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

Information source: Belgian Study Group for Pediatric Endocrinology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Short Stature

Intervention: somatropin (Drug); triptorelin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Belgian Study Group for Pediatric Endocrinology

Official(s) and/or principal investigator(s):
Raoul P Rooman, MD,PhD, Principal Investigator, Affiliation: BSGPE

Overall contact:
Raoul P Rooman, MD PhD, Phone: +32 3 821 4009, Email: raoul.rooman@uza.be


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.

Clinical Details

Official title: Efficacy and Safety of a 4 Year Combination Therapy of Growth Hormone and Gonadotropin- Releasing Hormone Agonist in Children With a Short Predicted Height.

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: height

Secondary outcome: bone density


Minimum age: 7 Years. Maximum age: 15 Years. Gender(s): Both.


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


- 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


Locations and Contacts

Raoul P Rooman, MD PhD, Phone: +32 3 821 4009, Email: raoul.rooman@uza.be

Hopital Universitaire Reine Fabiola (HUDERF), Brussels 1050, Belgium; Recruiting
Claudine Heinrichs, MD, PhD, Principal Investigator
Sylvie TENOUTASSE, MD, Principal Investigator
Cecile BRACHET, MD, Principal Investigator

Kinderziekenhuis UZ Brussel, Brussel 1090, Belgium; Recruiting
Jean De Schepper, MD PhD, Email: jean.deschepper@uzbrussel.be
Jean De Schepper, MD PhD, Principal Investigator

CHU ND-des Bruyères, Liege 4030, Belgium; Recruiting
Jean-Pierre Bourguignon, MD,PhD
Jean-Pierre Bourguignon, MD,PhD, Principal Investigator
Marie-Christine Lebrethon, MD,PhD, Principal Investigator
Anne-Simone PARENT, MD,PhD, Principal Investigator

Antwerp University Hospital, Edegem, Antwerpen 2650, Belgium; Recruiting
Annick France, MD, Phone: +3238215549, Email: annick.france@uza.be
Annick France, MD, Principal Investigator
Hilde Dotremont, MD, Sub-Investigator

Virga Jesse Ziekenhuis, Hasselt, Limburg 3000, Belgium; Recruiting
Guy Massa, MD PhD
Guy Massa, MD PhD, Principal Investigator

Kinderziekenhuis UGent, Gent, Oost Vlaanderen 9000, Belgium; Recruiting
Kathleen Dewaele, MD PhD
Martine Cools, MD PhD, Email: martine.cools@ugent.be
Kathleen Dewaele, MD, Principal Investigator
Martine COOLS, MD, PhD, Principal Investigator

Additional Information

Starting date: January 2008
Last updated: August 7, 2014

Page last updated: August 23, 2015

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