Trials / Completed
CompletedNCT00396994
"VIBES"--Low Magnitude Mechanical Stimulation to Improve Bone Mineral Density
Low Magnitude Mechanical Stimulation (LMMS) to Improve Bone Mineral Density (BMD)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 174 (actual)
- Sponsor
- Hebrew SeniorLife · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine if daily low magnitude, high frequency whole body vibration can improve bone density in seniors.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 |
| DEVICE | Sham low magnitude mechanical stimulation | 10 minutes per day of low magnitude mechanical stimulation using a sham vibrating platform |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2006-11-08
- Last updated
- 2013-03-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00396994. Inclusion in this directory is not an endorsement.