Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
24/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17284626

Publication citations

  1. 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.

Additional files

Editorial Notes