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

Phase 2

Completed

• Conditions: Short Stature
• Interventions: Drug: Genotropin

• Registration Number: NCT02879747
• Lead Sponsor: Göteborg University

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.

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2012-03
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-26
• Study Completion: 2017-12
• Results First Submitted: 2018-11-21
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-08
• Last Update Submitted: 2019-04-08
• Results First Posted: 2019-04-30
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional 2	Genotropin	reduced dose 50% Genotropin
Interventional	Genotropin	Unchanged dose Genotropin

Primary Outcome Measures

Name	Time	Method
The Proportion of Children Maintaining Normal Growth Velocity	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 Outcome Measures

Name	Time	Method
IGF-I	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.
Height SDS at Start of Puberty	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