NCT00840944

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

16 years

First QC Date

February 10, 2009

Last Update Submit

July 27, 2023

Conditions

Idiopathic Short Stature

Keywords

gonadotropin releasing hormone agonistgrowth hormonefinal heightbone densitypuberty

Outcome Measures

Primary Outcomes (1)

  • height

    Difference between predicted height at start of treatment and adult height

    6 - 8 years

Secondary Outcomes (1)

  • bone density

    6 - 8 years

Study Arms (1)

ZOMATRIP

EXPERIMENTAL

GnRH agonist triptorelin plus somatropin

Drug: somatropinDrug: triptorelin

Interventions

somatropinDRUG

somatropin 0.050 mg/kg/day

Also known as: growth hormone, zomacton
ZOMATRIP
triptorelinDRUG

triptorelin 3.75 mg each month

Also known as: decapeptyl
ZOMATRIP

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Antwerp University Hospital

Edegem, Antwerpen, 2650, Belgium

Location

Jessah Ziekenhuis

Hasselt, Limburg, 3000, Belgium

Location

Kinderziekenhuis UGent

Ghent, Oost Vlaanderen, 9000, Belgium

Location

Hopital Universitaire Reine Fabiola (HUDERF)

Brussels, 1050, Belgium

Location

Kinderziekenhuis UZ Brussel

Brussels, 1090, Belgium

Location

CHU ND-des Bruyères

Liège, 4030, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 37008942DERIVED

MeSH Terms

Interventions

Human Growth HormoneGrowth HormoneTriptorelin Pamoate

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesNeuropeptidesOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Hilde Dotremont, MD

    BSGPE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2024

Study Completion

April 1, 2024

Last Updated

July 28, 2023

Record last verified: 2023-07

Locations

BE(6)