OPUS: Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss

Sponsor

Baylor College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00665860

Collaborator

University of California (Other), Kaiser Foundation Research Institute (Other), University of Georgia (Other), University of Alabama at Birmingham (Other), Texas A&M University (Other)

403

Enrollment

Locations

Arms

Duration (Months)

134.3

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Dietary Supplement: Placebo Dietary Supplement: Soy isoflavones Dietary Supplement: Soy isoflavones	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

403 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2001

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Placebo	Dietary Supplement: Placebo Three pills per day for two years
Active Comparator: 2	Dietary Supplement: Soy isoflavones Three pills that delivered 80 mg of aglycone isoflavones per day for two years Other Names: Soy germ isoflavones
Active Comparator: 3	Dietary Supplement: Soy isoflavones Three pills that delivered 120 mg aglycone isoflavones per day for two years Other Names: Soy germ isoflavones

Arm

Intervention/Treatment

Placebo Comparator: 1

Placebo

Dietary Supplement: Placebo

Three pills per day for two years

Active Comparator: 2

Dietary Supplement: Soy isoflavones

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

Other Names:

Soy germ isoflavones

Active Comparator: 3

Dietary Supplement: Soy isoflavones

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

Other Names:

Soy germ isoflavones

Outcome Measures

Primary Outcome Measures

Bone mineral density [One year and two years]

Secondary Outcome Measures

Blood biochemical bone markers (osteocalcin, bone-specific alkaline phosphatase, cross-linked N-telopeptides of type 1 collagen) [One year and two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California	Davis	California	United States	95616
2	University of Georgia	Athens	Georgia	United States	30602
3	Baylor College of Medicine	Houston	Texas	United States	77030