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

Osteopenia Clinical Trial

Official title:

Low Magnitude Mechanical Stimulation (LMMS) to Improve Bone Mineral Density (BMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396994
• Other study ID #: AG0071
• Secondary ID: R01AG025489
• Status: Completed
• Phase: N/A
• First received: November 7, 2006
• Last updated: March 18, 2013
• Start date: February 2007
• Est. completion date: June 2012

Study information

• Verified date: March 2013
• Source: Hebrew Rehabilitation Center, Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteopenia

Intervention

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
• Sham low magnitude mechanical stimulation
10 minutes per day of low magnitude mechanical stimulation using a sham vibrating platform

Locations

Country	Name	City	State
United States	Hebrew SeniorLife, Institute for Aging Research	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Hebrew Rehabilitation Center, Boston	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. Epub 2003 Dec 22. — View 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. Epub 2004 Jan 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan)		2 - 3 years	No
Secondary	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)		2 - 3 years	No
Secondary	Changes in postural stability	Postural stability measured as quiet stance with eyes open for 4 minutes on a Kistler force platform	2 - 3 years	No
Secondary	Changes in isometric leg extension strength	Isometric knee extension strength of the right leg measured with a handheld dynamometer	2 - 3 years	No
Secondary	Change in hip muscle area and density	Muscle area and density surrounding the hips measured by quantitative computed tomography	2 - 3 years	No