OsteoporosisPhase 3NCT00204425
Effect of Exercise Training and Soy-based Nutritional Supplementation on Prevention of Osteoporosis
A Phase 3 study testing exercise/soy isoflavone in people with Osteoporosis and Osteopenia, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- exercise/soy isoflavone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 351 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2004to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Post-menopausal women
Who cannot join
- 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
Show all 16Show fewer
- 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
- Currently participating in vigorous exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Combined Exercise Therapy and Isoflavone Supplementation on Prevention of Osteoporosis
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.
Read the detailed description
Exercise training is effective for increasing bone mineral density and preventing osteoporosis, but the effects are small. When estrogen replacement is given to post-menopausal women the effectiveness of exercise training for improving bone mineral density is increased. Currently many women are concerned about the risks of taking hormone-replacement therapy and are seeking alternative therapies. The purpose of our study therefore is to use an estrogen-like dietary supplement derived from soy called a phytoestrogen (soy isoflavone) combined with exercise training for improving bone mineral density.
Comparisons: Four groups are being compared: 1) Exercise training (i.e. weight lifting 2 times per week and walking 4 times per week) plus soy isoflavone (90 mg aglycone equivalents per day); 2) Exercise training plus placebo; 3) Exercise placebo (flexibility exercises four times per week) plus soy isoflavone; 4) Exercise placebo plus placebo.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- exercise/soy isoflavone
- Keywords
- Osteoporosis, Bone, Exercise, Soy, Isoflavone, Phytoestrogen, Menopause, Lipids
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise/soy isoflavoneDietary supplement
Also called Archer Daniels Midland
Exercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | exercise/soy isoflavone Receives: Dietary Supplement: exercise/soy isoflavone |
| 2 | Experimental | exercise/isoflavone placebo Receives: Dietary Supplement: exercise/soy isoflavone |
| 3 | Experimental | exercise placebo/soy isoflavone Receives: Dietary Supplement: exercise/soy isoflavone |
| 4 | Placebo comparator | exercise placebo/isoflavone placebo Receives: Dietary Supplement: exercise/soy isoflavone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar spine bone mineral density at 12 and 24 months
Measured: 2 years
Secondary outcomes (16)
Bone mineral density of the proximal femur at 12 and 24 months.
Measured: 2 years
Bone mineral density of the whole body at 12 and 24 months.
Measured: 2 years
Bone quality of the radius and tibia (ultrasound) at 12 and 24 months.
Measured: 2 years
Geometry of the proximal femur at at 12 and 24 months.
Measured: 2 years
Lean tissue mass at 12 and 24 months.
Measured: 2 years
Fat mass at 12 and 24 months.
Measured: 2 years
Body mass index at 12 and 24 months.
Measured: 2 years
Waist girth at 12 and 24 months.
Measured: 2 years
Blood lipids at 12 and 24 months.
Measured: 2 years
Muscular strength at 12 and 24 months.
Measured: 2 years
Self-paced walking ability at 12 and 24 months.
Measured: 2 years
Balance at 12 and 24 months.
Measured: 2 years
Flexibility at 12 and 24 months.
Measured: 2 years
Breast density at 24 months
Measured: 2 years
Endometrial thickness at 24 months.
Measured: 2 years
Menopausal symptoms at 3, 6, 9, 12, 15, 18, 21, and 24 months.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionDec 2007
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
- Investigators
- Philip D Chilibeck, PhD, Principal investigator, University of SaskatchewanH J Biem, M.D., Study director, University of SaskatchewanAllison Case, M.D., Study director, University of SaskatchewanOlufemi Olantunbosun, M.D., Study director, University of SaskatchewanRoger Pierson, PhD, Study director, University of SaskatchewanSusan Whiting, PhD, Study director, University of SaskatchewanPunam Pahwa, PhD, Study director, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204425
- Sponsor's protocol ID
- Bio 03-1077
- Other IDs
- 124322 FRN68095
- Status last verified
- Sep 2011
- First submitted
- 12 Sep 2005
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15001805
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Exercise Therapy and Isoflavone Supplementation on Prevention of Osteoporosis
- ClinicalTrials.gov ID
- NCT00204425
- Acronym / sponsor ID
- Bio 03-1077
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- Osteoporosis, Bone, Exercise, Soy, Isoflavone, Phytoestrogen, Menopause, Lipids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Dec 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Exercise training is effective for increasing bone mineral density and preventing osteoporosis, but the effects are small. When estrogen replacement is given to post-menopausal women the effectiveness of exercise training for improving bone mineral density is increased. Currently many women are concerned about the risks of taking hormone-replacement therapy and are seeking alternative therapies. The purpose of our study therefore is to use an estrogen-like dietary supplement derived from soy called a phytoestrogen (soy isoflavone) combined with exercise training for improving bone mineral density.
Comparisons: Four groups are being compared: 1) Exercise training (i.e. weight lifting 2 times per week and walking 4 times per week) plus soy isoflavone (90 mg aglycone equivalents per day); 2) Exercise training plus placebo; 3) Exercise placebo (flexibility exercises four times per week) plus soy isoflavone; 4) Exercise placebo plus placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: exercise/soy isoflavoneexercise/soy isoflavone |
| 2 | Experimental | Dietary Supplement: exercise/soy isoflavoneexercise/isoflavone placebo |
| 3 | Experimental | Dietary Supplement: exercise/soy isoflavoneexercise placebo/soy isoflavone |
| 4 | Placebo comparator | Dietary Supplement: exercise/soy isoflavoneexercise placebo/isoflavone placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Post-menopausal women
Key exclusion criteria (16 listed)
- Diagnosed osteoporotic
- Previous fragility fractures
- Previous breast cancer
- Previous endometrial cancer
- Taken bisphosphonates in past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise/soy isoflavoneAlso: Archer Daniels MidlandExercise 6 days per week, 90 mg/day aglycone isoflavone Exercise placebo (stretching), isoflavone placebo | Dietary supplement | 1, 2, 3, 4 |
Primary outcome
Lumbar spine bone mineral density at 12 and 24 months
Time frame: 2 years
16 secondary outcomes
Bone mineral density of the proximal femur at 12 and 24 months.
Time frame: 2 years
Bone mineral density of the whole body at 12 and 24 months.
Time frame: 2 years
Bone quality of the radius and tibia (ultrasound) at 12 and 24 months.
Time frame: 2 years
Geometry of the proximal femur at at 12 and 24 months.
Time frame: 2 years
Lean tissue mass at 12 and 24 months.
Time frame: 2 years
Fat mass at 12 and 24 months.
Time frame: 2 years
Body mass index at 12 and 24 months.
Time frame: 2 years
Waist girth at 12 and 24 months.
Time frame: 2 years
Blood lipids at 12 and 24 months.
Time frame: 2 years
Muscular strength at 12 and 24 months.
Time frame: 2 years
Self-paced walking ability at 12 and 24 months.
Time frame: 2 years
Balance at 12 and 24 months.
Time frame: 2 years
Flexibility at 12 and 24 months.
Time frame: 2 years
Breast density at 24 months
Time frame: 2 years
Endometrial thickness at 24 months.
Time frame: 2 years
Menopausal symptoms at 3, 6, 9, 12, 15, 18, 21, and 24 months.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2011.
- Background: PubMed 15001805Chilibeck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip D Chilibeck, PhD principal investigator
University of Saskatchewan
H J Biem, M.D. study director
University of Saskatchewan
Allison Case, M.D. study director
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing exercise/soy isoflavone in people with Osteoporosis and Osteopenia, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar spine bone mineral density at 12 and 24 months (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00204425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2011.