Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms

NCT ID: NCT00076050

Last Updated: 2016-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2009-06-30

Brief 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.

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.

Conditions

Menopause; Osteoporosis; Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Participants will receive a 200-mg dose of soy isoflavones daily over 2 years.

Group Type: EXPERIMENTAL

Soy isoflavones

Intervention Type: DIETARY_SUPPLEMENT

Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.

2

Participants will receive placebo daily over 2 years.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo soy isoflavones

Interventions

Soy isoflavones

Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo soy isoflavones

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Silvina Levis, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvina Levis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami School of Medicine

Miami, Florida, United States

Countries

United States

References

Levis S, Strickman-Stein N, Ganjei-Azar P, Xu P, Doerge DR, Krischer J. Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial. Arch Intern Med. 2011 Aug 8;171(15):1363-9. doi: 10.1001/archinternmed.2011.330.

Reference Type: DERIVED

PMID: 21824950 (View on PubMed)

Other Identifiers

R01AR048932

Identifier Type: NIH

Identifier Source: secondary_id

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NIAMS-114

Identifier Type: -

Identifier Source: secondary_id

SPARE

Identifier Type: -

Identifier Source: secondary_id

R01AR048932

Identifier Type: NIH

Identifier Source: org_study_id

View Link