The Influence of Vibration on Bone Mineral Density in Women Who Have Weak Bones After Menopause

NCT ID: NCT00420940

Last Updated: 2010-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2009-12-31

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.

Conditions

Bone Density; Osteopenia; Osteoporosis; Post-Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

90 Hz whole-body vibration

20-minute daily whole-body vibration at 90 Hz and 0.3g

Group Type: EXPERIMENTAL

Juvent 1000 Dynamic Motion Therapy (DMT) Platform

Intervention Type: 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

30 Hz whole-body vibration

20-minute daily whole-body vibration at 90 Hz and 0.3g

Group Type: EXPERIMENTAL

Juvent 1000 Dynamic Motion Therapy (DMT) Platform

Intervention Type: 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

control

control group (receiving no vibration)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Juvent 1000 Dynamic Motion Therapy (DMT) Platform

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

Juvent 1000 Dynamic Motion Therapy (DMT) Platform

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

Other Intervention Names

low magnitude whole-body vibration platform; low magnitude whole-body vibration platform

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

University Health Network/University of Toronto

Principal Investigators

Angela M Cheung, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Health Network, University of Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 22084333 (View on PubMed)

Other Identifiers

PSI 06-28

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

06-0332-AE

Identifier Type: -

Identifier Source: org_study_id