Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss

Completed · Not applicable · Has a placebo group

Conditions studied: Osteoporosis

In brief

The purpose of this study is to determine whether soy isoflavone supplementation is safe and effective to prevent bone loss in postmenopausal women.

Key facts

Study ID

NCT00665860

Run by

Baylor College of Medicine

People needed

403

Starts

2001-04-01

Expected to finish

2006-06-01

Last updated by the study team

2020-11-27

Who can join

Age: 40 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California — Davis, California, United States
• University of Georgia — Athens, Georgia, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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