Condition category
Not Applicable
Date applied
02/06/2010
Date assigned
08/07/2010
Last edited
30/06/2011
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 Malcolm DC Donaldson

ORCID ID

Contact details

University of Glasgow Department of Child Health
Royal Hospital for Sick Children
Yorkhill
Glasgow
G3 8SJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Sponsor reference number: 99/CH/02

Study information

Scientific title

Prospective UK collaborative study of growth promoting treatment in Turner syndrome; impact of a consistent dose of growth hormone therapy and benefit of combination treatment with oxandrolone, and early or late oestrogen induction in a group of girls with Turner syndrome

Acronym

UK Turner Study

Study hypothesis

In a group of girls with Turner syndrome receiving a standard dose of growth hormone therapy, what is the impact on final height of:
1. Adjunctive treatment with the anabolic steroid, oxandrolone, from 9 years of age and
2. The introduction of oestrogen therapy for pubertal induction at 12 versus 14 years of age?

Ethics approval

Scotland A Research Ethics Committee (formerly Multi-Centre Research Ethics Committee for Scotland) approved on the 25th of February 1999 (ref: 98/0/092)

Study design

Multicentre randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Contact Emma-Jane Gault [EJ.Gault@clinmed.gla.ac.uk] (study research associate) for patient information (recruitment closed)

Condition

Turner syndrome, which can be defined as the loss or abnormality of the second X chromosome in a phenotypic female

Intervention

Girls with Turner syndrome receiving a standard dose of growth hormone therapy are randomised to receive oxandrolone (0.05mg/kg/day; max. dose 2.5mg/day) or placebo from 9 years until final height. Participants are further randomised at 12 years of age to either begin pubertal induction (Ethinylestradiol Yr 1: 2mcg daily/Yr 2: 4mcg daily/Yr 3: 4 months each of 6, 8, 10 mcg daily) or to receive placebo for 2 years and begin pubertal induction (as above) at 14 years of age.
Participants are followed up until final height is attained.

Joint sponsor details:
University of Glasgow
Contact:
Paul G Ellis
Senior Contracts Manager
Research & Enterprise
University of Glasgow
10 The Square
Glasgow
G12 8QQ

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Final adult height (cm), defined as height velocity <1 cm/year and bone age ≤15.5 years.

Secondary outcome measures

1. Maximum height, i.e. the most recently available height
2. Age of attaining final height
3. Three summary growth parameters (size, tempo, velocity)

Overall trial start date

24/11/1999

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Girls with Turner syndrome, confirmed by karyotype
2. Age 7 - 13 years
3. Naive to growth hormone therapy or previous treatment within specified range (8.3-11.7mg/m2/week in 5-7 injections per week)
4. Naive to oxandrolone or oestrogen therapy
5. Open epiphyses
6. Free from major systemic illness likely to impact growth

Participant type

Patient

Age group

Child

Gender

Female

Target number of participants

100

Participant exclusion criteria

1. Age 0 - 6 years or 14+ years
2. Fused epiphyses
3. Chronic illness likely to impact growth
4. Social or psychological difficulties thought likely to result in serious impairment of concordance

Recruitment start date

24/11/1999

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Glasgow Department of Child Health
Glasgow
G3 8SJ
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow & Clyde (UK)

Sponsor details

Research and Development Central Office
NHS Greater Glasgow and Clyde
Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

1999 to 2004: Scottish Executive Chief Scientist Office (UK) (Ref. K/MRS/50/C2713)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

2004 to present: British Society for Paediatric Endocrinology and Diabetes (UK)

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/21493672

Publication citations

  1. Results

    Gault EJ, Perry RJ, Cole TJ, Casey S, Paterson WF, Hindmarsh PC, Betts P, Dunger DB, Donaldson MD, , Effect of oxandrolone and timing of pubertal induction on final height in Turner's syndrome: randomised, double blind, placebo controlled trial., BMJ, 2011, 342, d1980.

Additional files

Editorial Notes