Clinical trial NCT02879747: Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children
Official title: Individualizing the Dose of Growth Hormone (GH) to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children Within TR 98-0198-003
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Short Stature
Keywords: treatment
growth hormone
childhood
short stature
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2016-08-26
Enrollment: 99
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: The aim of the trial is to study the effect of adapted GH treatment in order to find an individualized GH dose maintaining normal growth velocity close to target height SDS and normal metabolism after fulfilled catch up growth in prepubertal children treated with individual doses of GH within the trial 98-0198-003 (1). The overall aim is to find for the individual the lowest effective GH dose during maintenance period, maintaining normal growth velocity and metabolism, i.e. a satisfactory biological active dose.

Eligibility criteria: Inclusion Criteria:

* Participated in the 'GH-dose catch-up study' 98- 0198-003.
* Midparental height reached (difference less than 0.6 SDS)
* Prepubertal at start of the study (girls =B 1, boys: testes :\<; 3ml).
* Signed written informed consent from the patient's parents (and the child if old enough)

Exclusion Criteria:

* Disease affecting growth other than correctly treated hypothyroidism.
* Incapable of following the study protocol (i.e. bad compliance in the previous study).
* Puberty (\> breast stage 2, or testes \> 4ml).
* Poor compliance.

Primary outcomes:
measure: The Proportion of Children Maintaining Normal Growth Velocity
timeFrame: twelve months
Secondary outcomes:
measure: IGF-I
timeFrame: start of study to two years after start in the trial
measure: Height SDS at Start of Puberty
timeFrame: 1-7 years in the trial
Other outcomes:
measure: Changes in Height
timeFrame: start of study to two years after start in the trial
Locations:
Study officials:
affiliation: Umeå University Hospital
name: Berit Kriström, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Halmstad Department of Pediatrics
name: Nils-Östen Nilsson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University Hospital
name: Maria Halldin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Malmö Academic Hospital
name: Sten Ivarsson, MD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Gothenburg University, Departments of pediatrics
name: Kerstin Albertsson-Wikland, MD, prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.