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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2017-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Short Stature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional

Unchanged dose Genotropin

Group Type ACTIVE_COMPARATOR

Genotropin

Intervention Type DRUG

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

Interventional 2

reduced dose 50% Genotropin

Group Type ACTIVE_COMPARATOR

Genotropin

Intervention Type DRUG

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

Interventions

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Genotropin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No