NCT00665860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

5.2 years

First QC Date

April 22, 2008

Last Update Submit

November 25, 2020

Conditions

Osteoporosis

Keywords

OsteoporosisSoy isoflavonesPostmenopausal womenSafetyEfficacyEffective dosage

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    One year and two years

Secondary Outcomes (1)

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

    One year and two years

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

2

ACTIVE COMPARATOR
Dietary Supplement: Soy isoflavones

3

ACTIVE COMPARATOR
Dietary Supplement: Soy isoflavones

Interventions

PlaceboDIETARY_SUPPLEMENT

Three pills per day for two years

1
Soy isoflavonesDIETARY_SUPPLEMENT

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

Also known as: Soy germ isoflavones
2

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California

Davis, California, 95616, United States

Location

University of Georgia

Athens, Georgia, 30602, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (3)

  • 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.

    PMID: 15618602RESULT

  • 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.

    PMID: 21177797DERIVED

  • 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.

    PMID: 19759166DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and Beverages

Study Officials

  • William W. Wong, Ph.D.

    Baylor College of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

April 1, 2001

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

November 27, 2020

Record last verified: 2020-11

Locations

US(3)