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

Göteborg University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Short Stature

Treatments

Drug: Genotropin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02879747

NRA 6280003

Details and patient eligibility

About

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).

Full 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.

Enrollment

99 patients

Sex

All

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

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.