A study on the efficacy of the combination of growth hormone (GH) and gonadotropin releasing hormone analogues (GnRHa) on adult height in children with idiopathic short stature

ISRCTN ISRCTN82161629
DOI https://doi.org/10.1186/ISRCTN82161629
Secondary identifying numbers N/A
Submission date
19/12/2005
Registration date
19/12/2005
Last edited
24/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof J.M. Wit
Scientific

Leiden University Medical Center
Department of Pediatrics
P.O. Box 9600
Amsterdam
2300 RC
Netherlands

Phone +31 (0)71 5262824
Email j.m.wit@lumc.nl

Study information

Study designMulticentre randomised open label active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymGH+GnRHa study
Study objectivesA 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
Health condition(s) or problem(s) studiedSmall for Gestational Age (SGA), children with persistent short stature
InterventionDaily 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 typeOther
Primary outcome measureFinal height SDS minus initial height SDS
Secondary outcome measures1. 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 date01/10/1993
Completion date01/07/2006

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants40
Key inclusion criteria40 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
Key exclusion criteriaDisorders or medication influencing growth
Date of first enrolment01/10/1993
Date of final enrolment01/07/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Center
Amsterdam
2300 RC
Netherlands

Sponsor information

Pfizer B.V. (Netherlands) (Pfizer Inc, New York)
Not defined

P.O. Box 37
Capelle a/d IJssel
2900 AA
Netherlands

Phone +31 (0)10 4064200
Email sigrid.van.den.broek@pfizer.com
ROR logo "ROR" https://ror.org/02bzf1224

Funders

Funder type

Hospital/treatment centre

University Medical Centre Utrecht (UMCU) (Netherlands)

No information available

Netherlands Organisation for Scientific Research (NWO) (Netherlands)
Government organisation / National government
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
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2007 Yes No