Transition of care in women with Turner syndrome: Oxandrolone follow-up study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 133

Inclusion Criteria

Inclusion criteria are completion of the original TOS protocol at least 6 months prior to the study visit and age >=18 years. Main inclusion criteria of the original protocol (TOS) were: a) the diagnosis of TS should be confirmed by lymphocyte chromosomal analysis. Any chromosomal pattern which is known to be associated with TS characteristics is acceptable, except for evidence of a Y-chromosome on blood analysis. b) Chronological age between 2 and 15.99 years. c) Well-documented growth rate during the previous year. d) Bone-age lower than 12.0 years.

Exclusion Criteria

Exclusion criteria are: a) Patients who have participated in another experimental drug study within two months of entry into the present study. b) Malignant or severely disabling disease. c) Serious suspicion of psychiatric illnesses. d) Pregnancy or current fertility treatment.
Main exclusion criteria of the original protocol: a) Any endocrine or metabolic disorder, with the exception of thyroidal illnesses adequately treated and/or substituted. b) Growth failure due to disorders of urinary, cardiopulmonary, gastro-intestinal and nervous systems; nutritional/vitamin deficiencies and chondrodysplasias. c) Patients with hydrocephalus. d) Patients who have participated in another experimental drug study within two months of entry. e) Patients receiving any kind of drug that may interfere with GH therapy. f) Previous GH, sex hormone, or anabolic steroid treatment. g) Presence of any persistent abnormality at general pediatric and biochemical screening (including scoliosis, liver function tests, kidney function tests, electrtolytes, blood count, urine glucose, protein and sediment). h) Serious suspicion of psychosocial dwarfism (emotional deprivation) or psychiatric illnesses.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are: height, body proportions, body composition,<br /><br>symptoms and signs of virilization, glucose tolerance, lipid profile, cardiac<br /><br>conduction abnormalities, liver and thyroid function, (neuro)psychological<br /><br>function and quality of life. The effects of Ox are analyzed to a background of<br /><br>genotypic variation of the sex chromosomes and the growth hormone receptor.</p><br>

Secondary Outcome Measures