GH production rates markedly increase during human puberty, mostly as an amplitude-modulated phenomenon. However, pubertal GH-deficient children have been dosed on a standard per kg body weight basis similarly to prepubertal children. This study was designed to compare the efficacy and safety of conventional (Group I (GI), 0.3 mg/kg.w) vs high dose rhGH Rx (Group II (GII), 0.7 mg/kg.w), in GH-deficient adolescents treated with rhGH for at least 6 mo. 97 children with evidence of GH deficiency (poor linear growth, peak GH to stimuli < 10 μg/L, organic and idiopathic), were recruited. The groups were matched for sex (I:42M, 7F; II: 41M, 7F), age (I: 14.0±1.6 (SD) yrs; II: 13.7±1.6), height SDS (I: -1.4±1.1; II:-1.2±1.1), bone age (BA) (I: 13.2±1.3 yrs; II: 13.1±1.3) and etiology, maximum stimulated GH, previous growth rate and mid-parental target height (Ht). All were in puberty (mean: Tanner Stage 3). Differences from baseline (Δ) were available at 12, 24 and 30 mo. The Δ growth velocity (cm/y) at 12 mo: -0.3±2.5 (I), +1.3±2.8 (II), p=0.005; at 30 mo: -3.8±2.9 (I),-2.0±3.4 (II), p=0.07; Δ Ht (cm): 12 mo: 8.2±2.3 (I), 9.9±2.1 (II), p=0.0004; 30 mo: 18.6±4.7 (I), 21.8±4.8 (II), p=0.02; Δ Bailey-Pinneau predicted Ht (cm): 12 mo: 1.1±4.6 (I), 3.3±4.9 (II), p=0.03; 30 mo: 4.4±5.4 (I), 7.7±6.8 (II), p=0.17. Δ IGF-I: 12 mo: 131±238 μg/L (I), 175±317 (II), p=0.89; 30 mo: 257±255(I), 329±411 (II), p=0.92. No differences in Δ BA were detected between groups at any interval: 30 mo: 2.6±1.2 (I), 2.6±1.1(II), p=0.94. In boys treated ≥2 yrs, the Δ Ht was 4cm greater in the high-dose group. High dose rhGH was well tolerated with no difference in HbA1c or glucose concentrations between groups. Plasma insulin concentrations were higher in GII (p=0.01). In summary: Preliminary analysis shows that as compared to conventional treatment, high dose rhGH Rx in adolescents: 1-increased Ht and Ht SDS scores significantly; 2-did not advance skeletal maturation; 3-appeared to be well tolerated and safe. We conclude: High dose rhGH Rx improves the final adult Ht gain in GH-deficient patients in puberty, without increasing the rate of bone maturation.
Author information
Authors and Affiliations
Consortia
Additional information
This study was funded by Genentech, Inc.
Rights and permissions
About this article
Cite this article
Mauras, N., Reiter, E., Baptista, J. et al. Effects of High Dose rhGH Therapy in Adolescent Children with GH Deficiency: A Randomized, Multicenter Study • 460. Pediatr Res 43 (Suppl 4), 81 (1998). https://doi.org/10.1203/00006450-199804001-00481
Issue Date:
DOI: https://doi.org/10.1203/00006450-199804001-00481