Clinical trial NCT00840944: A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height
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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Idiopathic Short Stature
Keywords: gonadotropin releasing hormone agonist
growth hormone
final height
bone density
puberty
Lead sponsor: Belgian Study Group for Pediatric Endocrinology
Sponsor class: OTHER
First posted: 2009-02-11
Enrollment: 44
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility 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.

Primary outcomes:
measure: height
timeFrame: 6 - 8 years
Secondary outcomes:
measure: bone density
timeFrame: 6 - 8 years
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerpen
city: Hasselt
country: Belgium
facility: Jessah Ziekenhuis
state: Limburg
city: Gent
country: Belgium
facility: Kinderziekenhuis UGent
state: Oost Vlaanderen
city: Brussels
country: Belgium
facility: Hopital Universitaire Reine Fabiola (HUDERF)
city: Brussel
country: Belgium
facility: Kinderziekenhuis UZ Brussel
city: Liege
country: Belgium
facility: CHU ND-des Bruyères
Study officials:
affiliation: BSGPE
name: Hilde Dotremont, MD
role: PRINCIPAL_INVESTIGATOR
References: