Condition category
Musculoskeletal Diseases
Date applied
09/09/2005
Date assigned
09/09/2005
Last edited
17/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip David Chilibeck

ORCID ID

Contact details

University of Saskatchewan
College of Kinesiology
87 Campus Drive
Saskatoon
S7N 5B3
Canada
+1 306 343 6577
phil.chilibeck@usask.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00204425

Protocol/serial number

MCT-68095

Study information

Scientific title

Effect of combined exercise therapy and isoflavone supplementation on prevention of osteoporosis: a randomised controlled trial

Acronym

Study hypothesis

Exercise training and isoflavone supplementation will be additive for increasing bone mineral density.

Please note that as of 06/03/2009 the anticipated end date in this record was amended; the initial end date at the time of registration was 01/12/2007.

Ethics approval

University of Saskatchewan Biomedical Research Ethics Board (Bio-REB) gave approval on the 1st August 2003

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Osteoporosis

Intervention

Group 1: exercise training plus isoflavone placebo
Group 2: exercise training placebo (flexibility program) plus isoflavone therapy
Group 3: exercise training plus isoflavone therapy
Group 4: exercise training placebo plus isoflavone placebo

The exercise training intervention will consist of weight training combined with walking. The exercise training placebo will consist of home-based flexibility program (a type of training that has no effect on bone mineral). All participants will be required to fill out and return to the study staff daily activity logs throughout the study.

Intervention type

Drug

Phase

Not Applicable

Drug names

Isoflavone

Primary outcome measures

Lumbar spine bone mineral density

Secondary outcome measures

1. Bone mineral density of the proximal femur and whole body
2. Bone quality of the calcaneus
3. Geometry the proximal femur
4. Lean tissue mass
5. Fat mass
6. Body mass index
7. Waist girth
8. Skinfolds
9. Blood lipids
10. Breast density
11. Endometrial thickness
12. Menopausal symptoms
13. Physical activity levels
14. Muscular strength
15. Self-paced walking ability
16. Balance and flexibility

Overall trial start date

14/09/2004

Overall trial end date

30/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Post-menopausal women (age range of approximately 45 to 70 years)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

360 (351 at end of recruitment)

Participant exclusion criteria

1. Diagnosed osteoporosis
2. Previous fragility fractures
3. Above normal bone mineral density (equal to or above the young adult mean)
4. Breast or endometrial cancers
5. Women taking bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators, parathyroid hormone (PTH), or calcitonin in the past 12 months
6. Taking corticosteroids or diuretics
7. Diagnosed Crohn’s Disease and Cushing Disease
8. Women with allergies to soy
9. Severe osteoporosis
10. Smokers
11. Currently participating in vigorous exercise programs

Recruitment start date

14/09/2004

Recruitment end date

30/05/2008

Locations

Countries of recruitment

Canada

Trial participating centre

University of Saskatchewan
Saskatoon
S7N 5B3
Canada

Sponsor information

Organisation

University of Saskatchewan (Canada)

Sponsor details

105 Administration Place
Saskatoon
S7N 5A2
Canada

Sponsor type

Not defined

Website

http://www.usask.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-68095)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes