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Prospective UK collaborative study of growth promoting treatment in Turner syndrome

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50343149
Enrollment
100
Registered
2010-07-08
Start date
1999-11-24
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Turner syndrome, which can be defined as the loss or abnormality of the second X chromosome in a phenotypic female Not Applicable Turner's syndrome

Interventions

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: 4mc

Sponsors

NHS Greater Glasgow & Clyde (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026