ArticleClinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology2020
The long-term safety and effectiveness of growth hormone treatment in Japanese children with short stature born small for gestational age.
Article in Clinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01110928 (A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Patients With SGA Short Stature Without Closure of Epiphyseal Discs), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Patients With SGA Short Stature Without Closure of Epiphyseal Discs
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.
- Effects of long-term treatment with recombinant growth hormone on growth outcome in children born small for gestational age: a systematic review.Reviews in endocrine & metabolic disorders · 2025Pooled it
- International Consensus Guideline on Small for Gestational Age: Etiology and Management From Infancy to Early Adulthood.Endocrine reviews · 2023Guideline
- Diagnosis and management of Silver-Russell syndrome: second international consensus statement.Nature reviews. Endocrinology · 2026Review
- Long-Term experience with growth hormone therapy in pediatric growth disorders: an analysis of the LG growth study data.Endocrine · 2026Observational
- Exploratory secondary analysis of published aggregate growth and metabolic data in children born small for gestational age treated with growth hormone.Frontiers in endocrinology · 2026Review
- Determinants of adverse event occurrence in children with short stature born small for gestational age treated with growth hormone.Frontiers in endocrinology · 2025Observational
- GH Therapy in Non-Growth Hormone-Deficient Children.Children (Basel, Switzerland) · 2024Review
- Health-related Quality of Life and Problem Behavior After GH Cessation in Adults Born Small for Gestational Age: A 12-Year Follow-up Study.The Journal of clinical endocrinology and metabolism · 2024Article
- Article
- Growth Hormone Treatment for Non-GHD Disorders: Excitement Tempered by Biology.The Journal of clinical endocrinology and metabolism · 2024Review
- Long-Term Efficacy and Safety of Recombinant Human Growth Hormone in Children Born Small for Gestational Age.Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme · 2023Article
- Growth Hormone Dose Modulation and Final Height in Short Children Born Small for Gestational Age: French Real-Life Data.Hormone research in paediatrics · 2023Observational
- [Short stature due to intrauterine growth retardation. Clinical and hormonal-metabolic features, possibilities of growth-stimulating therapy].Problemy endokrinologii · 2022Article
- Response to Treatment with Recombinant Human Growth Hormone (rhGH) of Short Stature Children Born Too Small for Gestational Age (SGA) in Selected Centres in Poland.Journal of clinical medicine · 2022Article
- Long-term effectiveness of growth hormone therapy in children born small for gestational age: An analysis of LG growth study data.PloS one · 2022Article
- Various phenotypes of short stature with heterozygousClinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology · 2022Article
- Effectiveness of a smartphone application on medication adherence in children with short stature receiving GH therapy: A multicenter prospective cohort study (GTL-App).Clinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This study aimed to characterize the safety and effectiveness of GH treatments, in usual clinical practice, in children with short stature born small for gestational age (SGA). This was a multicenter, open-label, non-interventional study (NCT01110928) conducted at 150 sites in Japan (2009-2018). The primary objective was to assess the type and frequency of serious adverse drug reactions (SADRs) associated with long-term GH use. Overall, 452 naïve and 46 non-naïve (previously treated) children were enrolled. GH treatment was well‑tolerated, with SADRs occurring in 1.3% (6/452) and 0% (0/46) of naïve and non-naïve children, respectively. No new safety concerns or notable changes in glucose metabolism were identified during long-term treatment. Altogether, 57 children (32 naïve and 25 non-naïve) reached near adult height (NAH). In naïve and non-naïve children, mean ± standard deviation (SD) height standard deviation score (SDS) at NAH were -2.03 ± 0.77 and -1.53 ± 0.81, respectively, representing a change of +0.85 ± 0.72 and +1.24 ± 0.66 from baseline height SDS, respectively. Mean treatment duration to NAH was 4.29 (naïve) and 7.26 (non-naïve) yr. Thus, long-term GH treatment for short stature in children born SGA was confirmed to have a good safety profile and was effective for improving adult height.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.