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

Primary Purpose

Short Stature

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Genotropin

About this trial

This is an interventional treatment trial for Short Stature focused on measuring treatment, growth hormone, childhood, short stature

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Interventional

Interventional 2

Arm Description

Unchanged dose Genotropin

reduced dose 50% Genotropin

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT02879747

First Posted

August 10, 2016

Last Updated

April 8, 2019

Sponsor

Göteborg University

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02879747

Brief Title

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

Acronym

MAINTENANCE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

December 2003 (Actual)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Göteborg University

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Short Stature

Keywords

treatment, growth hormone, childhood, short stature

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interventional

Arm Type

Active Comparator

Arm Description

Unchanged dose Genotropin

Arm Title

Interventional 2

Arm Type

Active Comparator

Arm Description

reduced dose 50% Genotropin

Intervention Type

Drug

Intervention Name(s)

Genotropin

Intervention Description

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

Primary Outcome Measure Information:

Title

The Proportion of Children Maintaining Normal Growth Velocity

Description

Time Frame

twelve months

Secondary Outcome Measure Information:

Title

IGF-I

Description

Time Frame

start of study to two years after start in the trial

Title

Height SDS at Start of Puberty

Description

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

Other Pre-specified Outcome Measures:

Title

Changes in Height

Description

Changes in height standard deviation scores (SDS) (calculated as height in cm at start converted to SDS and height in cm after two years in the trial converted to SDS)

Time Frame

start of study to two years after start in the trial

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: