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Active, not recruitingNCT00840944ZomaTripUpdated Jul 28, 2023

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

A Phase 4 interventional study of somatropin and triptorelin in Idiopathic Short Stature, sponsored by Belgian Study Group for Pediatric Endocrinology. Active, not recruiting at 6 sites in Belgium. Open to participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2023-07-28.

Sponsored by Belgian Study Group for Pediatric Endocrinology · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
7 Years to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Idiopathic Short Stature

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Keywords

  • gonadotropin releasing hormone agonist
  • growth hormone
  • final height
  • bone density
  • puberty
03

Who can participate

Ages eligible
7 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    ZOMATRIP

    GnRH agonist triptorelin plus somatropin

    Drug: somatropin · Drug: triptorelin

Interventions

  • Drugsomatropin

    somatropin 0.050 mg/kg/day

    Also known as: growth hormone, zomacton

  • Drugtriptorelin

    triptorelin 3.75 mg each month

    Also known as: decapeptyl

05

What researchers measure

Primary outcomes

  1. height

    Difference between predicted height at start of treatment and adult height

    Time frame: 6 - 8 years

Secondary outcomes

  1. bone density

    Bone density SDS measured by DEXA

    Time frame: 6 - 8 years

06

Study locations

6 sites
  • Antwerp University Hospital
    Edegem, Antwerpen 2650, Belgium
  • Jessah Ziekenhuis
    Hasselt, Limburg 3000, Belgium
  • Kinderziekenhuis UGent
    Gent, Oost Vlaanderen 9000, Belgium
  • Hopital Universitaire Reine Fabiola (HUDERF)
    Brussels, 1050, Belgium
  • Kinderziekenhuis UZ Brussel
    Brussel, 1090, Belgium
  • CHU ND-des Bruyères
    Liege, 4030, Belgium
07

Registry details

Key details

Study ID
NCT00840944
Lead sponsor
Belgian Study Group for Pediatric Endocrinology
Responsible party
Hilde Dotremont (MD, Belgian Study Group for Pediatric Endocrinology) — Principal investigator
First posted
Feb 11, 2009
Start date
Jan 2008
Primary completion
Jan 2024 (estimated)
Completion
Apr 2024 (estimated)
Last update
Jul 28, 2023

Study contacts

Hilde Dotremont, MD
principal investigator · BSGPE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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