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

Study Overview
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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.

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.

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

Conditions
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Osteopenia

Intervention / Treatment
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* Device: Low magnitude mechanical stimulation
* Device: Sham low magnitude mechanical stimulation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low magnitude mechanical stimulation<br>10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz | Device: Low magnitude mechanical stimulation<br>* 10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz<br>|
| Placebo Comparator: 2<br>10 minutes per day standing on sham low mechanical stimulation platform | Device: Sham low magnitude mechanical stimulation<br>* 10 minutes per day of low magnitude mechanical stimulation using a sham vibrating platform<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan) |  | 2 - 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 2 - 3 years | 
| Changes in postural stability | Postural stability measured as quiet stance with eyes open for 4 minutes on a Kistler force platform | 2 - 3 years | 
| Changes in isometric leg extension strength | Isometric knee extension strength of the right leg measured with a handheld dynamometer | 2 - 3 years | 
| Change in hip muscle area and density | Muscle area and density surrounding the hips measured by quantitative computed tomography | 2 - 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomechanics, osteogenesis, osteoporosis, bone regeneration