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 ongoing, but not recruiting participants.
Sponsor:
Belgian Study Group for Pediatric Endocrinology
Information provided by:
Belgian Study Group for Pediatric Endocrinology
ClinicalTrials.gov Identifier:
NCT00840944
First received: February 10, 2009
Last updated: June 2, 2010
Last verified: June 2010
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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:
Drug Information available for:
Somatropin
Gonadorelin
Gonadorelin hydrochloride
Triptorelin pamoate
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 |
|---|---|
|
Experimental: ZOMATRIP
combination therapy of GnRH agonist and growth hormone
|
Drug: somatropin
somatropin 0.050 mg/kg/day
Other Names:
Drug: triptorelin
triptorelin 3.75 mg each month
Other Name: decapeptyl
|
| No Intervention: control |
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
Locations
| Belgium | |
| Antwerp University Hospital | |
| Edegem, Antwerpen, Belgium, 2650 | |
| Virga Jesse Ziekenhuis | |
| Hasselt, Limburg, Belgium, 3000 | |
| Kinderziekenhuis UGent | |
| Gent, Oost Vlaanderen, Belgium, 9000 | |
| Kinderziekenhuis UZ Brussel | |
| Brussel, Belgium, 1090 | |
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, Antwerp University Hospital |
| ClinicalTrials.gov Identifier: | NCT00840944 History of Changes |
| Other Study ID Numbers: | EUDRACT 2007-003247-70 |
| Study First Received: | February 10, 2009 |
| Last Updated: | June 2, 2010 |
| 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 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 May 16, 2013