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| ID | Type | Description | Link |
|---|---|---|---|
| PSI 06-28 | Other Grant/Funding Number | The Physicians' Services Incorporated Foundation |
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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 90 Hz whole-body vibration | Experimental | 20-minute daily whole-body vibration at 90 Hz and 0.3g |
|
| 30 Hz whole-body vibration | Experimental | 20-minute daily whole-body vibration at 90 Hz and 0.3g |
|
| control | No Intervention | control group (receiving no vibration) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juvent 1000 Dynamic Motion Therapy (DMT) Platform | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Trabecul volumetric bone mineral density (BMD) of the lower tibia (using peripheral quantitative computed tomography; pQCT)) | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total BMD of the lower tibia (using pQCT) | Baseline and 12 months | |
| Cortical BMD and cortical thickness of the lower tibia (using pQCT) | Baseline and 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela M Cheung, M.D., Ph.D. | University Health Network, University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22084333 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 27, 2012 | |
| Reset | Feb 28, 2012 |
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|
| Juvent 1000 Dynamic Motion Therapy (DMT) Platform | Device | 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 |
|
|
| Trabecular thickness, separation, and number of the lower tibia (using pQCT) |
| Baseline and 12 months |
| Total BMD of the distal radius (using pQCT) | Baseline and 12 months |
| Cortical BMD and cortical thickness of the distal radius (using pQCT) | Baseline and 12 months |
| Trabecular BMD and thickness, separation, and number of the distal radius (using pQCT) | Baseline and 12 months |
| BMD at the total hip (using dual x-ray absorptiometry; DXA) | Baseline and 12 months |
| BMD at the femoral neck (using DXA) | Baseline and 12 months |
| BMD lumbar spine (using DXA) | Baseline and 12 months |
| BMD at the calcaneus (using quantitative ultrasound; QUS) | Baseline and 12 months |
| Speed of sound and broadband ultrasound attenuation at the calcaneus (QUS) | Baseline and 12 months |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 27, 2012 | Feb 28, 2012 |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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