Osteoporosis Clinical Trial
— SPAREOfficial title:
Bone Sparing Effects of Soy Phytoestrogens in Menopause
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.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | June 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 60 Years |
Eligibility |
Inclusion Criteria - 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 Exclusion Criteria - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Miami School of Medicine | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of a daily dose of purified soy isoflavone in preventing the rapid spinal bone loss occurring in early menopause | 2 years | No | |
Secondary | Effectiveness in preventing hot flashes and changes in vaginal cytology, lipids, and binding globulins | yearly over 2 years | No | |
Secondary | prevention of deterioration of general health-related quality of life and emotional health status generally occurring in early menopause | over 2 years | No |
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