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
Protocol serial number	N/A
Sponsor	Pfizer B.V. (Netherlands) (Pfizer Inc, New York)
Funders	University Medical Centre Utrecht (UMCU) (Netherlands), Netherlands Organisation for Scientific Research (NWO) (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Multicentre randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	GH+GnRHa study
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	Final height SDS minus initial height SDS
Key secondary outcome measure(s)	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
Completion date	01/07/2006

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	40
Key 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
Key exclusion criteria	Disorders or medication influencing growth
Date of first enrolment	01/10/1993
Date of final enrolment	01/07/2006

Leiden University Medical Center

Amsterdam
2300 RC
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

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