Bone Response to Soy Isoflavones in Women

Completed · Phase 2

Conditions studied: Osteopenia, Osteoporosis

In brief

This study will provide valuable data on whether soy isoflavones impact bone loss in postmenopausal women. The study will help clarify potential mechanisms and contribute to our understanding of isoflavones as an alternative to traditional hormone therapy.

Key facts

Study ID

NCT00043745

Run by

Iowa State University

People needed

224

Starts

2003-03-01

Last updated by the study team

2013-02-07

Who can join

Age: 45 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Early postmenopausal (i.e., no menses during past 12 months) women, with an upper limit of 10 years since their last cycle
• Natural menopause (i.e., no hysterectomies or oophorectomies)
• Body mass index (BMI) > 20 and < 30

You may not qualify if…

• Current or previous (within 12 months) use of hormone replacement therapy, hormonal contraceptives, estrogens, or progestogens
• Current use of pharmacologic agents, such as selective estrogen-receptor modulators (SERMs) (e.g., raloxifene or tamoxifen) or anti-resorptive agents (e.g., alendronate or calcitonin), herbal therapies that may have estrogenic effects (e.g., herbimycin, tryphostins), or cigarettes
• Strict vegans (but will include lacto-ovo-, lacto-, and ovo-vegetarians)
• Metabolic bone disease, renal disease, history of urolithiasis, cancer, cardiovascular disease, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease, or other chronic diseases
• First-degree relative with breast cancer
• Lumbar spine BMD >= -1.5 standard deviations (SD) below mean (high-risk for osteoporosis) and BMD >= +1.0 SD above mean

Where it is running

• USDA/ARS/WHNRC University of California-Davis — Davis, California, United States
• Iowa State University — Ames, Iowa, United States

Full record on ClinicalTrials.gov

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