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

April 8, 2019 updated by: Göteborg University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interventional
Unchanged dose Genotropin
Drug: Genotropin
Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth
Active Comparator: Interventional 2
reduced dose 50% Genotropin
Drug: Genotropin
Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
twelve months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IGF-I
Time Frame: 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.
start of study to two years after start in the trial
Height SDS at Start of Puberty
Time Frame: 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
1-7 years in the trial

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Height
Time Frame: start of study to two years after start in the trial
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)
start of study to two years after start in the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Berit Kriström, MD, Umeå University Hospital
  • Principal Investigator: Nils-Östen Nilsson, MD, Halmstad Department of Pediatrics
  • Principal Investigator: Maria Halldin, MD, Uppsala University Hospital
  • Principal Investigator: Sten Ivarsson, MD, Prof, Malmö Academic Hospital
  • Principal Investigator: Kerstin Albertsson-Wikland, MD, prof, Gothenburg University, Departments of pediatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2003

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRA 6280003

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol
    Information comments: The document will be found under "Trials" and then "GH-dose/Maintenance study"
  2. Statistical Analysis Plan
    Information comments: The document will be found under "Trials" and then "GH-dose/Maintenance study"

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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