|- candidate number||2137|
|- NTR Number||NTR708|
|- ISRCTN||Incomplete info for ISRCTN|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-jun-2006|
|- Secondary IDs||N/A |
|- Public Title||A placebo controlled study on the effect of oxandrolone, growth hormone and low-dose estrogens on growth, psychological parameters, and characteristics of the voice
in girls with Turner's syndrome.|
|- Scientific Title||A placebo controlled study on the effect of oxandrolone in combination with authentic biosynthetic human growth hormone and low-dose estrogens on growth and metabolic parameters in girls with Turner's syndrome.|
|- ACRONYM||Dutch Turner-oxandrolone study|
|- hypothesis||The study aims to assess the efficacy (in terms of growth response over the years of treatment, including final height) and safety of a treatment regimen consisting of:|
1. Authentic biosynthetic growth hormone (GH) in a dosage of 4 IU/m2/day between the age of 2 and 7.99 years;
2. Oxandrolone at a dose of either 0.06 or 0.03 mg/kg b.w./day per os or placebo from the age of 8 years on (when the GH-treated girls completed a full number of years of GH-treatment) until the age that final height has been achieved;
3. Low dose estrogen treatment from the age of 12 years on (when a full number of years of oxandrolon-treatment has been fulfilled) until the age that final height has been achieved.
The aim of the phoniatric part of the study is to recognize and, in case of occurrence, quantify virilizing effects on the voice during oxandrolone therapy.
The psychologic part of the study aims to investigate the psychological effects of oxandrolone treatment, especially in the fields of mood, activity level, aggression and sexuality.
|- Healt Condition(s) or Problem(s) studied||Turner syndrome|
|- Inclusion criteria||1. The diagnosis Turner syndrome should be confirmed by lymphocyte chromosomal analysis;|
2. Chronological age between 2 and 15.99 years;
3. Well documented growth rate during the previous year;
4. Bone age (TW-RUS) lower than 12.0 years.
|- Exclusion criteria||1. Any endocrine or metabolic disorder, such as diabetes mellitus, diabetes insipidus or inborn errors of metabolism, with the exeption of thyroidal illnesses adequately treated/substituted;|
2. Growth failure due to disorders of urinary, cardiopulmonary, gastro-intestinal and nervous system; nutritional/vitamin deficiencies and chondrodysplasias;
3. Patients with hydrocephalus;
4. Patients who have participated in other experimental drug study within 2 months of entry into the present study;
5. Patients receiving any kind of drug that may interfere with GH-therapy;
6. Previous GH, sex hormone or anabolic steroid treatment;
7. Presence of persistent abnormality at general pediatric and biochemical screening;
8. Serious suspicion of emotional deprivation or psychiatric illnesses.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-dec-1991|
|- planned closingdate||1-sep-2010|
|- Target number of participants||133|
|- Interventions||All patients will receive biosynthetic GH by means of a pen-injection system. The GH-injections will be given at a dose of 4 IU/m2 b.s./day until final heiht. The GH preparations used are Genotropin® originally manufactured by Kabi Vitrum, now Pfizer, and Humatrope®, manufactured by Eli Lilly.
From the age of 8 to 9 years the patients will be divided in three treatment regimens additional to the GH therapy:|
Group A: placebo;
Group B: 0.03 mg oxandrolone/kg b.w./day per os;
Group C: 0.06 mg oxandrolone/kg b.w./day per os.
At the age of 12-13 years the girls will also receive low-dose estrogens: ethinyl estradiol 0.05 µg/kg/day per os (in the morning) or 17-ß-estradiol in an equivalent dosage.
|- Primary outcome||The effects of the various treatment regimens will be analysed in terms of:|
1. Clinical, auxological and biochemical parameters;
2. (Changes in) characteristics of the voice;
3. Psychological parameters.
|- Secondary outcome||To assess the effects of oxandrolone on: |
1. Carbohydrate metabolism;
2. Abnormalities of liver function;
3. Thyroxine binding globulin levels;
4. Masculinizing effects.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. G.R.J. Zandwijken|
|- CONTACT for SCIENTIFIC QUERIES||MD. G.R.J. Zandwijken|
|- Sponsor/Initiator ||Dutch Growth Foundation|
(Source(s) of Monetary or Material Support)
|Pfizer, Eli Lilly Nederland B.V.|
|- Brief summary||The study aims to assess the efficacy and safety of oxandrolone at a dose of either 0.06 or 0.03 mg/kg b.w./day per os versus placebo in girls with Turner syndrome who are also treated with daily subcutaneous injections of 4 IU/m2 b.s. of biosynthetic GH. Low-dose estrogens are added from the age of 12-13 years onward. |
A phoniatric part of the study will investigate whether oxandrolone therapy has virilizing effects on the voice and if so, to quantify these effect.
The psychological part aims to investigate psychological effects of treatment with oxandrolone.
|- Main changes (audit trail)|
|- RECORD||16-jun-2006 - 23-apr-2008|