Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms (SPARE)
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Menopause Osteoporosis Osteopenia |
Dietary Supplement: Soy isoflavones Dietary Supplement: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Bone Sparing Effects of Soy Phytoestrogens in Menopause |
- Efficacy of a daily dose of purified soy isoflavone in preventing the rapid spinal bone loss occurring in early menopause [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Effectiveness in preventing hot flashes and changes in vaginal cytology, lipids, and binding globulins [ Time Frame: yearly over 2 years ] [ Designated as safety issue: No ]
- prevention of deterioration of general health-related quality of life and emotional health status generally occurring in early menopause [ Time Frame: over 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | June 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive a 200-mg dose of soy isoflavones daily over 2 years.
|
Dietary Supplement: Soy isoflavones
Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.
|
|
Placebo Comparator: 2
Participants will receive placebo daily over 2 years.
|
Dietary Supplement: Placebo
Placebo soy isoflavones
|
Detailed Description:
The risks of bone loss and osteoporosis increase significantly after menopause. Although hormone therapy (HT) can spare menopausal women from bone loss and other menopausal symptoms, Women's Health Initiative (WHI) findings indicate significant potential health risks associated with HT. This has prompted women to switch from HT to naturally occurring compounds similar to estrogen, such as those derived from soy, in the hope that estrogens from plant sources can provide benefits while sparing adverse effects caused by prescribed estrogens. However, the long-term efficacy and safety of plant estrogens are unknown. This study will evaluate the effectiveness of treatment using purified soy isoflavones, a dietary source of phytoestrogens, in preventing bone loss, menopausal symptoms, and other changes associated with estrogen deficiency in young menopausal women. The "Soy Phytoestrogens As Replacement Estrogen (SPARE)" study will provide a foundation of knowledge from which menopausal women and their doctors can begin to make more informed decisions regarding HT and other treatment options.
Enrollment into the study will occur over 3 years, with each participant taking part in the study for a total of 2 years. Participants will be randomly assigned to one of two groups; the first group will receive a 200 mg dose of soy isoflavones daily and the second group will receive placebo daily. There will be 10 study visits: screening, study entry, randomization at Month 1, six follow-up visits at Months 2, 4, 8, 12, 16, 20, and a final visit at the end of active participation at Month 24. At each study visit, participants will have blood drawn, provide urine samples, answer questionnaires, and have mammograms and bone density tests.
Eligibility| Ages Eligible for Study: | 45 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Silvina Levis, MD, University of Miami |
| ClinicalTrials.gov Identifier: | NCT00076050 History of Changes |
| Other Study ID Numbers: | R01 AR048932, NIAMS-114, SPARE |
| Study First Received: | January 13, 2004 |
| Last Updated: | April 8, 2009 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Bone Diseases, Metabolic Osteoporosis Bone Diseases Musculoskeletal Diseases Phytoestrogens Estrogens, Non-Steroidal |
Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013