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Dose-Dependent Effect of Growth Hormone on Final Height in Children with Short Stature without Growth Hormone Deficiency

Göteborg Pediatric Growth Research Center (K.A.-W., B.K., O.W.), Department of Pediatrics, Institute of Clinical Sciences, The Sahlgrenska Academy at University of Gothenburg, SE-41685 Gothenburg, Sweden; Department of Pediatrics (A.S.A.), The Central County Hospital of Halmstad, SE-30185 Halmstad, Sweden; Department of Women’s and Children’s Health (J.G., B.J., T.T.), Uppsala University, SE-75185 Uppsala, Sweden; Department of Woman and Child Health (L.H., E.M.R.), Karolinska Institutet, SE-17176 Stockholm, Sweden; Department of Clinical Sciences (S.A.I., K.O.N.), University Hospital Malmö, Lund University, SE-20502 Malmö, Sweden; Department of Clinical Science, Paediatrics (B.K.), Umeå University, SE-90185 Umeå, Sweden; Division of Pediatrics (C.M.), Department for Clinical Science, Intervention and Technology, Karolinska Institutet, SE-14186 Stockholm, Sweden; and Department of Pediatrics (J.A.), Örebro University, SE-70185 Örebro, Sweden

Address all correspondence and requests for reprints to: Kerstin Albertsson-Wikland, Göteborg Pediatric Growth Research Center/Växthuset, The Queen Silvia Children’s Hospital, SE-416 85 Göteborg, Sweden. E-mail: kerstin.albertsson-wikland{at}pediat.gu.se.

Context: The effect of GH therapy in short non-GH-deficient children, especially those with idiopathic short stature (ISS), has not been clearly established owing to the lack of controlled trials continuing until final height (FH).

Objective: The aim of the study was to investigate the effect on growth to FH of two GH doses given to short children, mainly with ISS, compared with untreated controls.

Design and Setting: A randomized, controlled, long-term multicenter trial was conducted in Sweden.

Intervention: Two doses of GH (Genotropin) were administered, 33 or 67 µg/kg·d; control subjects were untreated.

Subjects: A total of 177 subjects with short stature were enrolled. Of these, 151 were included in the intent to treat (All_ITT) population, and 108 in the per protocol (All_PP) population. Analysis of ISS subjects included 126 children in the ITT (ISS_ITT) population and 68 subjects in the PP (ISS_PP) population.

Main Outcome Measures: We measured FH SD score (SDS), difference in SDS to midparenteral height (diff MPH_SDS), and gain in height_SDS.

Results: After 5.9 ± 1.1 yr on GH therapy, the FH_SDS in the All_PP population treated with GH vs. controls was –1.5 ± 0.81 (33 µg/kg·d, –1.7 ± 0.70; and 67 µg/kg·d, –1.4 ± 0.86; P < 0.032), vs. –2.4 ± 0.85 (P < 0.001); the diff MPH_SDS was –0.2 ± 1.0 vs. –1.0 ± 0.74 (P < 0.001); and the gain in height_SDS was 1.3 ± 0.78 vs. 0.2 ± 0.69 (P < 0.001). GH therapy was safe and had no impact on time to onset of puberty. A dose-response relationship identified after 1 yr remained to FH for all growth outcome variables in all four populations.

Conclusion: GH treatment significantly increased FH in ISS children in a dose-dependent manner, with a mean gain of 1.3 SDS (8 cm) and a broad range of response from no gain to 3 SDS compared to a mean gain of 0.2 SDS in the untreated controls.

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