A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predic… (NCT00840944) | Clinical Trial Compass
UnknownPhase 4
A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height
Belgium44 participantsStarted 2008-01
Plain-language 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.
Who can participate
Age range
7 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
height
Timeframe: 6 - 8 years
Trial details
NCT IDNCT00840944
SponsorBelgian Study Group for Pediatric Endocrinology