Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms

Completed · Phase 3 · Has a placebo group

Conditions studied: Menopause, Osteoporosis, Osteopenia

In brief

The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women who have recently gone through menopause. Study hypothesis: Tablets of high-dose, purified soy phytoestrogens spare the normally occurring spinal bone loss and improve biological and other emotional changes of menopause.

Key facts

Study ID

NCT00076050

Run by

University of Miami

People needed

248

Starts

2003-09-01

Expected to finish

2009-06-01

Last updated by the study team

2016-12-06

Who can join

Age: 45 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Absence of menstrual period for 12 months but not more than 5 years, or absence of menstrual period for 6 to 12 months and follicle stimulating factor (FSH) greater than 40 IU/L

You may not qualify if…

• Treatment with estrogens, progesterone, raloxifene, or tamoxifen
• Treatment with bisphosphonates, calcitonin, fluoride, or systemic corticosteroids
• Use of soy/herbal supplements, including DHEA, within 3 months prior to study entry
• Use of antibiotics in the month prior to study entry
• Use of prescription medication to treat hot flashes
• Chemical menopause, including post-chemotherapy
• Hyperthyroidism
• Hypothyroidism
• Uncontrolled diabetes
• Malabsorption syndromes or other chronic diseases
• Body mass index (BMI) less than 20 or greater than 32
• Bone mineral density (BMD) T-score below -2.0 in lumbar spine or femoral neck

Where it is running

• University of Miami School of Medicine — Miami, Florida, United States

Full record on ClinicalTrials.gov

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