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 Crohns 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
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