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

Albertsson-Wikland, Kerstin; Aronson, A Stefan; Gustafsson, Jan; Hagenäs, Lars; Ivarsson, Sten A; Jonsson, Björn; Kriström, Berit; Marcus, Claude; Nilsson, Karl-Olof LU and Ritzén, E Martin, et al. (2008) In Journal of Clinical Endocrinology and Metabolism 93. p.4342-4350
Abstract
Context: Effect of GH therapy in short non GH deficient children, especially idiopathic short stature (ISS) has not been clearly established owing to lack of controlled trials until final height (FH). Objective: To investigate the effect of two GH doses compared with untreated controls on growth to FH in short children mainly with ISS. Design and Setting: A randomized, controlled, long-term multicenter trial in Sweden. Intervention: Two doses of GH (Genotropin): 33 or 67 microg/kg/d plus untreated controls. Subjects: 177 subjects with short stature were enrolled. Of these, 151 were included in the Intent to Treat (AllITT) Population and 108 in the Per Protocol (AllPP) Population. Analysis of ISS subjects included 126 children in the ITT... (More)
Context: Effect of GH therapy in short non GH deficient children, especially idiopathic short stature (ISS) has not been clearly established owing to lack of controlled trials until final height (FH). Objective: To investigate the effect of two GH doses compared with untreated controls on growth to FH in short children mainly with ISS. Design and Setting: A randomized, controlled, long-term multicenter trial in Sweden. Intervention: Two doses of GH (Genotropin): 33 or 67 microg/kg/d plus untreated controls. Subjects: 177 subjects with short stature were enrolled. Of these, 151 were included in the Intent to Treat (AllITT) Population and 108 in the Per Protocol (AllPP) Population. Analysis of ISS subjects included 126 children in the ITT (ISSITT) Population and 68 subjects in the PP (ISSPP) Population. Main Outcome Measures: FH SDS, difference in SDS to midparenteral height (diff MPHSDS), and gain in HeightSDS. Results: After 5.9+/-1.1 yr on GH therapy, the FHSDS in the AllPP Population treated with GH vs. controls was -1.5+/-0.81 (33 microg/kg/d: -1.7+/-0.70, 67 microg/kg/d: -1.4+/-0.86; P<0.032), vs. -2.4+/-0.85 (P<0.001), the diff MPHSDS -0.2+/-1.0 vs. -1.0+/-0.74 (P<0.001), and the gain in HeightSDS 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. (Less)
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Journal of Clinical Endocrinology and Metabolism
volume
93
pages
4342 - 4350
publisher
The Endocrine Society
external identifiers
  • wos:000260661900025
  • pmid:18728172
  • scopus:57349180874
ISSN
1945-7197
DOI
10.1210/jc.2008-0707
language
English
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yes
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000ec92a-a0ba-49f9-8eab-afb5271ec9ab (old id 1222905)
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http://www.ncbi.nlm.nih.gov/pubmed/18728172?dopt=Abstract
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2008-09-03 12:47:26
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2017-05-28 04:38:21
@article{000ec92a-a0ba-49f9-8eab-afb5271ec9ab,
  abstract     = {Context: Effect of GH therapy in short non GH deficient children, especially idiopathic short stature (ISS) has not been clearly established owing to lack of controlled trials until final height (FH). Objective: To investigate the effect of two GH doses compared with untreated controls on growth to FH in short children mainly with ISS. Design and Setting: A randomized, controlled, long-term multicenter trial in Sweden. Intervention: Two doses of GH (Genotropin): 33 or 67 microg/kg/d plus untreated controls. Subjects: 177 subjects with short stature were enrolled. Of these, 151 were included in the Intent to Treat (AllITT) Population and 108 in the Per Protocol (AllPP) Population. Analysis of ISS subjects included 126 children in the ITT (ISSITT) Population and 68 subjects in the PP (ISSPP) Population. Main Outcome Measures: FH SDS, difference in SDS to midparenteral height (diff MPHSDS), and gain in HeightSDS. Results: After 5.9+/-1.1 yr on GH therapy, the FHSDS in the AllPP Population treated with GH vs. controls was -1.5+/-0.81 (33 microg/kg/d: -1.7+/-0.70, 67 microg/kg/d: -1.4+/-0.86; P&lt;0.032), vs. -2.4+/-0.85 (P&lt;0.001), the diff MPHSDS -0.2+/-1.0 vs. -1.0+/-0.74 (P&lt;0.001), and the gain in HeightSDS 1.3+/-0.78 vs. 0.2+/-0.69 (P&lt;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.},
  author       = {Albertsson-Wikland, Kerstin and Aronson, A Stefan and Gustafsson, Jan and Hagenäs, Lars and Ivarsson, Sten A and Jonsson, Björn and Kriström, Berit and Marcus, Claude and Nilsson, Karl-Olof and Ritzén, E Martin and Tuvemo, Torsten and Westphal, Otto and Aman, Jan},
  issn         = {1945-7197},
  language     = {eng},
  pages        = {4342--4350},
  publisher    = {The Endocrine Society},
  series       = {Journal of Clinical Endocrinology and Metabolism},
  title        = {Dose-Dependent Effect of Growth Hormone on Final Height in Children with Short Stature without Growth Hormone deficiency.},
  url          = {http://dx.doi.org/10.1210/jc.2008-0707},
  volume       = {93},
  year         = {2008},
}