Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss

Baylor College of Medicine403 enrolled

Overview

The purpose of this study is to determine whether soy isoflavone supplementation is safe and effective to prevent bone loss in postmenopausal women.

Over-the-counter soy isoflavone supplement usage is becoming common among postmenopausal women. However, there is no documented scientific evidence of its long-term safety and efficacy in preventing osteoporosis. Our primary goal is to determine the safety, efficacy, and optimal dosage of isoflavone supplementation to reduce bone loss in postmenopausal women. The multi-state, multi-institutional design ensures that the study results are representative of postmenopausal women in the U.S. population. Confirming the skeletal benefits of soy isoflavones could translate into reduced healthcare costs related to osteoporosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

403

Conditions

Osteoporosis

Interventions

PlaceboDIETARY_SUPPLEMENT

Three pills per day for two years

Soy isoflavonesDIETARY_SUPPLEMENT

Three pills that delivered 80 mg of aglycone isoflavones per day for two years

Soy isoflavonesDIETARY_SUPPLEMENT

Three pills that delivered 120 mg aglycone isoflavones per day for two years

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Must be able to swallow the pills * No menses for 12 months * Blood follicle stimulating hormone great than 30 IU/mL * Lumbar spine bone mineral density t-score equal to or greater than -1.5 Exclusion Criteria: * Strict vegetarians * Current or recent smokers (within last five years) * Abnormal screening mammogram, Pap smear and blood chemistries * Clinical diagnosis of osteoporosis, spine and/or hip fracture, cancer, liver, kidney, gallbladder and heart disease * Clinical diagnosis of psychiatric disorder * Any allergic reactions to soy products * Current treatment with bisphosphonates, calcitonin, fluoride, corticosteroids, tamoxifen, raloxifene, HRT, premarin, farestron and letrozole * Current usage of black cohosh, blue cohosh, dong quai, Caltrate 600+Soy, Estroven, ginseng, Healthy Women, Natural Estrogen, Opti-Soy, PhytoFem, Probalance, Promensil, Remifemin, Rimostil and Trinovin

Locations (3)

University of California

Davis, California, United States

University of Georgia

Athens, Georgia, United States

Baylor College of Medicine

Houston, Texas, United States

Outcomes

Primary Outcomes

Bone mineral density

Time frame: One year and two years

Secondary Outcomes

Blood biochemical bone markers (osteocalcin, bone-specific alkaline phosphatase, cross-linked N-telopeptides of type 1 collagen)

Time frame: One year and two years

Data from ClinicalTrials.gov

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