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

Study Overview
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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).

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.

Official Title
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Individualizing the Dose of Growth Hormone (GH) to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children Within TR 98-0198-003

Conditions
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Short Stature

Intervention / Treatment
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* Drug: Genotropin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interventional<br>Unchanged dose Genotropin | Drug: Genotropin<br>* Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth<br>|
| Active Comparator: Interventional 2<br>reduced dose 50% Genotropin | Drug: Genotropin<br>* Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Children Maintaining Normal Growth Velocity | 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) | twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-I | 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. | start of study to two years after start in the trial | 
| Height SDS at Start of Puberty | Height at start of puberty measured as cm and expressed as standard deviation score (SDS) to adjust for age and gender | 1-7 years in the trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment, growth hormone, childhood, short stature