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Onset of puberty and near adult height in short children born small for gestational age and treated with GH: Interim analysis of up to 10 years of treatment in Japan
The safety and effectiveness of long-term (10-yr) GH treatment in short Japanese children born small for gestational age (SGA) were evaluated based on interim data analysis from a clinical study, including the findings concerning the influence on the onset of puberty and subjects who achieved near a...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Japanese Society for Pediatric Endocrinology
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4322289/ https://www.ncbi.nlm.nih.gov/pubmed/25678756 http://dx.doi.org/10.1297/cpe.24.15 |
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author | Tanaka, Toshiaki Yokoya, Susumu Seino, Yoshiki Tada, Hiroshi Mishina, Jun Sato, Takahiro Hiro, Shintaro Ohki, Nobuhiko |
author_facet | Tanaka, Toshiaki Yokoya, Susumu Seino, Yoshiki Tada, Hiroshi Mishina, Jun Sato, Takahiro Hiro, Shintaro Ohki, Nobuhiko |
author_sort | Tanaka, Toshiaki |
collection | PubMed |
description | The safety and effectiveness of long-term (10-yr) GH treatment in short Japanese children born small for gestational age (SGA) were evaluated based on interim data analysis from a clinical study, including the findings concerning the influence on the onset of puberty and subjects who achieved near adult height (NAH). Sixty-one subjects were analyzed at baseline in this study. Eleven subjects (6 boys and 5 girls) achieved NAH (mean 157.4 cm and 145.5 cm, respectively), and the Δ height SDS from the start of GH treatment was +1.6 in boys and +1.8 in girls. The median age (yr) at onset of puberty was 11.4 in boys and 9.9 in girls, comparable to healthy children. However, the mean height (cm) at onset of puberty (137.0 in boys; 125.5 in girls) was shorter than that of healthy children. Treatment-related adverse events were generally mild to moderate in severity; however, adenoidal hypertrophy was observed in two subjects as a serious adverse event. One subject had jaw malformation related to GH treatment at a dose of 0.067 mg/kg/d. No notable changes in HbA1c levels were observed, and the levels remained within the reference range. We have confirmed the safety and effectiveness of long-term GH treatment through this ongoing clinical study. |
format | Online Article Text |
id | pubmed-4322289 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | The Japanese Society for Pediatric Endocrinology |
record_format | MEDLINE/PubMed |
spelling | pubmed-43222892015-02-12 Onset of puberty and near adult height in short children born small for gestational age and treated with GH: Interim analysis of up to 10 years of treatment in Japan Tanaka, Toshiaki Yokoya, Susumu Seino, Yoshiki Tada, Hiroshi Mishina, Jun Sato, Takahiro Hiro, Shintaro Ohki, Nobuhiko Clin Pediatr Endocrinol Original Article The safety and effectiveness of long-term (10-yr) GH treatment in short Japanese children born small for gestational age (SGA) were evaluated based on interim data analysis from a clinical study, including the findings concerning the influence on the onset of puberty and subjects who achieved near adult height (NAH). Sixty-one subjects were analyzed at baseline in this study. Eleven subjects (6 boys and 5 girls) achieved NAH (mean 157.4 cm and 145.5 cm, respectively), and the Δ height SDS from the start of GH treatment was +1.6 in boys and +1.8 in girls. The median age (yr) at onset of puberty was 11.4 in boys and 9.9 in girls, comparable to healthy children. However, the mean height (cm) at onset of puberty (137.0 in boys; 125.5 in girls) was shorter than that of healthy children. Treatment-related adverse events were generally mild to moderate in severity; however, adenoidal hypertrophy was observed in two subjects as a serious adverse event. One subject had jaw malformation related to GH treatment at a dose of 0.067 mg/kg/d. No notable changes in HbA1c levels were observed, and the levels remained within the reference range. We have confirmed the safety and effectiveness of long-term GH treatment through this ongoing clinical study. The Japanese Society for Pediatric Endocrinology 2015-02-10 2015-01 /pmc/articles/PMC4322289/ /pubmed/25678756 http://dx.doi.org/10.1297/cpe.24.15 Text en 2015©The Japanese Society for Pediatric Endocrinology http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (by-nc-nd) License. |
spellingShingle | Original Article Tanaka, Toshiaki Yokoya, Susumu Seino, Yoshiki Tada, Hiroshi Mishina, Jun Sato, Takahiro Hiro, Shintaro Ohki, Nobuhiko Onset of puberty and near adult height in short children born small for gestational age and treated with GH: Interim analysis of up to 10 years of treatment in Japan |
title | Onset of puberty and near adult height in short children born small for
gestational age and treated with GH: Interim analysis of up to 10 years of treatment in
Japan |
title_full | Onset of puberty and near adult height in short children born small for
gestational age and treated with GH: Interim analysis of up to 10 years of treatment in
Japan |
title_fullStr | Onset of puberty and near adult height in short children born small for
gestational age and treated with GH: Interim analysis of up to 10 years of treatment in
Japan |
title_full_unstemmed | Onset of puberty and near adult height in short children born small for
gestational age and treated with GH: Interim analysis of up to 10 years of treatment in
Japan |
title_short | Onset of puberty and near adult height in short children born small for
gestational age and treated with GH: Interim analysis of up to 10 years of treatment in
Japan |
title_sort | onset of puberty and near adult height in short children born small for
gestational age and treated with gh: interim analysis of up to 10 years of treatment in
japan |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4322289/ https://www.ncbi.nlm.nih.gov/pubmed/25678756 http://dx.doi.org/10.1297/cpe.24.15 |
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