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

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:

MedlinePlus related topics: Bone Density Minerals

U.S. FDA Resources

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

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

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

More Information

Publications:

Ward K, Alsop C, Caulton J, Rubin C, Adams J, Mughal Z. Low magnitude mechanical loading is osteogenic in children with disabling conditions. J Bone Miner Res. 2004 Mar;19(3):360-9. Epub 2004 Jan 27.

Rubin C, Recker R, Cullen D, Ryaby J, McCabe J, McLeod K. Prevention of postmenopausal bone loss by a low-magnitude, high-frequency mechanical stimuli: a clinical trial assessing compliance, efficacy, and safety. J Bone Miner Res. 2004 Mar;19(3):343-51. Epub 2003 Dec 22.

Gilsanz V, Wren TA, Sanchez M, Dorey F, Judex S, Rubin C. Low-level, high-frequency mechanical signals enhance musculoskeletal development of young women with low BMD. J Bone Miner Res. 2006 Sep;21(9):1464-74.

Kiel DP, Hannan MT, Barton BA, Bouxsein ML, Lang TF, Brown KM, Shane E, Magaziner J, Zimmerman S, Rubin CT. Insights from the conduct of a device trial in older persons: low magnitude mechanical stimulation for musculoskeletal health. Clin Trials. 2010;7(4):354-67. Epub 2010 Jun 22.

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

Jeffrey BA, Hannan MT, Quinn EK, Zimmerman S, Barton BA, Rubin CT, Kiel DP. Self-reported adherence with the use of a device in a clinical trial as validated by electronic monitors: the VIBES study. BMC Med Res Methodol. 2012 Nov 14;12:171. doi: 10.1186/1471-2288-12-171.

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 June 18, 2013