Safety and Effectiveness of Soy Phytoestrogens to Prevent... | NCT00665860

Studies
Safety and Effectiveness of Soy Phytoestrogens to Prevent Bone Loss

NCT00665860

Sponsor

Baylor College of Medicine

Status

Completed

Last Update Posted

Nov 27, 2020Actual

Enrollment

403Actual

Phase

Not Applicable

Conditions

Osteoporosis

Interventions

Placebo
Soy isoflavones
Soy isoflavones

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2001-52102-11255

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2001

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Apr 22, 2008

First Submission Date that Met QC Criteria

Apr 22, 2008

First Posted Date

Apr 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2020

Last Update Posted Date

Nov 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

William Wong, Professor, Baylor College of MedicinePrincipal Investigator

Lead Sponsor

Baylor College of MedicineOTHER

Collaborators

Name	Class
University of California	OTHER
Kaiser Foundation Research Institute	OTHER
University of Georgia	OTHER
University of Alabama at Birmingham

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

403Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Placebo	Dietary Supplement: Placebo
2	Active Comparator		Dietary Supplement: Soy isoflavones
3	Active Comparator		Dietary Supplement: Soy isoflavones

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement	Three pills per day for two years	1
Soy isoflavones

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone mineral density		One year and two years

Secondary Outcomes

Measure	Description	Time Frame
Blood biochemical bone markers (osteocalcin, bone-specific alkaline phosphatase, cross-linked N-telopeptides of type 1 collagen)		One year and two years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William W. Wong, Ph.D.	Baylor College of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California		Davis	California	95616	United States
University of Georgia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15618602	Result	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.
21177797	Derived	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.

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

ID	Term
D010940	Plant Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D014674	Plant Proteins, Dietary