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Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss (OPUS)

This study has been completed.
Sponsor:
Collaborators:
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
First received: April 22, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety, Efficacy, and Optimal Dosage of Soy Isoflavones to Prevent Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

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

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

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Baylor College of Medicine:
Osteoporosis
Soy isoflavones
Postmenopausal women
 Safety
Efficacy
Effective dosage

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Phytoestrogens
Estrogens, Non-Steroidal
 Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013