The purpose of this study is to determine if daily low magnitude, high frequency whole body vibration can improve bone density in seniors.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
174
10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz
10 minutes per day of low magnitude mechanical stimulation using a sham vibrating platform
Hebrew SeniorLife, Institute for Aging Research
Boston, Massachusetts, United States
Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan)
Time frame: 2 - 3 years
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)
Time frame: 2 - 3 years
Changes in postural stability
Postural stability measured as quiet stance with eyes open for 4 minutes on a Kistler force platform
Time frame: 2 - 3 years
Changes in isometric leg extension strength
Isometric knee extension strength of the right leg measured with a handheld dynamometer
Time frame: 2 - 3 years
Change in hip muscle area and density
Muscle area and density surrounding the hips measured by quantitative computed tomography
Time frame: 2 - 3 years
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