No registrations found.
ID
Source
Brief title
Health condition
girls with Turner syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
Final height.
Secondary outcome
Potential side effects (glucose intolerance; lowering of the voice);
psychosexual changes.
Background summary
Double-blind RCT on the effect of oxandrolone in two dosages (vs placebo) on long-term effects on growth, voice characteristics, psychosexual dedvelopment and carbohydrate metabolism.
Study objective
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.
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.
Nederlandse Groeistichting
Westzeedijk 106
Rotterdam 3016 AH
The Netherlands
+31 (0)10 2251533
Nederlandse Groeistichting
Westzeedijk 106
Rotterdam 3016 AH
The Netherlands
+31 (0)10 2251533
Inclusion criteria
Turner syndrome, confirmed by chromosomal analysis. 3 age ranges: 2.00-7.99 yrs, 8-11.99 yrs, 12.00-15.99 yrs.
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 steroidsor anabolic steroids;
6. Suspicion of emotional deprivation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL327 |
| NTR-old | NTR365 |
| Other | : N/A |
| ISRCTN | ISRCTN54336338 |