Status:
COMPLETED
Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
University of California
Kaiser Foundation Research Institute
Conditions:
Osteoporosis
Eligibility:
FEMALE
40-60 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether soy isoflavone supplementation is safe and effective to prevent bone loss in postmenopausal women.
Detailed Description
Over-the-counter soy isoflavone supplement usage is becoming common among postmenopausal women. However, there is no documented scientific evidence of its long-term safety and efficacy in preventing o...
Eligibility Criteria
Inclusion
- Must be able to swallow the pills
- No menses for 12 months
- Blood follicle stimulating hormone great than 30 IU/mL
- Lumbar spine bone mineral density t-score equal to or greater than -1.5
Exclusion
- Strict vegetarians
- Current or recent smokers (within last five years)
- Abnormal screening mammogram, Pap smear and blood chemistries
- Clinical diagnosis of osteoporosis, spine and/or hip fracture, cancer, liver, kidney, gallbladder and heart disease
- Clinical diagnosis of psychiatric disorder
- Any allergic reactions to soy products
- Current treatment with bisphosphonates, calcitonin, fluoride, corticosteroids, tamoxifen, raloxifene, HRT, premarin, farestron and letrozole
- Current usage of black cohosh, blue cohosh, dong quai, Caltrate 600+Soy, Estroven, ginseng, Healthy Women, Natural Estrogen, Opti-Soy, PhytoFem, Probalance, Promensil, Remifemin, Rimostil and Trinovin
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT00665860
Start Date
April 1 2001
End Date
June 1 2006
Last Update
November 27 2020
Active Locations (3)
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1
University of California
Davis, California, United States, 95616
2
University of Georgia
Athens, Georgia, United States, 30602
3
Baylor College of Medicine
Houston, Texas, United States, 77030