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

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ClinicalTrials.gov Identifier: NCT00840944
Recruitment Status : Active, not recruiting
First Posted : February 11, 2009
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Hilde Dotremont, Belgian Study Group for Pediatric Endocrinology

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.


Condition or disease Intervention/treatment Phase
Idiopathic Short Stature Drug: somatropin Drug: triptorelin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2008
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ZOMATRIP
GnRH agonist triptorelin plus somatropin
Drug: somatropin
somatropin 0.050 mg/kg/day
Other Names:
  • growth hormone
  • zomacton
Drug: triptorelin
triptorelin 3.75 mg each month
Other Name: decapeptyl



Primary Outcome Measures :
  1. height [ Time Frame: 6 - 8 years ]
    Difference between predicted height at start of treatment and adult height


Secondary Outcome Measures :
  1. bone density [ Time Frame: 6 - 8 years ]
    Bone density SDS measured by DEXA



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Ages Eligible for Study:   7 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT00840944


Locations
Belgium
Antwerp University Hospital
Edegem, Antwerpen, Belgium, 2650
Jessah Ziekenhuis
Hasselt, Limburg, Belgium, 3000
Kinderziekenhuis UGent
Gent, Oost Vlaanderen, Belgium, 9000
Hopital Universitaire Reine Fabiola (HUDERF)
Brussels, Belgium, 1050
Kinderziekenhuis UZ Brussel
Brussel, Belgium, 1090
CHU ND-des Bruyères
Liege, Belgium, 4030
Sponsors and Collaborators
Belgian Study Group for Pediatric Endocrinology
Investigators
Principal Investigator: Hilde Dotremont, MD BSGPE

Responsible Party: Hilde Dotremont, MD, Belgian Study Group for Pediatric Endocrinology
ClinicalTrials.gov Identifier: NCT00840944     History of Changes
Other Study ID Numbers: EUDRACT 2007-003247-70
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

Keywords provided by Hilde Dotremont, Belgian Study Group for Pediatric Endocrinology:
gonadotropin releasing hormone agonist
growth hormone
final height
bone density
puberty

Additional relevant MeSH terms:
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Hormones
Triptorelin Pamoate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents