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Trial · Interventional

Status unknownPhase 4Registry data

A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height

Short name ZomaTrip

NCTNCT00840944 (opens ClinicalTrials.gov in a new tab)Other idEUDRACT 2007-003247-70
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
44 participants (actual)
Sponsor
Belgian Study Group for Pediatric Endocrinology · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Belgium

Start
Jan 2008
Primary completion
Jan 2024 (estimated)
Completion
Apr 2024 (estimated)
First posted
11 Feb 2009 (estimated)
Last update posted
28 Jul 2023
Conditions
Idiopathic Short Stature

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201520202025
  1. Ph 4

    ZomaTrip

    NCT00840944

    Jan 2008 to est. Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • somatropinDrug
  • triptorelinDrug

Arms1

  • Experimental

    ZOMATRIP

    GnRH agonist triptorelin plus somatropin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. height

    Time frame · 6 - 8 years

    Registry description

    Difference between predicted height at start of treatment and adult height

Secondary outcomes(1)

  1. bone density

    Time frame · 6 - 8 years

    Registry description

    Bone density SDS measured by DEXA

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedDotremont 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. PMID 37008942

Eligibility

Who could join, as posted.

Sex
All
Age
from 7 Years up to 15 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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