Status:
COMPLETED
Soy and Isoflavones Effect on Bone
Lead Sponsor:
United States Department of Agriculture (USDA)
Collaborating Sponsors:
University of Connecticut
Conditions:
Osteoporosis
Eligibility:
FEMALE
65+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to test the effect of 1 year of added dietary soy protein and/or soy isoflavones on bone mineral density in late postmenopausal women.
Detailed Description
Although soy foods contain several components (isoflavones and amino acids) that could potentially have positive effects on bone health, there are few long term, large, clinical trials using soy as a ...
Eligibility Criteria
Inclusion
- Postmenopausal women 65 years old or older
- Able to travel to the clinical sites for follow-up visits
Exclusion
- History of disease that may affect bone metabolism (including Paget's disease, primary hyperparathyroidism, osteomalacia, untreated hyperthyroidism, or multiple myeloma)
- Cancer of any kind (except basal or squamous cell of skin) in past 5 years
- Use of any of the following medications within the past 2 years: calcitonin, calcitriol, heparin, phenytoin, phenobarbital
- Use at any time of bisphosphonates, long-term corticosteroids (over 6 months), methotrexate, or fluoride
- Estimated creatinine clearance less than 50 ml/min
- History of chronic liver disease or evidence of liver disease on screening
- History of hip fracture
- Known vertebral fracture within the past year
- Vegans
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00668447
Start Date
November 1 2001
End Date
June 1 2005
Last Update
April 29 2008
Active Locations (1)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030