Individualizing the Dose of Growth Hormone (GH) to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children Within TR 98-0198-003
Overview
- Phase
- Phase 2
- Intervention
- Genotropin
- Conditions
- Short Stature
- Sponsor
- Göteborg University
- Enrollment
- 99
- Primary Endpoint
- The Proportion of Children Maintaining Normal Growth Velocity
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participated in the 'GH-dose catch-up study' 98- 0198-
- •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.
Arms & Interventions
Interventional
Unchanged dose Genotropin
Intervention: Genotropin
Interventional 2
reduced dose 50% Genotropin
Intervention: Genotropin
Outcomes
Primary Outcomes
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
- IGF-I(start of study to two years after start in the trial)
- Height SDS at Start of Puberty(1-7 years in the trial)