Prospective UK collaborative study of growth promoting treatment in Turner syndrome
| ISRCTN | ISRCTN50343149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50343149 |
| Secondary identifying numbers | Sponsor reference number: 99/CH/02 |
- Submission date
- 02/06/2010
- Registration date
- 08/07/2010
- Last edited
- 30/06/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Malcolm DC Donaldson
Scientific
Scientific
University of Glasgow Department of Child Health
Royal Hospital for Sick Children
Yorkhill
Glasgow
G3 8SJ
United Kingdom
Study information
| Study design | Multicentre randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Contact Emma-Jane Gault [EJ.Gault@clinmed.gla.ac.uk] (study research associate) for patient information (recruitment closed) |
| 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 |
| Study acronym | UK Turner Study |
| Study objectives | 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(s) | Scotland A Research Ethics Committee (formerly Multi-Centre Research Ethics Committee for Scotland) approved on the 25th of February 1999 (ref: 98/0/092) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 24/11/1999 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 13 Years |
| Sex | Female |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/11/1999 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
University of Glasgow Department of Child Health
Glasgow
G3 8SJ
United Kingdom
G3 8SJ
United Kingdom
Sponsor information
NHS Greater Glasgow & Clyde (UK)
Government
Government
Research and Development Central Office
NHS Greater Glasgow and Clyde
Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom
"ROR" |
https://ror.org/05kdz4d87 |
|---|
Funders
Funder type
Charity
1999 to 2004: Scottish Executive Chief Scientist Office (UK) (Ref. K/MRS/50/C2713)
No information available
2004 to present: British Society for Paediatric Endocrinology and Diabetes (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/04/2011 | Yes | No |
