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A placebo controlled study on the effect of oxandrolone in combination with authentic biosynthetic human growth hormone and low-dose oestrogens on growth and metabolic parameters in girls with Turner's syndrome.


- candidate number1576
- NTR NumberNTR365
- ISRCTNISRCTN54336338
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleA placebo controlled study on the effect of oxandrolone in combination with authentic biosynthetic human growth hormone and low-dose oestrogens on growth and metabolic parameters in girls with Turner's syndrome.
- Scientific TitleA placebo controlled study on the effect of oxandrolone in combination with authentic biosynthetic human growth hormone and low-dose oestrogens on growth and metabolic parameters in girls with Turner's syndrome.
- ACRONYMOxandrolone study
- hypothesisAdding 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.
- Healt Condition(s) or Problem(s) studiedTurner syndrome
- Inclusion criteriaTurner syndrome, confirmed by chromosomal analysis. 3 age ranges: 2.00-7.99 yrs, 8-11.99 yrs, 12.00-15.99 yrs.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-1992
- planned closingdate1-jan-2012
- Target number of participants135
- InterventionsThree 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.
- Primary outcomeFinal height.
- Secondary outcomePotential side effects (glucose intolerance; lowering of the voice);
psychosexual changes.
- Timepoints
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Nederlandse Groeistichting
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.M. Wit
- Sponsor/Initiator Dutch Growth Foundation
- Funding
(Source(s) of Monetary or Material Support)
Pfizer, Lilly
- PublicationsN/A
- Brief summaryDouble-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.
- Main changes (audit trail)
- RECORD12-sep-2005 - 6-mrt-2006


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