Osteoporosis Clinical Trial
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.
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:
1. trabecular bone quality in the lower leg (as measured by pQCT)
2. cortical bone BMD and quality in the lower leg (as measured by pQCT)
3. trabecular and cortical bone BMD and quality in the wrist (as measured by pQCT)
4. BMD at the hip and spine (as measured by dual x-ray absorptiometry, DXA)
5. 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.
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