Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
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 study start date
01/10/1993
Overall study 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(s)
Patient
Age group
Child
Sex
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
Study 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
ROR
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, Dutch Research Council (Nederlandse Organisatie voor Wetenschappelijk Onderzoek), NWO:Nederlandse Organisatie voor Wetenschappelijk Onderzoek, Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO), Dutch Research Council, Dutch Research Council, Netherlands, NWO
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2007 | Yes | No |