Soy and Isoflavones Effect on Bone

Completed · Phase 4 · Has a placebo group

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00668447

Run by

United States Department of Agriculture (USDA)

People needed

97

Starts

2001-11-01

Expected to finish

2005-06-01

Last updated by the study team

2008-04-29

Who can join

Age: 65 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Postmenopausal women 65 years old or older
• Able to travel to the clinical sites for follow-up visits

You may not qualify if…

• 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

Where it is running

• University of Connecticut Health Center — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

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