Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss - Full Text View

Sponsors and Collaborators:	Baylor College of Medicine University of California Kaiser Foundation Research Institute University of Georgia University of Alabama at Birmingham Texas A&M University
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00665860

Purpose

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

Condition	Intervention
Osteoporosis	Dietary Supplement: Placebo Dietary Supplement: Soy isoflavones

MedlinePlus related topics: Dietary Supplements Osteoporosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Safety, Efficacy, and Optimal Dosage of Soy Isoflavones to Prevent Osteoporosis

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

Bone mineral density [ Time Frame: One year and two years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Blood biochemical bone markers (osteocalcin, bone-specific alkaline phosphatase, cross-linked N-telopeptides of type 1 collagen) [ Time Frame: One year and two years ] [ Designated as safety issue: No ]

Enrollment:	403
Study Start Date:	April 2001
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Dietary Supplement: Placebo Three pills per day for two years
2: Active Comparator	Dietary Supplement: Soy isoflavones Three pills that delivered 80 mg of aglycone isoflavones per day for two years
3: Active Comparator	Dietary Supplement: Soy isoflavones Three pills that delivered 120 mg aglycone isoflavones per day for two years

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.

Eligibility

Ages Eligible for Study:	40 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665860

Locations

United States, California
University of California
Davis, California, United States, 95616
United States, Georgia
University of Georgia
Athens, Georgia, United States, 30602
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

University of California

Kaiser Foundation Research Institute

University of Georgia

University of Alabama at Birmingham

Texas A&M University

Investigators

Study Director:

William W. Wong, Ph.D.

Baylor College of Medicine

More Information

Click here for more information on this study: Osteoporosis Prevention Using Soy (OPUS) This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Responsible Party:	Baylor College of Medicine ( William W. Wong/Project Director )
Study ID Numbers:	TEXW-2001-04550, 2001-52102-11255
Study First Received:	April 22, 2008
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00665860
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

Osteoporosis
Soy isoflavones
Postmenopausal women

Safety
Efficacy
Effective dosage

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on January 16, 2009