Osteopenia Clinical Trial
Official title:
Low Magnitude Mechanical Stimulation (LMMS) to Improve Bone Mineral Density (BMD)
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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