NCT00204425

Brief Summary

The purpose of the study is to determine the effectiveness of combining exercise training (i.e. weight lifting and walking) and dietary supplementation with a soy-based nutritional supplement for increasing bone mineral density. We hypothesize that the exercise training and soy-based supplement will be additive for increasing bone mineral density.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
351

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

September 13, 2011

Status Verified

September 1, 2011

Enrollment Period

3 years

First QC Date

September 12, 2005

Last Update Submit

September 9, 2011

Conditions

OsteoporosisOsteopenia

Keywords

OsteoporosisBoneExerciseSoyIsoflavonePhytoestrogenMenopauseLipids

Outcome Measures

Primary Outcomes (1)

  • Lumbar spine bone mineral density at 12 and 24 months

    2 years

Secondary Outcomes (16)

  • Bone mineral density of the proximal femur at 12 and 24 months.

    2 years

  • Bone mineral density of the whole body at 12 and 24 months.

    2 years

  • Bone quality of the radius and tibia (ultrasound) at 12 and 24 months.

    2 years

  • Geometry of the proximal femur at at 12 and 24 months.

    2 years

  • Lean tissue mass at 12 and 24 months.

    2 years

  • +11 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

exercise/soy isoflavone

Dietary Supplement: exercise/soy isoflavone

2

EXPERIMENTAL

exercise/isoflavone placebo

Dietary Supplement: exercise/soy isoflavone

3

EXPERIMENTAL

exercise placebo/soy isoflavone

Dietary Supplement: exercise/soy isoflavone

4

PLACEBO COMPARATOR

exercise placebo/isoflavone placebo

Dietary Supplement: exercise/soy isoflavone

Interventions

exercise/soy isoflavoneDIETARY_SUPPLEMENT

Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo

Also known as: Archer Daniels Midland
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Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal women

You may not qualify if:

  • Diagnosed osteoporotic
  • Previous fragility fractures
  • Previous breast cancer
  • Previous endometrial cancer
  • Taken bisphosphonates in past 12 months
  • Taken hormone replacement therapy in past 12 months
  • Taken selective estrogen receptor modulators in past 12 months
  • Taken parathyroid hormone in past 12 months
  • Taken calcitonin in past 12 months
  • Currently taking corticosteroids
  • Currently taking a thiazide diuretic
  • Crohn's Disease
  • Cushing Disease
  • Allergy to soy
  • Severe osteoarthritis
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

Related Publications (1)

  • Chilibeck PD. Exercise and estrogen or estrogen alternatives (phytoestrogens, bisphosphonates)for preservation of bone mineral in postmenopausal women. Can J Appl Physiol. 2004 Feb;29(1):59-75. doi: 10.1139/h04-006.

    PMID: 15001805BACKGROUND

MeSH Terms

Conditions

OsteoporosisBone Diseases, MetabolicMotor Activity

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • Philip D Chilibeck, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

  • H J Biem, M.D.

    University of Saskatchewan

    STUDY DIRECTOR

  • Allison Case, M.D.

    University of Saskatchewan

    STUDY DIRECTOR

  • Olufemi Olantunbosun, M.D.

    University of Saskatchewan

    STUDY DIRECTOR

  • Roger Pierson, PhD

    University of Saskatchewan

    STUDY DIRECTOR

  • Susan Whiting, PhD

    University of Saskatchewan

    STUDY DIRECTOR

  • Punam Pahwa, PhD

    University of Saskatchewan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

December 1, 2004

Primary Completion

December 1, 2007

Study Completion

April 1, 2010

Last Updated

September 13, 2011

Record last verified: 2011-09

Locations

CA(1)