NCT00396994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 20, 2013

Status Verified

March 1, 2013

Enrollment Period

5.3 years

First QC Date

November 7, 2006

Last Update Submit

March 18, 2013

Conditions

Osteopenia

Keywords

biomechanicsosteogenesisosteoporosisbone regeneration

Outcome Measures

Primary Outcomes (1)

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

    2 - 3 years

Secondary Outcomes (4)

  • 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

  • Changes in postural stability

    2 - 3 years

  • Changes in isometric leg extension strength

    2 - 3 years

  • Change in hip muscle area and density

    2 - 3 years

Study Arms (2)

Low magnitude mechanical stimulation

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

10 minutes per day standing on sham low mechanical stimulation platform

Device: Sham low magnitude mechanical stimulation

Interventions

Low magnitude mechanical stimulationDEVICE

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

Low magnitude mechanical stimulation
Sham low magnitude mechanical stimulationDEVICE

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

2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew SeniorLife, Institute for Aging Research

Boston, Massachusetts, 02131, United States

Location

Related Publications (6)

  • 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.

    PMID: 15040823BACKGROUND

  • 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.

    PMID: 15040821BACKGROUND

  • 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.

    PMID: 16939405BACKGROUND

  • 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.

    PMID: 20571129BACKGROUND

  • 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.

    PMID: 23940592DERIVED

  • 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.

    PMID: 23150931DERIVED

MeSH Terms

Conditions

Bone Diseases, MetabolicOsteoporosis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Douglas P. Kiel, MD, MPH

    Institute for Aging Research, Hebrew SeniorLife

    PRINCIPAL INVESTIGATOR

  • Marian T. Hannan, DSc, MPH

    Institute for Aging Research, Hebrew SeniorLife

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Musculoskeletal Research Center

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 8, 2006

Study Start

February 1, 2007

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 20, 2013

Record last verified: 2013-03

Locations

US(1)