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

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ClinicalTrials.gov Identifier: NCT02879747
Recruitment Status : Completed
First Posted : August 26, 2016
Results First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Short Stature Drug: Genotropin Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2003
Actual Primary Completion Date : March 2012
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dwarfism Hormones

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


  2. 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


Other Outcome Measures:
  1. 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)



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879747


Sponsors and Collaborators
Göteborg University
Pfizer
Investigators
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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

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
The document will be found under "Trials" and then "GH-dose/Maintenance study"
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
The document will be found under "Trials" and then "GH-dose/Maintenance study"

Publications of Results:
Other Publications:
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02879747     History of Changes
Other Study ID Numbers: NRA 6280003
First Posted: August 26, 2016    Key Record Dates
Results First Posted: April 30, 2019
Last Update Posted: April 30, 2019
Last Verified: April 2019
Keywords provided by Göteborg University:
treatment
growth hormone
childhood
short stature
Additional relevant MeSH terms:
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Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs