Skip to content

Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children

Short name MAINTENANCE

NCTNCT02879747 (opens ClinicalTrials.gov in a new tab)Other idNRA 6280003
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
99 participants (actual)
Sponsor
Göteborg University · Other
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
Dec 2003
Primary completion
Mar 2012
Completion
Dec 2017
First posted
26 Aug 2016 (estimated)
Last update posted
30 Apr 2019
Conditions
Short Stature

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520102015
  1. Ph 2/3

    MAINTENANCE

    NCT02879747

    Dec 2003 to Dec 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • GenotropinDrug

Arms2

  • Active comparator

    Interventional

    Unchanged dose Genotropin

  • Active comparator

    Interventional 2

    reduced dose 50% Genotropin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The Proportion of Children Maintaining Normal Growth Velocity

    Time frame · twelve months

    Registry description

    The proportion of children in the intervention 1 group (=reduced dose) that maintained an individual ΔheightSDS within ±0.3 during the first year of the Maintenance trial, compared to the proportion of children in the intervention 2 group (non-reduced dose)

Secondary outcomes(2)

  1. IGF-I

    Time frame · start of study to two years after start in the trial

    Registry description

    Delta Insulin-like growth factor-I (24 months after start compared to start of study) expressed as ng/ml and converted to standard deviation scores (SDS) to adjust for gender and age. A standard deviation score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A mean value within +-0.5 SDS and a range within +-1.0 SDS is a favorable outcome.

  2. Height SDS at Start of Puberty

    Time frame · 1-7 years in the trial

    Registry description

    Height at start of puberty measured as cm and expressed as standard deviation score (SDS) to adjust for age and gender

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· twelve months

The Proportion of Children Maintaining Normal Growth Velocity

GroupValue (Participants)
Decreased GH Dose23
Interventional 232
Control Group31
Secondary and other outcome results(3)
Secondary outcomeMean· start of study to two years after start in the trial

IGF-I

GroupValue (standard deviation scores)Spread
Unchanged Dose-1.101.14
Reduced Dose0.580.91
Control Group-0.061.26
Secondary outcomeMean· 1-7 years in the trial

Height SDS at Start of Puberty

GroupValue (standard deviation scores)Spread
Decreased GH Dose-1.01.02
Unchanged GH Dose-1.060.84
Control Group-0.980.91
Other pre specified outcomeMean· start of study to two years after start in the trial

Changes in Height

GroupValue (standard deviation scores)Spread
Unchanged Dose0.180.16
Reduced Dose0.570.36
Control Group0.550.26

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Decreased GH DoseReduced dose 50% Genotropin Children were randomized to decreased GH dose by 50% after 2-3 years of Catch-up growth0 / 273 / 2720 / 27
Unchanged GH DoseUnchanged dose Children were randomized to unchanged dose after 2-3 years of Catch-up growth0 / 384 / 3825 / 38
Control GroupControl Group with fix dose. Children that were randomized to fix dose in the previous and current trial and signed informed consent0 / 333 / 3324 / 33

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2024

Interpreting IGF-1 in children treated with recombinant growth hormone: challenges during early puberty.

Ly et al. 2024Frontiers in endocrinologycited by 2

PMID 39906034PMC11790427DOI 10.3389/fendo.2024.1514935PUB-39906034

CC BY
Download PDF

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultKristrom 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. PMID 19001519
  • DerivedDecker 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. PMID 30339244

Eligibility

Who could join, as posted.

Sex
All
Age
from 4 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.