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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZOMATRIP | Experimental | GnRH agonist triptorelin plus somatropin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin | Drug | somatropin 0.050 mg/kg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| height | Difference between predicted height at start of treatment and adult height | 6 - 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| bone density | Bone density SDS measured by DEXA | 6 - 8 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilde Dotremont, MD | BSGPE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Edegem | Antwerpen | 2650 | Belgium | ||
| Jessah Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37008942 | Derived | Dotremont H, France A, Heinrichs C, Tenoutasse S, Brachet C, Cools M, De Waele K, Massa G, Lebrethon MC, Gies I, Van Besien J, Derycke C, Ziraldo M, De Schepper J, Beauloye V, Verhulst S, Rooman R, den Brinker M. Efficacy and safety of a 4-year combination therapy of growth hormone and gonadotropin-releasing hormone analogue in pubertal girls with short predicted adult height. Front Endocrinol (Lausanne). 2023 Mar 17;14:1113750. doi: 10.3389/fendo.2023.1113750. eCollection 2023. |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D013006 | Growth Hormone |
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| triptorelin | Drug | triptorelin 3.75 mg each month |
|
|
| Hasselt |
| Limburg |
| 3000 |
| Belgium |
| Kinderziekenhuis UGent | Ghent | Oost Vlaanderen | 9000 | Belgium |
| Hopital Universitaire Reine Fabiola (HUDERF) | Brussels | 1050 | Belgium |
| Kinderziekenhuis UZ Brussel | Brussels | 1090 | Belgium |
| CHU ND-des Bruyères | Liège | 4030 | Belgium |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D009479 | Neuropeptides |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |