Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss

Osteoporosis Clinical Trial

— OPUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665860
• Other study ID #: TEXW-2001-04550
• Secondary ID: 2001-52102-11255
• Status: Completed
• Phase: N/A
• Start date: April 2001
• Est. completion date: June 2006

Study information

• Verified date: November 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Dietary Supplement:
• Placebo
Three pills per day for two years
• Soy isoflavones
Three pills that delivered 80 mg of aglycone isoflavones per day for two years
• Soy isoflavones
Three pills that delivered 120 mg aglycone isoflavones per day for two years

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia
United States	University of California	Davis	California
United States	Baylor College of Medicine	Houston	Texas

Sponsors (6)

Lead Sponsor	Collaborator
Baylor College of Medicine	Kaiser Foundation Research Institute, Texas A&M University, University of Alabama at Birmingham, University of California, University of Georgia

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density		One year and two years
Secondary	Blood biochemical bone markers (osteocalcin, bone-specific alkaline phosphatase, cross-linked N-telopeptides of type 1 collagen)		One year and two years