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A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height (ZomaTrip)

Primary Purpose

Idiopathic Short Stature

Status
Active
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
somatropin
triptorelin
Sponsored by
Belgian Study Group for Pediatric Endocrinology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Short Stature focused on measuring gonadotropin releasing hormone agonist, growth hormone, final height, bone density, puberty

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult height prediction below -2.5 SD : 151 cm for girls and 164 cm for boys based on the vlaamse groeicurve 2004 (vub.ac.be/groeicurven)
  • Pubertal: breast development at least M2 for girls and at least 4 ml of testicular volume for boys
  • Bone age >10 years but < 12 years for girls and > 11 but < 13 years for boys
  • Signed informed consent

Exclusion Criteria:

  • Adopted children ( different genetic background, lack of data on birth parameters and parents)
  • Bone dysplasia or sitting height/ total height > 2 SDS on standards by Gerver et al (see appendix)
  • Chronic use of glucocorticoids
  • Previous growth promoting therapy such as GH, sex steroids, oxandrolone,
  • Known GH deficiency
  • Chronic infectious disease
  • Active rheumatic disease
  • Previously diagnosed or currently suspected malignancy
  • Sex steroid therapy
  • Diabetes mellitus
  • Renal insufficiency (serum creatinine > 1.5 mg/dl)
  • Hepatic disease ( liver test > 4 fold upper limit of normality)
  • Current congestive heart failure
  • Inability to follow the study protocol
  • Treatment with a non registered drug during the last 30 days before the moment of inclusion.

Sites / Locations

  • Antwerp University Hospital
  • Jessah Ziekenhuis
  • Kinderziekenhuis UGent
  • Hopital Universitaire Reine Fabiola (HUDERF)
  • Kinderziekenhuis UZ Brussel
  • CHU ND-des Bruyères

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ZOMATRIP

Arm Description

GnRH agonist triptorelin plus somatropin

Outcomes

Primary Outcome Measures

height
Difference between predicted height at start of treatment and adult height

Secondary Outcome Measures

bone density
Bone density SDS measured by DEXA

Full Information

First Posted
February 10, 2009
Last Updated
July 27, 2023
Sponsor
Belgian Study Group for Pediatric Endocrinology
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1. Study Identification

Unique Protocol Identification Number
NCT00840944
Brief Title
A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height
Acronym
ZomaTrip
Official Title
Efficacy and Safety of a 4 Year Combination Therapy of Growth Hormone and Gonadotropin- Releasing Hormone Agonist in Children With a Short Predicted Height.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Belgian Study Group for Pediatric Endocrinology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Estrogens are responsible for the disappearance of growth cartilage in the long bones at the end of the pubertal growth spurt both in boys and in girls. It is therefore hypothesized that stopping pubertal development and hence estrogen production, will prolong and increase the pubertal growth spurt, especially when growth hormone is given concommitantly. Boys in early puberty, with a bone age between 11 and 13 years and a predicted adult height below 163 cm or girls in early puberty with a bone age between 10 and 12 years and a predicted height under 151 cm will be treated with triptorelin 3.75 mg and Zomacton growth hormone for 4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Short Stature
Keywords
gonadotropin releasing hormone agonist, growth hormone, final height, bone density, puberty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZOMATRIP
Arm Type
Experimental
Arm Description
GnRH agonist triptorelin plus somatropin
Intervention Type
Drug
Intervention Name(s)
somatropin
Other Intervention Name(s)
growth hormone, zomacton
Intervention Description
somatropin 0.050 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
triptorelin
Other Intervention Name(s)
decapeptyl
Intervention Description
triptorelin 3.75 mg each month
Primary Outcome Measure Information:
Title
height
Description
Difference between predicted height at start of treatment and adult height
Time Frame
6 - 8 years
Secondary Outcome Measure Information:
Title
bone density
Description
Bone density SDS measured by DEXA
Time Frame
6 - 8 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult height prediction below -2.5 SD : 151 cm for girls and 164 cm for boys based on the vlaamse groeicurve 2004 (vub.ac.be/groeicurven) Pubertal: breast development at least M2 for girls and at least 4 ml of testicular volume for boys Bone age >10 years but < 12 years for girls and > 11 but < 13 years for boys Signed informed consent Exclusion Criteria: Adopted children ( different genetic background, lack of data on birth parameters and parents) Bone dysplasia or sitting height/ total height > 2 SDS on standards by Gerver et al (see appendix) Chronic use of glucocorticoids Previous growth promoting therapy such as GH, sex steroids, oxandrolone, Known GH deficiency Chronic infectious disease Active rheumatic disease Previously diagnosed or currently suspected malignancy Sex steroid therapy Diabetes mellitus Renal insufficiency (serum creatinine > 1.5 mg/dl) Hepatic disease ( liver test > 4 fold upper limit of normality) Current congestive heart failure Inability to follow the study protocol Treatment with a non registered drug during the last 30 days before the moment of inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilde Dotremont, MD
Organizational Affiliation
BSGPE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Jessah Ziekenhuis
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Kinderziekenhuis UGent
City
Gent
State/Province
Oost Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hopital Universitaire Reine Fabiola (HUDERF)
City
Brussels
ZIP/Postal Code
1050
Country
Belgium
Facility Name
Kinderziekenhuis UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
CHU ND-des Bruyères
City
Liege
ZIP/Postal Code
4030
Country
Belgium

12. IPD Sharing Statement

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A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height

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