Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420940
Status:
COMPLETED
Last Update Posted:
2010-04-08
First Post:
2007-01-09
Brief Title:
The Influence of Vibration on Bone Mineral Density in Women Who Have Weak Bones After Menopause
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
The Effect of Daily Whole-Body Vibration on Tibial Trabecular Bone Mineral Density in Osteopenic Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PSI 06-28 | OTHER_GRANT | The Physicians Services Incorporated Foundation | None |