Actively Recruiting
Role of Estrogen on Skeletal Outcomes in FHA
Led by University of Virginia · Updated on 2026-04-17
150
Participants Needed
2
Research Sites
243 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to assess whether the natural form of estrogen (17-beta estradiol) given as a patch so that it is absorbed through your skin, is better at improving bone strength over 1 year than natural estrogen (17-beta estradiol) taken by mouth, or a synthetic form oestrogen (ethinyl estradiol) given as a patch that also provides birth control. Participants will: 1. Take estrogen for 1 year either (i) in its natural form as a patch twice a week (and progesterone by mouth for 12 days of each month), or (ii) in its natural form as a pill daily (and progesterone by mouth for 12 days of each month), or (iii) in a synthetic form as a birth control patch weekly for 3 weeks with 1 week off the patch. You will not be able to choose which form of estrogen you will receive as this will be assigned to you based on a pre-existing randomization sequence (like the flip of a coin) 2. Take provided calcium and vitamin D supplements 3. Attend 4 study visits over 12 months with two at the beginning and then every 6 months that include: * History and Physical Exams * Lab Work * Imaging studies * Questionnaires * Dietary recalls
CONDITIONS
Official Title
Role of Estrogen on Skeletal Outcomes in FHA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 14 to 30 years, skeletally mature with bone age 14 years or older
- Use of effective non-hormonal contraception or progestin-releasing intrauterine device during the study if sexually active
- Negative pregnancy test and specific normal lab values including TSH, prolactin, potassium, ALT, and LDL
- Patients with treated hypothyroidism with stable TSH levels for at least one month before the study
- Fewer than 3 menstrual periods in the past 6 months
You will not qualify if you...
- Diseases other than FHA that affect bone, including untreated thyroid dysfunction, Cushing's disease, renal failure, and diabetes
- Untreated or unstable hypothyroidism with abnormal TSH levels
- Use of medications affecting bone metabolism within 3 months before the study (except calcium and vitamin D)
- Substance use disorder or current heavy smoking (>10 cigarettes/day)
- Pregnant, breastfeeding, or planning pregnancy within 12 months after treatment
- Hypertension or use of blood pressure medications
- Other causes of oligo-amenorrhea such as PCOS or premature ovarian insufficiency
- Known allergy or contraindications to study medications including high risk for blood clots or estrogen-sensitive cancers
- Body mass index (BMI) of 25 kg/m2 or higher
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
2
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
M
Madhusmita Misra, MD, MPH
CONTACT
D
Delaney Simchuk, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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