Skip to main content
OpenTrials
Completed

NCT Number: NCT02879747

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Short Stature Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Endocrine System Diseases Genetic Diseases, Inborn Musculoskeletal Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Genotropin

Drug

Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth

Primary outcomes

  1. The Proportion of Children Maintaining Normal Growth Velocity

    Time frame: twelve months

    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

  1. IGF-I

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

    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

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

Other outcomes

  1. Changes in Height

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

    Changes in height standard deviation scores (SDS) (calculated as height in cm at start converted to SDS and height in cm after two years in the trial converted to SDS)

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Pfizer

Registry information

Official study 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

Acronym: MAINTENANCE

Important dates

Study start
2003
Primary completion
2012
Study completion
2017
First posted
Aug 26, 2016
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.