Status:
UNKNOWN
A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height
Lead Sponsor:
Belgian Study Group for Pediatric Endocrinology
Conditions:
Idiopathic Short Stature
Eligibility:
All Genders
7-15 years
Phase:
PHASE4
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 pube...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00840944
Start Date
January 1 2008
End Date
April 1 2024
Last Update
July 28 2023
Active Locations (6)
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1
Antwerp University Hospital
Edegem, Antwerpen, Belgium, 2650
2
Jessah Ziekenhuis
Hasselt, Limburg, Belgium, 3000
3
Kinderziekenhuis UGent
Ghent, Oost Vlaanderen, Belgium, 9000
4
Hopital Universitaire Reine Fabiola (HUDERF)
Brussels, Belgium, 1050