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

Primary Purpose

Osteopenia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Low magnitude mechanical stimulation

Sham low magnitude mechanical stimulation

About this trial

This is an interventional prevention trial for Osteopenia focused on measuring biomechanics, osteogenesis, osteoporosis, bone regeneration

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hebrew SeniorLife, Institute for Aging Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Low magnitude mechanical stimulation

Arm Description

10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz

10 minutes per day standing on sham low mechanical stimulation platform

Outcomes

Primary Outcome Measures

Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan)

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)

Changes in postural stability

Postural stability measured as quiet stance with eyes open for 4 minutes on a Kistler force platform

Changes in isometric leg extension strength

Isometric knee extension strength of the right leg measured with a handheld dynamometer

Change in hip muscle area and density

Muscle area and density surrounding the hips measured by quantitative computed tomography

Full Information

NCT ID

NCT00396994

First Posted

November 7, 2006

Last Updated

March 18, 2013

Sponsor

Hebrew SeniorLife

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT00396994

Brief Title

"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

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hebrew SeniorLife

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteopenia

Keywords

biomechanics, osteogenesis, osteoporosis, bone regeneration

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

174 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low magnitude mechanical stimulation

Arm Type

Experimental

Arm Description

10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz

Arm Title

Arm Type

Placebo Comparator

Arm Description

10 minutes per day standing on sham low mechanical stimulation platform

Intervention Type

Device

Intervention Name(s)

Low magnitude mechanical stimulation

Intervention Description

10 minutes per day of low magnitude mechanical stimulation using a vibrating platform set at 0.3 g and 30 Hz

Intervention Type

Device

Intervention Name(s)

Sham low magnitude mechanical stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in volumetric trabecular BMD of the spine and hip by quantitative computed tomography (CT scan)

Time Frame

2 - 3 years

Secondary Outcome Measure Information:

Title

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

Title

Changes in postural stability

Description

Postural stability measured as quiet stance with eyes open for 4 minutes on a Kistler force platform

Time Frame

2 - 3 years

Title

Changes in isometric leg extension strength

Description

Isometric knee extension strength of the right leg measured with a handheld dynamometer

Time Frame

2 - 3 years

Title

Change in hip muscle area and density

Description

Muscle area and density surrounding the hips measured by quantitative computed tomography

Time Frame

2 - 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Douglas P. Kiel, MD, MPH

Organizational Affiliation

Institute for Aging Research, Hebrew SeniorLife

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marian T. Hannan, DSc, MPH

Organizational Affiliation

Institute for Aging Research, Hebrew SeniorLife

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hebrew SeniorLife, Institute for Aging Research

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02131

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15040823

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.

Results Reference

background

PubMed Identifier

15040821

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.

Results Reference

background

PubMed Identifier

16939405

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.

Results Reference

background

PubMed Identifier

20571129

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.

Results Reference

background

PubMed Identifier

23940592

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.

Results Reference

derived

PubMed Identifier

23150931

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.

Results Reference

derived

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

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