The Influence of Vibration on Bone Mineral Density in Women Who Have Weak Bones After Menopause
Primary Purpose
Bone Density, Osteopenia, Osteoporosis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Juvent 1000 Dynamic Motion Therapy (DMT) Platform
Juvent 1000 Dynamic Motion Therapy (DMT) Platform
Sponsored by
About this trial
This is an interventional prevention trial for Bone Density focused on measuring vibration, mechanical loading, bone mineral density, women's health, osteoporosis
Eligibility Criteria
Inclusion Criteria:
- osteopenic
- postmenopausal
Exclusion Criteria:
- 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
- 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
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
90 Hz whole-body vibration
30 Hz whole-body vibration
control
Arm Description
20-minute daily whole-body vibration at 90 Hz and 0.3g
20-minute daily whole-body vibration at 90 Hz and 0.3g
control group (receiving no vibration)
Outcomes
Primary Outcome Measures
Trabecul volumetric bone mineral density (BMD) of the lower tibia (using peripheral quantitative computed tomography; pQCT))
Secondary Outcome Measures
Total BMD of the lower tibia (using pQCT)
Cortical BMD and cortical thickness of the lower tibia (using pQCT)
Trabecular thickness, separation, and number of the lower tibia (using pQCT)
Total BMD of the distal radius (using pQCT)
Cortical BMD and cortical thickness of the distal radius (using pQCT)
Trabecular BMD and thickness, separation, and number of the distal radius (using pQCT)
BMD at the total hip (using dual x-ray absorptiometry; DXA)
BMD at the femoral neck (using DXA)
BMD lumbar spine (using DXA)
BMD at the calcaneus (using quantitative ultrasound; QUS)
Speed of sound and broadband ultrasound attenuation at the calcaneus (QUS)
Full Information
NCT ID
NCT00420940
First Posted
January 9, 2007
Last Updated
April 7, 2010
Sponsor
University Health Network, Toronto
Collaborators
The Physicians' Services Incorporated Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00420940
Brief Title
The Influence of Vibration on Bone Mineral Density in Women Who Have Weak Bones After Menopause
Official Title
The Effect of Daily Whole-Body Vibration on Tibial Trabecular Bone Mineral Density in Osteopenic Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
Collaborators
The Physicians' Services Incorporated Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Density, Osteopenia, Osteoporosis, Post-Menopause
Keywords
vibration, mechanical loading, bone mineral density, women's health, osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
90 Hz whole-body vibration
Arm Type
Experimental
Arm Description
20-minute daily whole-body vibration at 90 Hz and 0.3g
Arm Title
30 Hz whole-body vibration
Arm Type
Experimental
Arm Description
20-minute daily whole-body vibration at 90 Hz and 0.3g
Arm Title
control
Arm Type
No Intervention
Arm Description
control group (receiving no vibration)
Intervention Type
Device
Intervention Name(s)
Juvent 1000 Dynamic Motion Therapy (DMT) Platform
Other Intervention Name(s)
low magnitude whole-body vibration platform
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Juvent 1000 Dynamic Motion Therapy (DMT) Platform
Other Intervention Name(s)
low magnitude whole-body vibration platform
Intervention Description
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
Primary Outcome Measure Information:
Title
Trabecul volumetric bone mineral density (BMD) of the lower tibia (using peripheral quantitative computed tomography; pQCT))
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Total BMD of the lower tibia (using pQCT)
Time Frame
Baseline and 12 months
Title
Cortical BMD and cortical thickness of the lower tibia (using pQCT)
Time Frame
Baseline and 12 months
Title
Trabecular thickness, separation, and number of the lower tibia (using pQCT)
Time Frame
Baseline and 12 months
Title
Total BMD of the distal radius (using pQCT)
Time Frame
Baseline and 12 months
Title
Cortical BMD and cortical thickness of the distal radius (using pQCT)
Time Frame
Baseline and 12 months
Title
Trabecular BMD and thickness, separation, and number of the distal radius (using pQCT)
Time Frame
Baseline and 12 months
Title
BMD at the total hip (using dual x-ray absorptiometry; DXA)
Time Frame
Baseline and 12 months
Title
BMD at the femoral neck (using DXA)
Time Frame
Baseline and 12 months
Title
BMD lumbar spine (using DXA)
Time Frame
Baseline and 12 months
Title
BMD at the calcaneus (using quantitative ultrasound; QUS)
Time Frame
Baseline and 12 months
Title
Speed of sound and broadband ultrasound attenuation at the calcaneus (QUS)
Time Frame
Baseline and 12 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
osteopenic
postmenopausal
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela M Cheung, M.D., Ph.D.
Organizational Affiliation
University Health Network, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22084333
Citation
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. Erratum In: Ann Intern Med. 2011 Dec 20;155(12):860.
Results Reference
derived
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The Influence of Vibration on Bone Mineral Density in Women Who Have Weak Bones After Menopause
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