Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013546
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-03-20
Brief Title:
Hormone Replacement Therapy to Treat Turner Syndrome
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Turner Syndrome Hormone Replacement Therapy
Status:
COMPLETED
Status Verified Date:
2002-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effects of hormone replacement therapy on patients with Turner syndrome TS-a genetic disorder in females in which part or all of one X chromosome is missing Most girls and women with TS have underdeveloped ovaries-the female reproductive organs that produce the female sex hormones estrogen and progesterone and smaller amounts of the male sex hormone testosterone These hormones affect muscle and bone strength sex drive energy and an overall sense of well being Estrogen may also play a role in memory and mood and have a protective effect against heart disease Women with TS have a much higher risk of developing osteoporosis loss of bone density high blood pressure high cholesterol and diabetes than women without this disorder
Girls and women with Turner syndrome between the ages of 14 and 50 years may be eligible for this 2-year study Three months before beginning treatment all patients will wear an estrogen patch and take a progesterone tablet daily for 10 days each month They will then be randomly assigned to one of two treatment groups to compare the effects of estrogen alone with estrogen plus testosterone on bone strength muscle and fat mass and psychosocial well being Both groups will wear an estrogen patch and take oral progesterone One group will also wear a testosterone patch while the other group will wear a placebo patch a patch that does not contain any testosterone Neither study participants nor the doctors will know who is getting the testosterone until the study is complete Patients will undergo the following procedures before beginning treatment and at 6 12 and 24 months after starting treatment
Physical examination
DEXA scans dual energy X-ray absorptiometry to measure body composition and bone thickness Low radiation X-rays scan the whole body to measure fat muscle and bone mineral content
Magnetic resonance imaging MRI scan of the abdomen to measure the amount of fat around the internal organs The patient lies on a stretcher in a large tube surrounded by a magnetic field during the scanning The procedure uses a strong magnet and radio waves to produce the images
Heel ultrasound to measure bone thickness The heel is placed in a chamber and sound waves pass through it to produce images
Oral glucose tolerance test OGTT for diabetes and problems with carbohydrate metabolism The patient drinks a sugary substance A small amount of blood is drawn before taking the drink and four times afterwards
Blood and urine tests to measure blood counts liver and kidney function ovarian hormones growth factors thyroid function blood lipids bone strength markers and to test for pregnancy
Blood pressure measurements
Psychological testing for the effect of treatment on mood self-esteem quality of life social shyness anxiety and sexual function
Neurocognitive tests at first inpatient visit and 1 and 2 years after starting treatment to measure nonverbal memory and visual-perceptual abilities
During the hospital admissions patients will be given a metabolic diet that contains specific amounts of salt and carbohydrates to ensure accurate blood pressure and sugar metabolism measurements Patients will keep a record of their menstrual periods and physical activity throughout the treatment period
Girls and women with Turner syndrome between the ages of 14 and 50 years may be eligible for this 2-year study Three months before beginning treatment all patients will wear an estrogen patch and take a progesterone tablet daily for 10 days each month They will then be randomly assigned to one of two treatment groups to compare the effects of estrogen alone with estrogen plus testosterone on bone strength muscle and fat mass and psychosocial well being Both groups will wear an estrogen patch and take oral progesterone One group will also wear a testosterone patch while the other group will wear a placebo patch a patch that does not contain any testosterone Neither study participants nor the doctors will know who is getting the testosterone until the study is complete Patients will undergo the following procedures before beginning treatment and at 6 12 and 24 months after starting treatment
Physical examination
DEXA scans dual energy X-ray absorptiometry to measure body composition and bone thickness Low radiation X-rays scan the whole body to measure fat muscle and bone mineral content
Magnetic resonance imaging MRI scan of the abdomen to measure the amount of fat around the internal organs The patient lies on a stretcher in a large tube surrounded by a magnetic field during the scanning The procedure uses a strong magnet and radio waves to produce the images
Heel ultrasound to measure bone thickness The heel is placed in a chamber and sound waves pass through it to produce images
Oral glucose tolerance test OGTT for diabetes and problems with carbohydrate metabolism The patient drinks a sugary substance A small amount of blood is drawn before taking the drink and four times afterwards
Blood and urine tests to measure blood counts liver and kidney function ovarian hormones growth factors thyroid function blood lipids bone strength markers and to test for pregnancy
Blood pressure measurements
Psychological testing for the effect of treatment on mood self-esteem quality of life social shyness anxiety and sexual function
Neurocognitive tests at first inpatient visit and 1 and 2 years after starting treatment to measure nonverbal memory and visual-perceptual abilities
During the hospital admissions patients will be given a metabolic diet that contains specific amounts of salt and carbohydrates to ensure accurate blood pressure and sugar metabolism measurements Patients will keep a record of their menstrual periods and physical activity throughout the treatment period
Detailed Description:
Turner Syndrome TS is characterized by ovarian dysgenesis and short stature resulting from the partial or complete deletion of one X-chromosome Adults with TS have excessive rates of osteoporosis hypertension dyslipidemia and diabetes mellitus and may have increased morbidity and mortality as a result These problems of adults with TS may be secondary to deficiency of ovarian hormones or may result from halpo-insufficiency for as yet unknown X-chromosome genes There have been no prospective controlled studies of the effects of hormone replacement therapy HRT in TS but available data suggest that conventional oral HRT designed for postmenopausal women may not prevent osteoporosis and may aggravate hypertension in this disorder Of note girls and women with TS are deficient in ovarian androgens as well as estrogen and have reduced muscle mass which may contribute to osteoporosis and insulin resistance In addition reduced androgens may contribute to the impairment of self esteem and social interactions suffered by many with TS In this study two different hormone regimens for TS will be compared in a randomized placebo-controlled double-blind design Both groups will receive transdermal estradiol E2 100 mcgday with cyclic progesterone one group will receive a physiological dose of testosterone T by transdermal patch while the other group will receive a placebo patch The treatment duration is 2 years Major outcome parameters include predicted improvements in bone mineral density body composition and psychosocial well-being Essential information will be collected on the effects of hormone treatments on insulin sensitivity and blood pressure in TS This study will help to optimize hormone replacement treatment for women with TS and to clarify which of the metabolic problems of TS are secondary to ovarian hormone deficiency and which are due to genetic factors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-CH-0114 | None | None | None |