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

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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

Tracking Information
First Submitted Date  ICMJE November 7, 2006
First Posted Date  ICMJE November 8, 2006
Last Update Posted Date March 20, 2013
Study Start Date  ICMJE February 2007
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan) [ Time Frame: 2 - 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2006)
  • Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography
  • (CT scan)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2012)
  • 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 [ Time Frame: 2 - 3 years ]
    Postural stability measured as quiet stance with eyes open for 4 minutes on a Kistler force platform
  • Changes in isometric leg extension strength [ Time Frame: 2 - 3 years ]
    Isometric knee extension strength of the right leg measured with a handheld dynamometer
  • Change in hip muscle area and density [ Time Frame: 2 - 3 years ]
    Muscle area and density surrounding the hips measured by quantitative computed tomography
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2006)
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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE "VIBES"--Low Magnitude Mechanical Stimulation to Improve Bone Mineral Density
Official Title  ICMJE Low Magnitude Mechanical Stimulation (LMMS) to Improve Bone Mineral Density (BMD)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Osteopenia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Device: Low magnitude mechanical stimulation
  • Placebo Comparator: 2
    10 minutes per day standing on sham low mechanical stimulation platform
    Intervention: Device: Sham low magnitude mechanical stimulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2013)
174
Original Enrollment  ICMJE
 (submitted: November 7, 2006)
200
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00396994
Other Study ID Numbers  ICMJE AG0071
R01AG025489 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Douglas Kiel, Hebrew SeniorLife
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Hebrew SeniorLife
Original Study Sponsor  ICMJE National Institute on Aging (NIA)
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
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
PRS Account Hebrew SeniorLife
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP