Condition category
Signs and Symptoms
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
23/08/2006
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

Dose-response study

Study hypothesis

The change in biochemical parameters of bone and collagen metabolism during a short term Growth Hormone (GH) dose-response study predicts the long-term effect of GH on growth. Idiopathic short stature is partially explainable by an abnormal tissue responsiveness to GH and Insulin-like Growth Factor 1 (IGF-1). The hypotheses of this study are:
1. GH therapy in a dosage of 6 IU/mw/day administered before puberty increases height velocity, height in adolescence and final height.
2. GH administration affects puberty onset and its duration.
3. GH administration affects quality of life.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Idiopathic Short Stature (ISS)

Intervention

After randomisation, the control group did not receive treatment, and were followed yearly for growth and puberty assessment.
The treatment group underwent two three month periods of GH administration (1.5 IU/m^2/day, 3.0 IU/m^2/day) with three month washout periods in between. Thereafter 6 IU/m^2/day was given until the beginning of puberty.

Intervention type

Drug

Phase

Not Specified

Drug names

Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1).

Primary outcome measures

Height at stop of therapy (at onset of puberty) and final height.

Secondary outcome measures

1. Timing of onset of puberty
2. Duration of puberty
3. Relation between long-term growth response (dependent variable) and short-term growth response on various dosages and in vitro responsiveness of cultured skin fibroblasts to GH and IGF-1
4. Effect of GH therapy on quality of life

Overall trial start date

01/01/1994

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Height Standard Deviation Score (SDS) less than -2
2. Prepubertal
3. Aged between four to eight in females, or four to ten in males
4. GH response to provocation tests more than 20 mU/l
5. Normal sitting height:height ratio
6. Normal screening blood tests and urinanalysis

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40

Participant exclusion criteria

Any systemic disease during childhood that limits the growth potential or may interfere with the evaluation of the effectiveness of therapy.

Recruitment start date

01/01/1994

Recruitment end date

01/01/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center
Amsterdam
2300 RC
Netherlands

Sponsor information

Organisation

Pfizer B.V. (The Netherlands) (Pfizer Inc, New York, USA)

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

Research organisation

Funder name

Netherlands Organization for Scientific Research (NWO)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes