"VIBES"--Low Magnitude Mechanical Stimulation to Improve Bone Mineral Density

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to determine if daily low magnitude, high frequency whole body vibration can improve bone density in seniors.

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Detailed Description

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The treatment options for osteoporosis, a major health complication in the aged population, are limited to pharmacologic interventions, the majority of which are antiresorptive. Preliminary data demonstrate that high frequency, low magnitude mechanical stimulation (LMMS) can preserve bone mineral density (BMD) by preventing bone resorption due to disuse and aging, and can stimulate new bone formation.

To confirm and extend these observations, this study is a three-year, double-blind, randomized, placebo-controlled clinical trial of LMMS in 200 elderly women and men (60 years of age and older). A clinical center located in Boston, MA has recruited participants from multiple independent living facilities in close geographic proximity. Participants meeting the inclusion/exclusion criteria have been randomized to either brief daily exposure to LMMS on a vibrating platform or a placebo platform over a three year period. All participants receive 1000 mg of elemental calcium and 800 IU of vitamin D per day.

This study will provide new and important information about the role of low magnitude high frequency mechanical stimulation on the skeleton.

Conditions

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Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low magnitude mechanical stimulation

10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz

Group Type EXPERIMENTAL

Low magnitude mechanical stimulation

Intervention Type DEVICE

10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz

2

10 minutes per day standing on sham low mechanical stimulation platform

Group Type PLACEBO_COMPARATOR

Sham low magnitude mechanical stimulation

Intervention Type DEVICE

10 minutes per day of low magnitude mechanical stimulation using a sham vibrating platform

Interventions

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Low magnitude mechanical stimulation

10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz

Intervention Type DEVICE

Sham low magnitude mechanical stimulation

10 minutes per day of low magnitude mechanical stimulation using a sham vibrating platform

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Men and women 60 years and over of all ethnic groups
* Weight less than 250 pounds
* Absence of terminal cancer or other illness necessitating hospice level services
* Capable of following the protocol and of understanding and providing informed consent
* Scoring less than 12 on the Short Blessed Test

Exclusion Criteria

* Immobilization of the axial or lower appendicular skeleton within the last year
* Nonambulatory (ambulation with an assistive device will be permitted)
* Malignancy other than cured thyroid cancer or skin cancer
* Hip replacement or internal fixation, total knee replacement, or lower limb fracture within the past year, or bilateral hip replacement
* Medications: glucocorticoids, suppressive doses of thyroid hormone as determined by screening TSH, anticonvulsant drugs (phenytoin, phenobarbital, carbamazepine), estrogen/testosterone replacement, selective estrogen receptor modulators (SERMs), PTH, or bisphosphonates more than 1 month in past year, calcitonin therapy within the preceding month, fluoride therapy at any time
* Paget's disease of bone, rheumatoid arthritis or other connective tissue disorders requiring systemic treatment with disease modifying drugs, or a history of Cushing's syndrome
* Fragility fracture within the past five years unless pharmacologic therapy not to be prescribed

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes