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

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ClinicalTrials.gov Identifier: NCT00840944
Recruitment Status : Active, not recruiting
First Posted : February 11, 2009
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Hilde Dotremont, Belgian Study Group for Pediatric Endocrinology

Tracking Information
First Submitted Date  ICMJE February 10, 2009
First Posted Date  ICMJE February 11, 2009
Last Update Posted Date November 30, 2017
Study Start Date  ICMJE January 2008
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
height [ Time Frame: 6 - 8 years ]
Difference between predicted height at start of treatment and adult height
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2009)
height [ Time Frame: 6 - 8 years ]
Change History Complete list of historical versions of study NCT00840944 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
bone density [ Time Frame: 6 - 8 years ]
Bone density SDS measured by DEXA
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2009)
bone density [ Time Frame: 6 - 8 years ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height
Official Title  ICMJE Efficacy and Safety of a 4 Year Combination Therapy of Growth Hormone and Gonadotropin- Releasing Hormone Agonist in Children With a Short Predicted Height.
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Short Stature
Intervention  ICMJE
  • Drug: somatropin
    somatropin 0.050 mg/kg/day
    Other Names:
    • growth hormone
    • zomacton
  • Drug: triptorelin
    triptorelin 3.75 mg each month
    Other Name: decapeptyl
Study Arms Experimental: ZOMATRIP
GnRH agonist triptorelin plus somatropin
Interventions:
  • Drug: somatropin
  • Drug: triptorelin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 23, 2017)
44
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2009)
30
Estimated Study Completion Date April 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00840944
Other Study ID Numbers  ICMJE EUDRACT 2007-003247-70
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hilde Dotremont, Belgian Study Group for Pediatric Endocrinology
Study Sponsor  ICMJE Belgian Study Group for Pediatric Endocrinology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hilde Dotremont, MD BSGPE
PRS Account Belgian Study Group for Pediatric Endocrinology
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP