"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
  Purpose

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


Condition Intervention
Osteopenia
Device: Low magnitude mechanical stimulation
Device: Sham low magnitude mechanical stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Low Magnitude Mechanical Stimulation (LMMS) to Improve Bone Mineral Density (BMD)

Resource links provided by NLM:


Further study details as provided by Hebrew Rehabilitation Center, Boston:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 174
Study Start Date: February 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396994

Locations
United States, Massachusetts
Hebrew SeniorLife, Institute for Aging Research
Boston, Massachusetts, United States, 02131
Sponsors and Collaborators
Hebrew Rehabilitation Center, Boston
Investigators
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas Kiel, Director Musculoskeletal Research Center, Hebrew Rehabilitation Center, Boston
ClinicalTrials.gov Identifier: NCT00396994     History of Changes
Other Study ID Numbers: AG0071, R01AG025489
Study First Received: November 7, 2006
Last Updated: March 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Hebrew Rehabilitation Center, Boston:
biomechanics
osteogenesis
osteoporosis
bone regeneration

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 31, 2014