A 4 Year Combination Therapy of Growth Hormone (GH) and Gonadotropin-Releasing Hormone (GnRH) Agonist in Children With a Short Predicted Height
Information source: Belgian Study Group for Pediatric Endocrinology
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Idiopathic Short Stature
Intervention: somatropin (Drug); triptorelin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Belgian Study Group for Pediatric Endocrinology Official(s) and/or principal investigator(s):
Raoul P Rooman, MD,PhD, Principal Investigator, Affiliation: BSGPE
Overall contact:
Raoul P Rooman, MD PhD, Phone: +32 3 821 4009, Email: raoul.rooman@uza.be
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: height
Secondary outcome: bone density
Eligibility
Minimum age: 7 Years.
Maximum age: 15 Years.
Gender(s): Both.
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.
Locations and Contacts
Raoul P Rooman, MD PhD, Phone: +32 3 821 4009, Email: raoul.rooman@uza.be
Kinderziekenhuis UZ Brussel, Brussel 1090, Belgium; Recruiting
Jean De Schepper, MD PhD, Email: jean.deschepper@uzbrussel.be
Jean De Schepper, MD PhD, Principal Investigator
Antwerp University Hospital, Edegem, Antwerpen 2650, Belgium; Recruiting
Raoul P Rooman, MD PhD, Phone: +3238214009, Email: raoul.rooman@uza.be
Raoul P Rooman, MD PhD, Principal Investigator
Virga Jesse Ziekenhuis, Hasselt, Limburg 3000, Belgium; Recruiting
Guy Massa, MD PhD
Guy Massa, MD PhD, Principal Investigator
Kinderziekenhuis UGent, Gent, Oost Vlaanderen 9000, Belgium; Recruiting
Kathleen Dewaele, MD PhD
Martine Cools, MD PhD, Email: martine.cools@ugent.be
Kathleen Dewaele, MD PhD, Principal Investigator
Additional Information
Starting date: January 2008
Ending date: April 2017
Last updated: February 10, 2009
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