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

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 133 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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 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.

发起方

niversitair Medisch Centrum Sint Radboud