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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00396994
Recruitment Status : Completed
First Posted : November 8, 2006
Last Update Posted : March 20, 2013
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Douglas Kiel, Hebrew SeniorLife

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

Condition or disease Intervention/treatment Phase
Osteopenia Device: Low magnitude mechanical stimulation Device: Sham low magnitude mechanical stimulation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Low Magnitude Mechanical Stimulation (LMMS) to Improve Bone Mineral Density (BMD)
Study Start Date : February 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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: 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
Placebo Comparator: 2
10 minutes per day standing on sham low mechanical stimulation platform
 Device: Sham low magnitude mechanical stimulation
10 minutes per day of low magnitude mechanical stimulation using a sham vibrating platform


Outcome Measures
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Primary Outcome Measures :
  1. Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan) [ Time Frame: 2 - 3 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Changes in postural stability [ Time Frame: 2 - 3 years ]
    Postural stability measured as quiet stance with eyes open for 4 minutes on a Kistler force platform

  3. Changes in isometric leg extension strength [ Time Frame: 2 - 3 years ]
    Isometric knee extension strength of the right leg measured with a handheld dynamometer

  4. Change in hip muscle area and density [ Time Frame: 2 - 3 years ]
    Muscle area and density surrounding the hips measured by quantitative computed tomography


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396994


Locations
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United States, Massachusetts
Hebrew SeniorLife, Institute for Aging Research
Boston, Massachusetts, United States, 02131
Sponsors and Collaborators
Hebrew SeniorLife
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Douglas P. Kiel, MD, MPH Institute for Aging Research, Hebrew SeniorLife
Principal Investigator: Marian T. Hannan, DSc, MPH Institute for Aging Research, Hebrew SeniorLife
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Douglas Kiel, Director Musculoskeletal Research Center, Hebrew SeniorLife
ClinicalTrials.gov Identifier: NCT00396994    
Other Study ID Numbers: AG0071
R01AG025489 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2006    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013
Keywords provided by Douglas Kiel, Hebrew SeniorLife:
biomechanics
osteogenesis
osteoporosis
bone regeneration
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases