Observational studyThe Journal of clinical endocrinology and metabolism2019
Safety Outcomes During Pediatric GH Therapy: Final Results From the Prospective GeNeSIS Observational Program.
Observational study in The Journal of clinical endocrinology and metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 76 citations in OpenAlex.
- Charting the growth of idiopathic short stature research: a 32-year bibliometric study of global advances.Frontiers in endocrinology · 2025Pooled it
- Clinical practice guidelines for the care of girls and women with Turner syndrome.European journal of endocrinology · 2024Guideline
- Somapacitan in Children Born SGA: 52-Week Efficacy, Safety, and IGF-I Response Results From the Phase 2 REAL5 Study.The Journal of clinical endocrinology and metabolism · 2025Trial
- Growth Hormone Therapy in Children Born Small for Gestational Age with Persistent Short Stature: Lessons Learned from Real-World International Databases and Directions for Future Research.Hormone research in paediatrics · 2026Review
- Accumulated safety data of recombinant human growth hormone therapy in Korean children over a 10-year period: interim results from the LG Growth Study.Endocrine connections · 2026Article
- Effectiveness and Safety of Hormonal Treatments in Children with Growth Disorders: A Systematic Review of Clinical Evidence.Clinics and practice · 2026Review
- Three decades of recombinant human growth hormone research in children born small for gestational age: a bibliometric analysis (1996-2025).Frontiers in pediatrics · 2026Article
- Capsaicin diet drives gut inflammation and exosomal miR-17-3p elevation in idiopathic short stature.Nature communications · 2025Article
- Better growth outcomes in GH-deficient children treated younger than 2 years of age.Endocrine connections · 2025Article
- Recombinant human growth hormone and brain neoplasm association: a pharmacovigilance and Mendelian randomization analysis based on US FAERS, Japanese JADER, and Canadian CVARD.Frontiers in pharmacology · 2025Article
- Insights into the ANKRD11 variants and short-stature phenotype through literature review and ClinVar database search.Orphanet journal of rare diseases · 2024Review
- [Safety considerations for the clinical application of recombinant human growth hormone].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2024Review
- Growth Hormone Treatment for Non-GHD Disorders: Excitement Tempered by Biology.The Journal of clinical endocrinology and metabolism · 2024Review
- Case report: Epilepsy during the use of recombinant human growth hormone: a report on two cases and a literature review.Frontiers in pharmacology · 2024Article
- Long-term risk of neoplastic events after childhood growth hormone treatment: a population-based cohort study in Sweden.Frontiers in endocrinology · 2024Article
- Safety and Effectiveness of a Biosimilar Recombinant Human Growth Hormone in Children Requiring Growth Hormone Treatment: Analysis of Final Data from PATRO Children, an International, Post-Marketing Surveillance Study.Drug design, development and therapy · 2024Article
- Early GH Treatment Is Effective and Well Tolerated in Children With Turner Syndrome: NordiNet® IOS and Answer Program.The Journal of clinical endocrinology and metabolism · 2023Article
- Early Growth Hormone Initiation Leads to Favorable Long-Term Growth Outcomes in Children Born Small for Gestational Age.The Journal of clinical endocrinology and metabolism · 2023Article
- Factors Associated With Response to Growth Hormone in Pediatric Growth Disorders: Results of a 5-year Registry Analysis.Journal of the Endocrine Society · 2023Article
- Growth hormone and gastrointestinal malignancy: An intriguing link.World journal of gastrointestinal pathophysiology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 17 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Context: Safety concerns have been raised regarding premature mortality, diabetes, neoplasia, and cerebrovascular disease in association with GH therapy. Objective: To assess incidence of key safety outcomes. Design: Prospective, multinational, observational study (1999 to 2015). Setting: A total of 22,311 GH-treated children from 827 investigative sites in 30 countries. Patients: Children with growth disorders. Interventions: GH treatment. Main outcome measures: Standardized mortality ratio (SMR) and standardized incidence ratio (SIR) with 95% CIs for mortality, diabetes, and primary cancer using general population registries. Results: Predominant short stature diagnoses were GH deficiency (63%), idiopathic short stature (13%), and Turner syndrome (8%), with mean ± SD follow-up of 4.2 ± 3.2 years (∼92,000 person-years [PY]). Forty-two deaths occurred in patients with follow-up, with an SMR (95% CI) of 0.61 (0.44, 0.82); the SMR was elevated for patients with cancer-related organic GH deficiency [5.87 (3.21, 9.85)]. Based on 18 cases, type 2 diabetes mellitus (T2DM) risk was elevated [SIR: 3.77 (2.24, 5.96)], but 72% had risk factors. In patients without cancer history, 14 primary cancers were observed [SIR: 0.71 (0.39, 1.20)]. Second neoplasms occurred in 31 of 622 cancer survivors [5.0%; 10.7 (7.5, 15.2) cases/1000 PY] and intracranial tumor recurrences in 67 of 823 tumor survivors [8.1%; 16.9 (13.3, 21.5) cases/1000 PY]. All three hemorrhagic stroke cases had risk factors. Conclusions: GeNeSIS (Genetics and Neuroendocrinology of Short Stature International Study) data support the favorable safety profile of pediatric GH treatment. Overall risk of death or primary cancer was not elevated in GH-treated children, and no hemorrhagic strokes occurred in patients without risk factors. T2DM incidence was elevated compared with the general population, but most cases had diabetes risk factors.
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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.