Bone DensityPhase 3NCT00420940
The Influence of Vibration on Bone Mineral Density in Women Who Have Weak Bones After Menopause
A Phase 3 study testing Juvent 1000 Dynamic Motion Therapy (DMT) Platform in people with Bone Density and Osteopenia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study will examine whether whole-body vibration slows down bone loss in healthy postmenopausal women with osteopenia. Whole-body vibration is a promising novel therapy that involves standing on a platform which produces extremely small and fast up-and-down movements. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Density, Osteopenia, Osteoporosis
- What is being tested?
- Juvent 1000 Dynamic Motion Therapy (DMT) Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2006to Dec 2009
- 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
- osteopenic
- postmenopausal
Who cannot join
- use of HRT in the past 12 months
- use of raloxifene or parathyroid hormone in the past 6 months
- use of bisphosphonates or fluoride in the past 3 months or ever taken for more than 3 months
- current use of calcitonin
- use of other medications that may indirectly affect bone metabolism
- presence of metabolic bone disease or diseases that indirectly affect bone metabolism
Show all 14Show fewer
- occurrence of fragility fracture over 40 years of age
- presence of unhealed non-fragility fracture (i.e., occurring less then 6 months ago)
- having body mass ≤28 kg and ≥90 kg
- having knee or hip joint replacements and spine implants
- having poor balance (assessed by Timed-Up-and-Go)
- presence of other medical risks for the study
- inability to stand erect daily for 20 minutes
- planned vacation or other activities that would prevent one from using the platform for ≥1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Daily Whole-Body Vibration on Tibial Trabecular Bone Mineral Density in Osteopenic Postmenopausal Women
This study will examine whether whole-body vibration slows down bone loss in healthy postmenopausal women with osteopenia. Whole-body vibration is a promising novel therapy that involves standing on a platform which produces extremely small and fast up-and-down movements. Some but not all research studies have found that whole-body vibration slowed down bone loss in postmenopausal women. One of the reasons why different studies found different results may be because they used various speeds of vibration. This study looks at how different speeds of whole-body vibration influence bone mineral density differently in postmenopausal women who have osteopenia. Two hundred postmenopausal women will take part in this 12-month study. Women will be randomly assigned into three groups (67 women per group) and these groups will be compared. Group 1 will receive very fast whole-body vibration, Group 2 will receive fast whole-body vibration, and Group 3 will not receive whole-body vibration. We will look at various bone mineral density and bone quality measurements, obtained with three different types of technologies, at the beginning of the study and at 12 months of follow-up. The hypothesis of this study is that the in comparison to Group 3 (no vibration), Groups 1 and 2 will experience reduced bone loss over 12 months, and that the greatest reduction in bone loss will be experienced by Group 1. The results of this study will help us determine whether whole-body vibration at different speeds produces variable effects on bone, hence explaining the inconsistency of the results obtained in previous studies.
Read the detailed description
BACKGROUND:
Recent animal studies have shown that whole-body vibration increases bone mineral density. The effect of whole-body vibration on bone has been examined in only six small human studies with inconsistent results. Two of these studies have shown whole-body vibration reduces bone loss after menopause. Studies that used higher speed whole-body vibration may have produced greater reductions in bone loss.
OBJECTIVE AND HYPOTHESIS:
The objective of this study is to examine the effects of two whole-body vibration speeds trabecular BMD in the lower leg in osteopenic postmenopausal women. Two hundred postmenopausal women will take part in this 12-month study. Women will be randomly assigned into three groups (67 women per group) and these groups will be compared. Group 1 will receive very fast (90 Hz) whole-body vibration, Group 2 will receive fast (30 Hz) whole-body vibration, and Group 3 will not receive whole-body vibration. The hypothesis of this study is that the in comparison to Group 3 (no vibration), Groups 1 (very fast vibration, 90 Hz) and 2 (fast vibration, 30 Hz) will experience reduced bone loss over 12 months, and that the greatest reduction in bone loss will be experienced by Group 1.
METHODOLOGY:
Women with any clinical conditions that affect bone and those receiving drugs that affect bone will be excluded. The whole-body vibration therapy will involve standing barefoot and upright on a vibration platform daily for 20 minutes. Data will be collected at baseline, and at 12 months of follow-up. Our primary analysis will evaluate whether there are differences in changes in trabecular BMD in the lower leg (as measured by peripheral quantitative computed tomography; pQCT) between Groups 1, 2, and 3. Our secondary analyses will examine whether there are differences in changes in the following bone characteristics between Groups 1, 2, and 3:
- trabecular bone quality in the lower leg (as measured by pQCT)
- cortical bone BMD and quality in the lower leg (as measured by pQCT)
- trabecular and cortical bone BMD and quality in the wrist (as measured by pQCT)
- BMD at the hip and spine (as measured by dual x-ray absorptiometry, DXA)
- BMD and quality at the heel (as measured by quantitative ultrasound).
SIGNIFICANCE:
Based on current scientific understanding of bone remodeling, vibration devices have the potential to play a significant part in maintaining bone health in postmenopausal women. The results of this study will help us determine whether low-magnitude, high-frequency WBV at different vibration rates produces variable effects on bone, hence explaining the inconsistency of the results obtained previously. This study will also lay the ground work for future large-scale randomized controlled trials that are needed to investigate the long-term effects of WBV on preventing postmenopausal bone loss. If effective, WBV can be another non-pharmaceutical strategy to decrease bone loss in postmenopausal women. This in turn will decrease the number of osteoporotic fractures and their associated morbidity and mortality.
- Conditions
- Bone Density, Osteopenia, Osteoporosis, Post-Menopause
- Being tested
- Juvent 1000 Dynamic Motion Therapy (DMT) Platform
- Keywords
- vibration, mechanical loading, bone mineral density, women's health, osteoporosis
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvent 1000 Dynamic Motion Therapy (DMT) PlatformDevice
Also called low magnitude whole-body vibration platform
Standing on a DMT whole-body vibration platform for 20 minutes per day at a frequency of 90 Hz and acceleration due to gravity of 0.3g
Juvent 1000 Dynamic Motion Therapy (DMT) PlatformDevice
Also called low magnitude whole-body vibration platform
Standing on a DMT whole-body vibration platform for 20 minutes per day at a frequency of 90 Hz and acceleration due to gravity of 0.3g
| Study group | Role | What they receive |
|---|---|---|
| 90 Hz whole-body vibration | Experimental | 20-minute daily whole-body vibration at 90 Hz and 0.3g Receives: Device: Juvent 1000 Dynamic Motion Therapy (DMT) Platform |
| 30 Hz whole-body vibration | Experimental | 20-minute daily whole-body vibration at 90 Hz and 0.3g Receives: Device: Juvent 1000 Dynamic Motion Therapy (DMT) Platform |
| control | No intervention | control group (receiving no vibration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trabecul volumetric bone mineral density (BMD) of the lower tibia (using peripheral quantitative computed tomography; pQCT))
Measured: Baseline and 12 months
Secondary outcomes (11)
Total BMD of the lower tibia (using pQCT)
Measured: Baseline and 12 months
Cortical BMD and cortical thickness of the lower tibia (using pQCT)
Measured: Baseline and 12 months
Trabecular thickness, separation, and number of the lower tibia (using pQCT)
Measured: Baseline and 12 months
Total BMD of the distal radius (using pQCT)
Measured: Baseline and 12 months
Cortical BMD and cortical thickness of the distal radius (using pQCT)
Measured: Baseline and 12 months
Trabecular BMD and thickness, separation, and number of the distal radius (using pQCT)
Measured: Baseline and 12 months
BMD at the total hip (using dual x-ray absorptiometry; DXA)
Measured: Baseline and 12 months
BMD at the femoral neck (using DXA)
Measured: Baseline and 12 months
BMD lumbar spine (using DXA)
Measured: Baseline and 12 months
BMD at the calcaneus (using quantitative ultrasound; QUS)
Measured: Baseline and 12 months
Speed of sound and broadband ultrasound attenuation at the calcaneus (QUS)
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startNov 2006
- Primary completionDec 2009
- Study completionDec 2009
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 Bone DensityStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Angela M Cheung, M.D., Ph.D., Principal investigator, University Health Network, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420940
- Sponsor's protocol ID
- 06-0332-AE
- Other IDs
- PSI 06-28
- Status last verified
- Oct 2008
- First submitted
- 9 Jan 2007
- Last updated
- 8 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Slatkovska L, Alibhai SM, Beyene J, Hu H, Demaras A, Cheung AM. Effect of 12 months of whole-body vibration therapy on bone density and structure in postmenopausal women: a randomized trial. Ann Intern Med. 2011 Nov 15;155(10):668-79, W205. doi: 10.7326/0003-4819-155-10-201111150-00005.
PubMed 22084333
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Whole-Body Vibration on Tibial Trabecular Bone Mineral Density in Osteopenic Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00420940
- Acronym / sponsor ID
- 06-0332-AE
- Conditions
- Bone Density, Osteopenia, Osteoporosis, Post-Menopause
- Keywords
- vibration, mechanical loading, bone mineral density, women's health, osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Nov 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Jan 2007 (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.
This study will examine whether whole-body vibration slows down bone loss in healthy postmenopausal women with osteopenia. Whole-body vibration is a promising novel therapy that involves standing on a platform which produces extremely small and fast up-and-down movements. Some but not all research studies have found that whole-body vibration slowed down bone loss in postmenopausal women. One of the reasons why different studies found different results may be because they used various speeds of vibration. This study looks at how different speeds of whole-body vibration influence bone mineral density differently in postmenopausal women who have osteopenia. Two hundred postmenopausal women will take part in this 12-month study. Women will be randomly assigned into three groups (67 women per group) and these groups will be compared. Group 1 will receive very fast whole-body vibration, Group 2 will receive fast whole-body vibration, and Group 3 will not receive whole-body vibration. We will look at various bone mineral density and bone quality measurements, obtained with three different types of technologies, at the beginning of the study and at 12 months of follow-up. The hypothesis of this study is that the in comparison to Group 3 (no vibration), Groups 1 and 2 will experience reduced bone loss over 12 months, and that the greatest reduction in bone loss will be experienced by Group 1. The results of this study will help us determine whether whole-body vibration at different speeds produces variable effects on bone, hence explaining the inconsistency of the results obtained in previous studies.
Detailed description
BACKGROUND:
Recent animal studies have shown that whole-body vibration increases bone mineral density. The effect of whole-body vibration on bone has been examined in only six small human studies with inconsistent results. Two of these studies have shown whole-body vibration reduces bone loss after menopause. Studies that used higher speed whole-body vibration may have produced greater reductions in bone loss.
OBJECTIVE AND HYPOTHESIS:
The objective of this study is to examine the effects of two whole-body vibration speeds trabecular BMD in the lower leg in osteopenic postmenopausal women. Two hundred postmenopausal women will take part in this 12-month study. Women will be randomly assigned into three groups (67 women per group) and these groups will be compared. Group 1 will receive very fast (90 Hz) whole-body vibration, Group 2 will receive fast (30 Hz) whole-body vibration, and Group 3 will not receive whole-body vibration. The hypothesis of this study is that the in comparison to Group 3 (no vibration), Groups 1 (very fast vibration, 90 Hz) and 2 (fast vibration, 30 Hz) will experience reduced bone loss over 12 months, and that the greatest reduction in bone loss will be experienced by Group 1.
METHODOLOGY:
Women with any clinical conditions that affect bone and those receiving drugs that affect bone will be excluded. The whole-body vibration therapy will involve standing barefoot and upright on a vibration platform daily for 20 minutes. Data will be collected at baseline, and at 12 months of follow-up. Our primary analysis will evaluate whether there are differences in changes in trabecular BMD in the lower leg (as measured by peripheral quantitative computed tomography; pQCT) between Groups 1, 2, and 3. Our secondary analyses will examine whether there are differences in changes in the following bone characteristics between Groups 1, 2, and 3:
- trabecular bone quality in the lower leg (as measured by pQCT)
- cortical bone BMD and quality in the lower leg (as measured by pQCT)
- trabecular and cortical bone BMD and quality in the wrist (as measured by pQCT)
- BMD at the hip and spine (as measured by dual x-ray absorptiometry, DXA)
- BMD and quality at the heel (as measured by quantitative ultrasound).
SIGNIFICANCE:
Based on current scientific understanding of bone remodeling, vibration devices have the potential to play a significant part in maintaining bone health in postmenopausal women. The results of this study will help us determine whether low-magnitude, high-frequency WBV at different vibration rates produces variable effects on bone, hence explaining the inconsistency of the results obtained previously. This study will also lay the ground work for future large-scale randomized controlled trials that are needed to investigate the long-term effects of WBV on preventing postmenopausal bone loss. If effective, WBV can be another non-pharmaceutical strategy to decrease bone loss in postmenopausal women. This in turn will decrease the number of osteoporotic fractures and their associated morbidity and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 90 Hz whole-body vibration | Experimental | Device: Juvent 1000 Dynamic Motion Therapy (DMT) Platform20-minute daily whole-body vibration at 90 Hz and 0.3g |
| 30 Hz whole-body vibration | Experimental | Device: Juvent 1000 Dynamic Motion Therapy (DMT) Platform20-minute daily whole-body vibration at 90 Hz and 0.3g |
| control | No intervention | –control group (receiving no vibration) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- osteopenic
- postmenopausal
Key exclusion criteria (14 listed)
- use of HRT in the past 12 months
- use of raloxifene or parathyroid hormone in the past 6 months
- use of bisphosphonates or fluoride in the past 3 months or ever taken for more than 3 months
- current use of calcitonin
- use of other medications that may indirectly affect bone metabolism
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 |
|---|---|---|
| Juvent 1000 Dynamic Motion Therapy (DMT) PlatformAlso: low magnitude whole-body vibration platformStanding on a DMT whole-body vibration platform for 20 minutes per day at a frequency of 90 Hz and acceleration due to gravity of 0.3g | Device | 90 Hz whole-body vibration |
| Juvent 1000 Dynamic Motion Therapy (DMT) PlatformAlso: low magnitude whole-body vibration platformStanding on a DMT whole-body vibration platform for 20 minutes per day at a frequency of 90 Hz and acceleration due to gravity of 0.3g | Device | 30 Hz whole-body vibration |
Primary outcome
Trabecul volumetric bone mineral density (BMD) of the lower tibia (using peripheral quantitative computed tomography; pQCT))
Time frame: Baseline and 12 months
11 secondary outcomes
Total BMD of the lower tibia (using pQCT)
Time frame: Baseline and 12 months
Cortical BMD and cortical thickness of the lower tibia (using pQCT)
Time frame: Baseline and 12 months
Trabecular thickness, separation, and number of the lower tibia (using pQCT)
Time frame: Baseline and 12 months
Total BMD of the distal radius (using pQCT)
Time frame: Baseline and 12 months
Cortical BMD and cortical thickness of the distal radius (using pQCT)
Time frame: Baseline and 12 months
Trabecular BMD and thickness, separation, and number of the distal radius (using pQCT)
Time frame: Baseline and 12 months
BMD at the total hip (using dual x-ray absorptiometry; DXA)
Time frame: Baseline and 12 months
BMD at the femoral neck (using DXA)
Time frame: Baseline and 12 months
BMD lumbar spine (using DXA)
Time frame: Baseline and 12 months
BMD at the calcaneus (using quantitative ultrasound; QUS)
Time frame: Baseline and 12 months
Speed of sound and broadband ultrasound attenuation at the calcaneus (QUS)
Time frame: Baseline and 12 months
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 8 Apr 2010.
- Derived from this study: PubMed 22084333Slatkovska L, Alibhai SM, Beyene J, Hu H, Demaras A, Cheung AM. Effect of 12 months of whole-body vibration therapy on bone density and structure in postmenopausal women: a randomized trial. Ann Intern Med. 2011 Nov 15;155(10):668-79, W205. doi: 10.7326/0003-4819-155-10-201111150-00005.
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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.
Angela M Cheung, M.D., Ph.D. principal investigator
University Health Network, University of Toronto
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 Juvent 1000 Dynamic Motion Therapy (DMT) Platform in people with Bone Density and Osteopenia, run by University Health Network, Toronto 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 2 inclusion and 14 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 8 Apr 2010. 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. 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?
Trabecul volumetric bone mineral density (BMD) of the lower tibia (using peripheral quantitative computed tomography; pQCT)) (time frame: Baseline and 12 months). 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 NCT00420940, 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 8 Apr 2010.