Overview

This trial is active, not recruiting.

Conditions menopause, osteoporosis, osteopenia
Treatments soy isoflavones, placebo
Phase phase 3
Sponsor National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date September 2003
End date March 2009
Trial size 300 participants
Trial identifier NCT00076050, NIAMS-114, R01 AR048932, SPARE

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Participants will receive a 200-mg dose of soy isoflavones daily over 2 years.
soy isoflavones
Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.
(Placebo Comparator)
Participants will receive placebo daily over 2 years.
placebo
Placebo soy isoflavones

Primary Outcomes

Measure
Efficacy of a daily dose of purified soy isoflavone in preventing the rapid spinal bone loss occurring in early menopause
time frame: 2 years

Secondary Outcomes

Measure
Effectiveness in preventing hot flashes and changes in vaginal cytology, lipids, and binding globulins
time frame: yearly over 2 years
prevention of deterioration of general health-related quality of life and emotional health status generally occurring in early menopause
time frame: over 2 years

Eligibility Criteria

Female participants from 45 years up to 60 years old.

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

Additional Information

Official title Bone Sparing Effects of Soy Phytoestrogens in Menopause
Principal investigator Silvina Levis, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).