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

This study is currently recruiting participants.
Verified by National Institute on Aging (NIA) September 2007

Sponsored by:

National Institute on Aging (NIA)

Information provided by:

National Institute on Aging (NIA)

ClinicalTrials.gov Identifier:

NCT00396994

 

Purpose

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

Condition

Intervention

Phase

Low Bone Density

 Device: Low magnitude high frequency whole body vibration

Phase II

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Low Magnitude Mechanical Stimulation (LMMS) to Improve Bone Mineral Density (BMD)

Primary Outcome Measures: 

  • Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography
  • (CT scan)


Secondary Outcome Measures: 

  • Changes in biochemical markers of bone formation (Procollagen type 1 N-terminal peptide and Bone Specific Alkaline Phosphatase) and resorption (C-terminal Telopeptide of type I collagen)

Further study details as provided by National Institute on Aging (NIA):


Total Enrollment:  200

Study start: February 2007;  Expected completion: March 2010

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) against systemic pressures to resorb (e.g., disuse, aging), and can stimulate new bone formation.

To confirm and extend these observations, this study is a two-year, double-blind, randomized, placebo-controlled clinical trial of LMMS in 200 elderly women and men (65 years of age and older). A clinical center located in Boston, MA will recruit participants from six independent living facilities in close geographic proximity serving a population of 2,082 residents. Following a two-week trial run-in period with an inactive vibrating platform, participants meeting the inclusion/exclusion criteria will be randomized to either brief daily exposure to LMMS on a vibrating platform or a placebo platform over a two year period. All participants will receive 500 mg of elemental calcium and 400 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.

 

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