Treatment of GH-deficient adolescents in transition to adulthood remains challenging. OBJECTIVE: The objective was to assess the safety and efficacy of GH in GH-deficient adolescents in transition. PATIENTS: Fifty-eight GH-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 GH. Subjects were retested (insulin-induced hypoglycemia) 4 wk after GH discontinuation and reclassified as persistently GH-deficient or controls (n = 18). GH-deficient subjects were randomized to GH (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 GH-group (P = 0.013). There was a greater increase in lean body mass (lesser adiposity) in the GH group than placebo at 12 months, but not at 24 months. CONCLUSIONS: 1) GH-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 GH therapy for 2 yr did not change these measures as compared to placebo-treated or control subjects. GH-deficient adolescents in good metabolic status at the time of epiphyseal fusion may safely discontinue GH for at least 2 yr. Follow-up is needed to determine whether GH therapy is eventually warranted in subjects treated with GH during childhood.
RCT Entities:
CONTEXT: Treatment of GH-deficient adolescents in transition to adulthood remains challenging. OBJECTIVE: The objective was to assess the safety and efficacy of GH in GH-deficient adolescents in transition. PATIENTS: Fifty-eight GH-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 GH. Subjects were retested (insulin-induced hypoglycemia) 4 wk after GH discontinuation and reclassified as persistently GH-deficient or controls (n = 18). GH-deficient subjects were randomized to GH (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 GH-group (P = 0.013). There was a greater increase in lean body mass (lesser adiposity) in the GH group than placebo at 12 months, but not at 24 months. CONCLUSIONS: 1) GH-deficientpatients 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 GH therapy for 2 yr did not change these measures as compared to placebo-treated or control subjects. GH-deficient adolescents in good metabolic status at the time of epiphyseal fusion may safely discontinue GH for at least 2 yr. Follow-up is needed to determine whether GH therapy is eventually warranted in subjects treated with GH during childhood.
Authors: G Aimaretti; R Attanasio; S Cannavò; M C Nicoletti; R Castello; C Di Somma; P Garofalo; L Iughetti; S Loche; M Maghnie; L Mazzanti; G Saggese; M Salerno; G Tonini; V Toscano; S Zucchini; M Cappa Journal: J Endocrinol Invest Date: 2014-11-02 Impact factor: 4.256
Authors: Laurie E Cohen; Joshua H Gordon; Erica Y Popovsky; Nina N Sainath; Henry A Feldman; Mark W Kieran; Catherine M Gordon Journal: Pediatr Blood Cancer Date: 2011-08-29 Impact factor: 3.167
Authors: Nicholas A Tritos; Amir H Hamrahian; Donna King; Susan L Greenspan; David M Cook; Peter J Jönsson; Michael P Wajnrajch; Maria Koltowska-Häggstrom; Beverly M K Biller Journal: Eur J Endocrinol Date: 2012-06-18 Impact factor: 6.664