Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss (OPUS)
November 25, 2020 updated by: William Wong, Baylor College of Medicine
Safety, Efficacy, and Optimal Dosage of Soy Isoflavones to Prevent Osteoporosis
The purpose of this study is to determine whether soy isoflavone supplementation is safe and effective to prevent bone loss in postmenopausal women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
403
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Davis, California, United States, 95616
- University of California
-
-
Georgia
-
Athens, Georgia, United States, 30602
- University of Georgia
-
-
Texas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 2
|
Three pills that delivered 80 mg of aglycone isoflavones per day for two years
Other Names:
Three pills that delivered 120 mg aglycone isoflavones per day for two years
Other Names:
|
|
ACTIVE_COMPARATOR: 3
|
Three pills that delivered 80 mg of aglycone isoflavones per day for two years
Other Names:
Three pills that delivered 120 mg aglycone isoflavones per day for two years
Other Names:
|
|
PLACEBO_COMPARATOR: 1
Placebo
|
Three pills per day for two years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Bone mineral density
Time Frame: One year and two years
|
One year and two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood biochemical bone markers (osteocalcin, bone-specific alkaline phosphatase, cross-linked N-telopeptides of type 1 collagen)
Time Frame: One year and two years
|
One year and two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: William W. Wong, Ph.D., Baylor College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2001
Primary Completion (ACTUAL)
June 1, 2006
Study Completion (ACTUAL)
June 1, 2006
Study Registration Dates
First Submitted
April 22, 2008
First Submitted That Met QC Criteria
April 22, 2008
First Posted (ESTIMATE)
April 24, 2008
Study Record Updates
Last Update Posted (ACTUAL)
November 27, 2020
Last Update Submitted That Met QC Criteria
November 25, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEXW-2001-04550
- 2001-52102-11255
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.