drugset / Trial / NCT02879747
Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective was to study whether normal growth velocity can be maintained with adapted GH dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled catch up growth (=difference to target height reached, less than - 0.6 SDS).
Timeline
- Start
- 2003-12
- Primary completion
- 2012-03
- Completion
- 2017-12
Publications
- Background Wikland KA, Kristrom B, Rosberg S, Svensson B, Nierop AF. Validated multivariate models predicting the growth response to GH treatment in individual short children with a broad range in GH secretion capacities. Pediatr Res. 2000 Oct;48(4):475-84. doi: 10.1203/00006450-200010000-00010.
- Results Kristrom B, Aronson AS, Dahlgren J, Gustafsson J, Halldin M, Ivarsson SA, Nilsson NO, Svensson J, Tuvemo T, Albertsson-Wikland K. Growth hormone (GH) dosing during catch-up growth guided by individual responsiveness decreases growth response variability in prepubertal children with GH deficiency or idiopathic short stature. J Clin Endocrinol Metab. 2009 Feb;94(2):483-90. doi: 10.1210/jc.2008-1503. Epub 2008 Nov 11.
- Ly HJ, Ankarberg-Lindgren C, Fors H, Nilsson S, Dahlgren J. Interpreting IGF-1 in children treated with recombinant growth hormone: challenges during early puberty. Front Endocrinol (Lausanne). 2025 Jan 21;15:1514935. doi: 10.3389/fendo.2024.1514935. eCollection 2024.
- Decker R, Albertsson-Wikland K, Kristrom B, Halldin M, Gustafsson J, Nilsson NO, Dahlgren J. GH Dose Reduction Maintains Normal Prepubertal Height Velocity After Initial Catch-Up Growth in Short Children. J Clin Endocrinol Metab. 2019 Mar 1;104(3):835-844. doi: 10.1210/jc.2018-01006.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Somatropin | Protein / enzyme biologic | — | — |