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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21493672
Publication citations
-
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.