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

Primary Purpose

Osteoporosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Placebo

Soy isoflavones

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis, Soy isoflavones, Postmenopausal women, Safety, Efficacy, Effective dosage

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University of California
University of Georgia
Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Placebo

Outcomes

Primary Outcome Measures

Bone mineral density

Secondary Outcome Measures

Blood biochemical bone markers (osteocalcin, bone-specific alkaline phosphatase, cross-linked N-telopeptides of type 1 collagen)

Full Information

NCT ID

NCT00665860

First Posted

April 22, 2008

Last Updated

November 25, 2020

Sponsor

Baylor College of Medicine

Collaborators

University of California, Kaiser Foundation Research Institute, University of Georgia, University of Alabama at Birmingham, Texas A&M University

1. Study Identification

Unique Protocol Identification Number

NCT00665860

Brief Title

Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss

Acronym

OPUS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

April 2001 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baylor College of Medicine

Collaborators

University of California, Kaiser Foundation Research Institute, University of Georgia, University of Alabama at Birmingham, Texas A&M University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

Osteoporosis, Soy isoflavones, Postmenopausal women, Safety, Efficacy, Effective dosage

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

403 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Three pills per day for two years

Intervention Type

Dietary Supplement

Intervention Name(s)

Soy isoflavones

Other Intervention Name(s)

Soy germ isoflavones

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Soy isoflavones

Other Intervention Name(s)

Soy germ isoflavones

Intervention Description

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

Primary Outcome Measure Information:

Title

Bone mineral density

Time Frame

One year and two years

Secondary Outcome Measure Information:

Title

Blood biochemical bone markers (osteocalcin, bone-specific alkaline phosphatase, cross-linked N-telopeptides of type 1 collagen)

Time Frame

One year and two years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William W. Wong, Ph.D.

Organizational Affiliation

Baylor College of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

University of California

City

Davis

State/Province

California

ZIP/Postal Code

95616

Country

United States

Facility Name

University of Georgia

City

Athens

State/Province

Georgia

ZIP/Postal Code

30602

Country

United States

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15618602

Citation

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.

Results Reference

result

PubMed Identifier

21177797

Citation

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.

Results Reference

derived

PubMed Identifier

19759166

Citation

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.

Results Reference

derived

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Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss

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