Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss

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

Detailed Description
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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.

Official Title
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Safety, Efficacy, and Optimal Dosage of Soy Isoflavones to Prevent Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Soy isoflavones
* Dietary Supplement: Soy isoflavones


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Dietary Supplement: Placebo<br>* Three pills per day for two years<br>|
| Active Comparator: 2<br> | Dietary Supplement: Soy isoflavones<br>* Three pills that delivered 80 mg of aglycone isoflavones per day for two years<br>* Other names: Soy germ isoflavones;|
| Active Comparator: 3<br> | Dietary Supplement: Soy isoflavones<br>* Three pills that delivered 120 mg aglycone isoflavones per day for two years<br>* Other names: Soy germ isoflavones;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density |  | One year and two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood biochemical bone markers (osteocalcin, bone-specific alkaline phosphatase, cross-linked N-telopeptides of type 1 collagen) |  | One year and two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Soy isoflavones, Postmenopausal women, Safety, Efficacy, Effective dosage