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Sponsors and Collaborators: |
University Health Network, Toronto The Physicians |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00420940 |
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.
Condition | Intervention | Phase |
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Bone Density Osteopenia Osteoporosis Post-Menopause |
Device: Juvent 1000 Dynamic Motion Therapy Platform |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Daily Whole-Body Vibration on Tibial Trabecular Bone Mineral Density in Osteopenic Postmenopausal Women |
Estimated Enrollment: | 200 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
90 Hz whole-body vibration
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Device: Juvent 1000 Dynamic Motion Therapy Platform
whole-body vibration at a magnitude of ~0.3g (acceleration due to the gravity)at a frequency of 30 Hz or 90 Hz
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2: Experimental
30 Hz whole-body vibration
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Device: Juvent 1000 Dynamic Motion Therapy Platform
whole-body vibration at a magnitude of ~0.3g (acceleration due to the gravity)at a frequency of 30 Hz or 90 Hz
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3: No Intervention
control group (receiving no vibration)
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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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5G 2C4 |
Principal Investigator: | Angela M Cheung, M.D., Ph.D. | University Health Network, University of Toronto |
Responsible Party: | University Health Network/University of Toronto ( PI - Dr. Angela M. Cheung ) |
Study ID Numbers: | 06-0332-AE, PSI 06-28 |
Study First Received: | January 9, 2007 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00420940 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
vibration mechanical loading bone mineral density women's health osteoporosis |
Musculoskeletal Diseases Asthenia Osteoporosis |
Bone Diseases, Metabolic Bone Diseases Menopause |
Musculoskeletal Diseases Osteoporosis Bone Diseases, Metabolic Bone Diseases |