Turner Syndrome Clinical Trial
Official title:
The Growth of Genitalia Interna and the Bone Mineralization Under Hormonal Replacement Therapy and the Presence of Aortic Root Dilatation in Girls With Turner Syndrome
The purpose of this study is to examine whether a larger dosage of estrogen than the one
used today will secure the development of a normal sized uterus and increase the strength of
the bones in girls and young women with Turner syndrome.
The purpose is also to evaluate whether aortic dilatation is present in this group of
patients, and if the estrogen dosage will influence the emotional well-being and self-esteem
of the patients.
Turner syndrome is a common chromosomal disorder with only one X-chromosome or partial
deletions in one X-chromosome in all or some of the cell-lines in the body. Appr. 18
girls/year are being born with the syndrome in Denmark. The syndrome is mostly known for
reduced final height and the lack of pubertal development with infertility, but it is also
known for diseases influencing other parts of the body like the heart with the risk of
development of aortic dilatation and subsequently dissection with the risk of rupture,
profuse bleeding and sudden death. Reduced bone strength and increased risk of bone fracture
are also features of the syndrome. Treatment with growth hormone and female sex-hormones are
well-established treatments.
Girls and young women with Turner syndrome ages 10 to 21 years will participate. The girls
ages 15 to 21 years will randomly and double blindly receive treatment with either 2 mg or 4
mg estrogen for 5 years. Yearly examinations with blood tests, physical examinations,
questionnaires, ultrasound and MR-scan of the internal female genitalia, DEXA-scan of the
bones and MR-scan of the heart will be performed.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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