Condition category
Not Applicable
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
10/01/2012
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

Dr - Nederlandse Groeistichting

ORCID ID

Contact details

Westzeedijk 106
Rotterdam
3016 AH
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Oxandrolone study

Study hypothesis

Adding oxandrolone to the standard treatment of GH (in adolescence combined with oestrogens) increases growth velocity and final height. Adding oxandrolone does not lead to untoward side effects e.g. on voice characteristics.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised double blind placebo 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

Turner syndrome

Intervention

Three arm study:
1. GH alone (plus oestrogens in adolescence)
2. Idem plus low-dose oxandrolone (0.03 mg/kg body weight/day)
3. Idem plus moderate-dose oxandrolone (0.06 mg/kg/day)

Intervention type

Drug

Phase

Not Specified

Drug names

Oxandrolone

Primary outcome measures

Final height.

Secondary outcome measures

1. Potential side effects (glucose intolerance; lowering of the voice)
2. Psychosexual changes

Overall trial start date

01/01/1992

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Turner syndrome, confirmed by chromosomal analysis. 3 age ranges: 2.00-7.99 years, 8-11.99 years, 12.00-15.99 years.

Participant type

Patient

Age group

Child

Gender

Female

Target number of participants

135

Participant exclusion criteria

1. Any other disorder that may affect growth
2. Hydrocephalus
3. Other experimental drug study
4. Drugs that may interfere with GH
5. Previous treatment with GH or sex steroids or anabolic steroids
6. Suspicion of emotional deprivation

Recruitment start date

01/01/1992

Recruitment end date

01/01/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

Westzeedijk 106
Rotterdam
3016 AH
Netherlands

Sponsor information

Organisation

Dutch Growth Foundation (Netherlands)

Sponsor details

Westzeedijk 106
Rotterdam
3016 AH
Netherlands

Sponsor type

Charity

Website

Funders

Funder type

Industry

Funder name

Pfizer (Netherlands)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Lilly (Netherlands)

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20971614

Publication citations

  1. Results

    Menke LA, Sas TC, van Koningsbrugge SH, de Ridder MA, Zandwijken GR, Boersma B, Dejonckere PH, de Muinck Keizer-Schrama SM, Otten BJ, Wit JM, The effect of oxandrolone on voice frequency in growth hormone-treated girls with Turner syndrome., J Voice, 2011, 25, 5, 602-610, doi: 10.1016/j.jvoice.2010.06.002.

Additional files

Editorial Notes