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.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29682

Enrollment

133

Registered

2006-06-16

Start date

1991-12-17

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Girls with Turner syndrome.

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®

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

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To assess the effects of oxandrolone on: 1. Carbohydrate metabolism; 2. Abnormalities of liver function; 3. Thyroxine binding globulin levels; 4. Masculinizing effects.	—

Contacts

Public ContactG.R.J. Zandwijken

Dutch Growth Foundation, Westzeedijk 106

g.zandwijken@groeistichting.nl+31 (0)10 2251533

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)