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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Douglas Kiel, Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier:
NCT00396994
First received: November 7, 2006
Last updated: March 18, 2013
Last verified: March 2013

November 7, 2006
March 18, 2013
February 2007
June 2012   (final data collection date for primary outcome measure)
Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan) [ Time Frame: 2 - 3 years ] [ Designated as safety issue: No ]
  • Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography
  • (CT scan)
Complete list of historical versions of study NCT00396994 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Changes in postural stability [ Time Frame: 2 - 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Muscle area and density surrounding the hips measured by quantitative computed tomography
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)
Not Provided
Not Provided
 
"VIBES"--Low Magnitude Mechanical Stimulation to Improve Bone Mineral Density
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Osteopenia
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00396994
AG0071, R01AG025489
Yes
Douglas Kiel, Hebrew Rehabilitation Center, Boston
Hebrew Rehabilitation Center, Boston
National Institute on Aging (NIA)
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
Hebrew Rehabilitation Center, Boston
March 2013

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