Status:
COMPLETED
Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Menopause
Osteoporosis
Eligibility:
FEMALE
45-60 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women who have recent...
Detailed Description
The risks of bone loss and osteoporosis increase significantly after menopause. Although hormone therapy (HT) can spare menopausal women from bone loss and other menopausal symptoms, Women's Health In...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Absence of menstrual period for 12 months but not more than 5 years, or absence of menstrual period for 6 to 12 months and follicle stimulating factor (FSH) greater than 40 IU/L
- Exclusion Criteria
- Treatment with estrogens, progesterone, raloxifene, or tamoxifen
- Treatment with bisphosphonates, calcitonin, fluoride, or systemic corticosteroids
- Use of soy/herbal supplements, including DHEA, within 3 months prior to study entry
- Use of antibiotics in the month prior to study entry
- Use of prescription medication to treat hot flashes
- Chemical menopause, including post-chemotherapy
- Hyperthyroidism
- Hypothyroidism
- Uncontrolled diabetes
- Malabsorption syndromes or other chronic diseases
- Body mass index (BMI) less than 20 or greater than 32
- Bone mineral density (BMD) T-score below -2.0 in lumbar spine or femoral neck
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00076050
Start Date
September 1 2003
End Date
June 1 2009
Last Update
December 6 2016
Active Locations (1)
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1
University of Miami School of Medicine
Miami, Florida, United States, 33136