Contact information
Type
Scientific
Primary contact
Prof J.M. Wit
ORCID ID
Contact details
Leiden University Medical Center
Department of Pediatrics
P.O. Box 9600
Amsterdam
2300 RC
Netherlands
+31 (0)71 5262824
j.m.wit@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
GH+GnRHa study
Study hypothesis
A combined treatment of GH and GnRHa for 3 years in short adolescents with relatively early puberty leads to final height gain.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Small for Gestational Age (SGA), children with persistent short stature
Intervention
Daily injections of Growth Hormone (GH) and monthly injections with GnRHa (Decapeptyl) for 3 years.
Regular controls at the clinic, blood investigations for effect and safety parameters, yearly X-rays of the hand, and yearly psychological assessment.
At final height, growth, psychological assessment, bone mineral density.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Final height SDS minus initial height SDS
Secondary outcome measures
1. Final height SDS
2. Final height SDS minus initial height SDS
3. Final height SDS minus target height
4. Body mass index
5. Bone mineral density
6. Quality of life
Overall trial start date
01/10/1993
Overall trial end date
01/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
40 adolescents in early puberty, with a height <-2 Standard Deviation Score (SDS) or with a height SDS between -1 and -2, but a predicted adult height SDS <-2
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
40
Participant exclusion criteria
Disorders or medication influencing growth
Recruitment start date
01/10/1993
Recruitment end date
01/07/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Amsterdam
2300 RC
Netherlands
Sponsor information
Organisation
Pfizer B.V. (Netherlands) (Pfizer Inc, New York)
Sponsor details
P.O. Box 37
Capelle a/d IJssel
2900 AA
Netherlands
+31 (0)10 4064200
sigrid.van.den.broek@pfizer.com
Sponsor type
Not defined
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Centre Utrecht (UMCU) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Netherlands Organisation for Scientific Research (NWO) (Netherlands)
Alternative name(s)
Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation, NWO
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17284626
Publication citations
-
Results
van Gool SA, Kamp GA, Visser-van Balen H, Mul D, Waelkens JJ, Jansen M, Verhoeven-Wind L, Delemarre-van de Waal HA, de Muinck Keizer-Schrama SM, Leusink G, Roos JC, Wit JM, Final height outcome after three years of growth hormone and gonadotropin-releasing hormone agonist treatment in short adolescents with relatively early puberty., J. Clin. Endocrinol. Metab., 2007, 92, 4, 1402-1408, doi: 10.1210/jc.2006-2272.