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NCT00665860

Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss

NCT ID: NCT00665860

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

403 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2006-06-30

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.

Conditions

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Osteoporosis

Keywords

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Osteoporosis Soy isoflavones Postmenopausal women Safety Efficacy Effective dosage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Three pills per day for two years

2

Group Type ACTIVE_COMPARATOR

Soy isoflavones

Intervention Type DIETARY_SUPPLEMENT

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

3

Group Type ACTIVE_COMPARATOR

Soy isoflavones

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Placebo

Three pills per day for two years

Intervention Type DIETARY_SUPPLEMENT

Soy isoflavones

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

Intervention Type DIETARY_SUPPLEMENT

Soy isoflavones

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Soy germ isoflavones Soy germ isoflavones

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California

OTHER

Sponsor Role collaborator

Kaiser Foundation Research Institute

OTHER

Sponsor Role collaborator

University of Georgia

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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William Wong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William W. Wong, Ph.D.

Role: STUDY_DIRECTOR

Baylor College of Medicine

Locations

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University of California

Davis, California, United States

Site Status

University of Georgia

Athens, Georgia, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

References

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Ellis KJ, Shypailo RS, Steinberg FM, Lewis RD, Young RL, Wong WW. Reproducibility of fan-beam DXA measurements in adults and phantoms. J Clin Densitom. 2004 Winter;7(4):413-8. doi: 10.1385/jcd:7:4:413.

Reference Type RESULT

PMID: 15618602 (View on PubMed)

Steinberg FM, Murray MJ, Lewis RD, Cramer MA, Amato P, Young RL, Barnes S, Konzelmann KL, Fischer JG, Ellis KJ, Shypailo RJ, Fraley JK, Smith EO, Wong WW. Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women. Am J Clin Nutr. 2011 Feb;93(2):356-67. doi: 10.3945/ajcn.110.008359. Epub 2010 Dec 22.

Reference Type DERIVED

PMID: 21177797 (View on PubMed)

Wong WW, Lewis RD, Steinberg FM, Murray MJ, Cramer MA, Amato P, Young RL, Barnes S, Ellis KJ, Shypailo RJ, Fraley JK, Konzelmann KL, Fischer JG, Smith EO. Soy isoflavone supplementation and bone mineral density in menopausal women: a 2-y multicenter clinical trial. Am J Clin Nutr. 2009 Nov;90(5):1433-9. doi: 10.3945/ajcn.2009.28001. Epub 2009 Sep 16.

Reference Type DERIVED

PMID: 19759166 (View on PubMed)

Other Identifiers

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2001-52102-11255

Identifier Type: -

Identifier Source: secondary_id

TEXW-2001-04550

Identifier Type: -

Identifier Source: org_study_id