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

Göteborg University99 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Short Stature

Interventions

GenotropinDRUG

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: twelve months

Secondary Outcomes

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.

Time frame: 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

Time frame: 1-7 years in the trial

Data from ClinicalTrials.gov

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