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ISRCTN
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ISRCTN50343149
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ClinicalTrials.gov identifier
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Public title
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Prospective UK collaborative study of growth promoting treatment in Turner syndrome
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Scientific title
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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
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Acronym
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UK Turner Study
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Serial number at source
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Sponsor reference number: 99/CH/02
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Study hypothesis
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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?
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Lay summary
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Not provided at time of registration
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Ethics approval
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Scotland A Research Ethics Committee (formerly Multi-Centre Research Ethics Committee for Scotland) approved on the 25th of February 1999 (ref: 98/0/092)
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Study design
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Multicentre randomised double blind placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Turner syndrome, which can be defined as the loss or abnormality of the second X chromosome in a phenotypic female
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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24/11/1999
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Anticipated end date
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31/12/2011
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Status of trial
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Completed |
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Patient information material
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Contact Emma-Jane Gault [EJ.Gault@clinmed.gla.ac.uk] (study research associate) for patient information (recruitment closed)
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Target number of participants
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100
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Interventions
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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
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Primary outcome measure(s)
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Final adult height (cm), defined as height velocity <1 cm/year and bone age ≤15.5 years.
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Secondary outcome measure(s)
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1. Maximum height, i.e. the most recently available height
2. Age of attaining final height
3. Three summary growth parameters (size, tempo, velocity)
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Sources of funding
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1. 1999 to 2004: Scottish Executive Chief Scientist Office (UK) (Ref. K/MRS/50/C2713)
2. 2004 to present: British Society for Paediatric Endocrinology and Diabetes (UK)
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Trial website
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21493672
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Contact name
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Dr
Malcolm DC
Donaldson
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Address
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University of Glasgow Department of Child Health
Royal Hospital for Sick Children
Yorkhill
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City/town
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Glasgow
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Zip/Postcode
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G3 8SJ
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Country
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United Kingdom
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Sponsor
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NHS Greater Glasgow & Clyde (UK)
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Address
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Research and Development Central Office
NHS Greater Glasgow and Clyde
Western Infirmary
38 Church Street
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City/town
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Glasgow
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Zip/Postcode
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G11 6NT
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Country
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United Kingdom
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Date applied
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02/06/2010
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Last edited
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30/06/2011
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Date ISRCTN assigned
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08/07/2010
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