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A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height
Plain-language guide to NCT00840944: phase 4 interventional trial of Triptorelin, 44 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00840944
- Phase
- phase 4
- Status
- status unknown
- Start
- 2008-01
- Completion (planned or actual)
- 2024-01
- Participants
- 44 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Idiopathic Short Stature
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Triptorelin.
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 had 1 arm (groups): ZOMATRIP (experimental).
GnRH agonist triptorelin plus somatropin.
The registry classes the interventions as drug.
Who Took Part
The registry lists 44 actual participants took part.
It was open to people of any sex aged from 7 years up to 15 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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). Bone age \>10 years but \< 12 years for girls and \> 11 but \< 13 years for boys. Signed informed consent.
The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: 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.
How the Study Was Run
It was run as a single-group and open-label study.
Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2008-01 with completion listed for 2024-01.
It ran at 6 sites in Belgium (6).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): height (time frame: 6 - 8 years).
It also tracked 1 secondary outcome, for example bone density.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Triptorelin in 44 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Triptorelin compound page, all human trials.
Our Notes on the Compound
Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.