A 4 Year Combination Therapy of Growth Hormone (GH) and Gonadotropin-Releasing Hormone (GnRH) Agonist in Children With a Short Predicted Height - Full Text View

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

This study is currently recruiting participants.

Verified by Belgian Study Group for Pediatric Endocrinology, February 2009

First Received: February 10, 2009 No Changes Posted

Sponsor:	Belgian Study Group for Pediatric Endocrinology
Information provided by:	Belgian Study Group for Pediatric Endocrinology
ClinicalTrials.gov Identifier:	NCT00840944

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 IV

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:

Drug Information available for: Somatropin Gonadorelin Gonadorelin hydrochloride Triptorelin Triptorelin pamoate Somatotropin LH-RH

U.S. FDA Resources

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
ZOMATRIP: Experimental combination therapy of GnRH agonist and growth hormone	Drug: somatropin somatropin 0.050 mg/kg/day Drug: triptorelin triptorelin 3.75 mg each month
control: No Intervention

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

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
Kinderziekenhuis UZ Brussel	Recruiting
Brussel, Belgium, 1090
Contact: Jean De Schepper, MD PhD jean.deschepper@uzbrussel.be
Principal Investigator: Jean De Schepper, MD PhD
Belgium, Antwerpen
Antwerp University Hospital	Recruiting
Edegem, Antwerpen, Belgium, 2650
Contact: Raoul P Rooman, MD PhD +3238214009 raoul.rooman@uza.be
Principal Investigator: Raoul P Rooman, MD PhD
Belgium, Limburg
Virga Jesse Ziekenhuis	Recruiting
Hasselt, Limburg, Belgium, 3000
Contact: Guy Massa, MD PhD
Principal Investigator: Guy Massa, MD PhD
Belgium, Oost Vlaanderen
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 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:	Antwerp University Hospital ( Raoul Rooman MD PhD )
Study ID Numbers:	EUDRACT 2007-003247-70
Study First Received:	February 10, 2009
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00840944 History of Changes
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:

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Triptorelin
Therapeutic Uses
Physiological Effects of Drugs

Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Luteolytic Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 18, 2010