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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Belgian Study Group for Pediatric Endocrinology
Sponsor:
Information provided by (Responsible Party):
Raoul Rooman, Belgian Study Group for Pediatric Endocrinology
ClinicalTrials.gov Identifier:
NCT00840944
First received: February 10, 2009
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Idiopathic Short Stature
Drug: somatropin
Drug: triptorelin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Belgian Study Group for Pediatric Endocrinology:

Primary Outcome Measures:
  • height [ Time Frame: 6 - 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bone density [ Time Frame: 6 - 8 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2008
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: control
no treatment

  Eligibility

Ages Eligible for Study:   7 Years to 15 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840944

Contacts
Contact: Raoul P Rooman, MD PhD +32 3 821 4009 raoul.rooman@uza.be

Locations
Belgium
Antwerp University Hospital Recruiting
Edegem, Antwerpen, Belgium, 2650
Contact: Annick France, MD    +3238215549    annick.france@uza.be   
Principal Investigator: Annick France, MD         
Sub-Investigator: Hilde Dotremont, MD         
Virga Jesse Ziekenhuis Recruiting
Hasselt, Limburg, Belgium, 3000
Contact: Guy Massa, MD PhD         
Principal Investigator: Guy Massa, MD PhD         
Kinderziekenhuis UGent Recruiting
Gent, Oost Vlaanderen, Belgium, 9000
Contact: Kathleen Dewaele, MD PhD         
Contact: Martine Cools, MD PhD       martine.cools@ugent.be   
Principal Investigator: Kathleen Dewaele, MD         
Principal Investigator: Martine COOLS, MD, PhD         
Kinderziekenhuis UZ Brussel Recruiting
Brussel, Belgium, 1090
Contact: Jean De Schepper, MD PhD       jean.deschepper@uzbrussel.be   
Principal Investigator: Jean De Schepper, MD PhD         
Hopital Universitaire Reine Fabiola (HUDERF) Recruiting
Brussels, Belgium, 1050
Principal Investigator: Claudine Heinrichs, MD, PhD         
Principal Investigator: Sylvie TENOUTASSE, MD         
Principal Investigator: Cecile BRACHET, MD         
CHU ND-des Bruyères Recruiting
Liege, Belgium, 4030
Contact: Jean-Pierre Bourguignon, MD,PhD         
Principal Investigator: Jean-Pierre Bourguignon, MD,PhD         
Principal Investigator: Marie-Christine Lebrethon, MD,PhD         
Principal Investigator: Anne-Simone PARENT, MD,PhD         
Sponsors and Collaborators
Belgian Study Group for Pediatric Endocrinology
Investigators
Principal Investigator: Raoul P Rooman, MD,PhD BSGPE
  More Information

No publications provided

Responsible Party: Raoul Rooman, MD, PhD, Belgian Study Group for Pediatric Endocrinology
ClinicalTrials.gov Identifier: NCT00840944     History of Changes
Other Study ID Numbers: EUDRACT 2007-003247-70
Study First Received: February 10, 2009
Last Updated: August 7, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by 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
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014