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

March 18, 2013 updated by: Douglas Kiel, Hebrew SeniorLife

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Hebrew SeniorLife, Institute for Aging Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan)
Time Frame: 2 - 3 years
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)
Time Frame: 2 - 3 years
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
2 - 3 years
Changes in isometric leg extension strength
Time Frame: 2 - 3 years
Isometric knee extension strength of the right leg measured with a handheld dynamometer
2 - 3 years
Change in hip muscle area and density
Time Frame: 2 - 3 years
Muscle area and density surrounding the hips measured by quantitative computed tomography
2 - 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebrew SeniorLife

Collaborators

National Institute on Aging (NIA)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 7, 2006

First Submitted That Met QC Criteria

November 7, 2006

First Posted (Estimate)

November 8, 2006

Study Record Updates

Last Update Posted (Estimate)

March 20, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0071
  • R01AG025489 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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