A placebo controlled study on the effect of oxandrolone in combination with authentic biosynthetic human growth hormone (GH) and low-dose oestrogens on growth and metabolic parameters in girls with Turner's syndrome
| ISRCTN | ISRCTN54336338 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54336338 |
| Protocol serial number | N/A |
| Sponsor | Dutch Growth Foundation (Netherlands) |
| Funders | Pfizer (Netherlands), Lilly (Netherlands) |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 10/01/2012
- 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 - Nederlandse Groeistichting
Scientific
Scientific
Westzeedijk 106
Rotterdam
3016 AH
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised double blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Oxandrolone study |
| Study objectives | Adding oxandrolone to the standard treatment of GH (in adolescence combined with oestrogens) increases growth velocity and final height. Adding oxandrolone does not lead to untoward side effects e.g. on voice characteristics. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Turner syndrome |
| Intervention | Three arm study: 1. GH alone (plus oestrogens in adolescence) 2. Idem plus low-dose oxandrolone (0.03 mg/kg body weight/day) 3. Idem plus moderate-dose oxandrolone (0.06 mg/kg/day) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oxandrolone |
| Primary outcome measure(s) |
Final height. |
| Key secondary outcome measure(s) |
1. Potential side effects (glucose intolerance; lowering of the voice) |
| Completion date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 16 Years |
| Sex | Female |
| Target sample size at registration | 135 |
| Key inclusion criteria | Turner syndrome, confirmed by chromosomal analysis. 3 age ranges: 2.00-7.99 years, 8-11.99 years, 12.00-15.99 years. |
| Key exclusion criteria | 1. Any other disorder that may affect growth 2. Hydrocephalus 3. Other experimental drug study 4. Drugs that may interfere with GH 5. Previous treatment with GH or sex steroids or anabolic steroids 6. Suspicion of emotional deprivation |
| Date of first enrolment | 01/01/1992 |
| Date of final enrolment | 01/01/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Westzeedijk 106
Rotterdam
3016 AH
Netherlands
3016 AH
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | Yes | No |
