Clinical trial NCT00396994: "VIBES"--Low Magnitude Mechanical Stimulation to Improve Bone Mineral Density
Official title: Low Magnitude Mechanical Stimulation (LMMS) to Improve Bone Mineral Density (BMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Keywords: biomechanics
osteogenesis
osteoporosis
bone regeneration
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2006-11-08
Enrollment: 174
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan)
timeFrame: 2 - 3 years
Secondary outcomes:
measure: 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)
timeFrame: 2 - 3 years
measure: Changes in postural stability
timeFrame: 2 - 3 years
measure: Changes in isometric leg extension strength
timeFrame: 2 - 3 years
measure: Change in hip muscle area and density
timeFrame: 2 - 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Hebrew SeniorLife, Institute for Aging Research
state: Massachusetts
Study officials:
affiliation: Institute for Aging Research, Hebrew SeniorLife
name: Douglas P. Kiel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Aging Research, Hebrew SeniorLife
name: Marian T. Hannan, DSc, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1359/JBMR.040129. Epub 2004 Jan 27.
citation: 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. doi: 10.1359/JBMR.0301251. Epub 2003 Dec 22.
citation: 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. doi: 10.1359/jbmr.060612.
citation: 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 Aug;7(4):354-67. doi: 10.1177/1740774510371014. Epub 2010 Jun 22.
citation: Muir JW, Kiel DP, Hannan M, Magaziner J, Rubin CT. Dynamic parameters of balance which correlate to elderly persons with a history of falls. PLoS One. 2013 Aug 5;8(8):e70566. doi: 10.1371/journal.pone.0070566. Print 2013.
citation: 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.