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dc.contributor.authorKiel, Douglas P.
dc.contributor.authorHannan, Marian T.
dc.contributor.authorBarton, Bruce A.
dc.contributor.authorBouxsein, Mary L.
dc.contributor.authorLang, Thomas F.
dc.contributor.authorBrown, Kathleen M.
dc.contributor.authorShane, Elizabeth
dc.contributor.authorMagaziner, Jay
dc.contributor.authorZimmerman, Sheryl
dc.contributor.authorRubin, Clinton T.
dc.date2022-08-11T08:10:44.000
dc.date.accessioned2022-08-23T17:18:20Z
dc.date.available2022-08-23T17:18:20Z
dc.date.issued2010-06-24
dc.date.submitted2011-01-27
dc.identifier.citationClin Trials. 2010 Aug;7(4):354-67. Epub 2010 Jun 22. <a href="http://dx.doi.org/10.1177/1740774510371014">Link to article on publisher's site</a>
dc.identifier.issn1740-7745 (Linking)
dc.identifier.doi10.1177/1740774510371014
dc.identifier.pmid20571129
dc.identifier.urihttp://hdl.handle.net/20.500.14038/47832
dc.description.abstractBACKGROUND: Osteoporosis is a common complication of aging. Alternatives to pharmacologic treatment are needed for older adults. Nonpharmacologic treatment with low magnitude, high frequency mechanical stimulation has been shown to prevent bone loss in animal and human studies. METHODS: The VIBES (Vibration to Improve Bone Density in Elderly Subjects) study is a randomized, double-blind, sham-controlled trial of the efficacy of low magnitude, high frequency mechanical stimulation in 200 men and women aged 60 years and older with bone mineral density T-scores by dual X-ray absorptiometry between -1 and -2.5 at entry. Participants are healthy, cognitively intact residents of independent living communities in the Boston area who receive free calcium and Vitamin D supplements. They are randomly assigned to active or sham treatment and stand on their assigned platform once daily for 10 min. All platforms have adherence data collection software downloadable to a laptop computer. Adverse events are closely monitored. 174 participants were randomized and will be followed for 2 years. Almost all active subjects have attained 1 year of follow-up. Bone mineral density is measured by both dual X-ray absorptiometry and quantitative computed tomography at baseline and annually. The main analysis will compare mean changes from baseline in volumetric bone density by quantitative computed tomography in active and sham groups. Adherence and treatment effect magnitude will also be evaluated. Secondary analyses will compare changes in two biochemical markers of bone turnover as well as longitudinal comparisons of muscle and balance endpoints. RESULTS: The VIBES trial has completed its first year of data collection and encountered multiple challenges leading to valuable lessons learned about the areas of recruitment from independent living communities, deployment of multiuser mechanical devices using radio frequency identification cards and electronic adherence monitoring, organization of transportation for imaging at a central site, and the expansion of study aims to include additional musculoskeletal outcomes. CONCLUSIONS: These lessons will guide future investigations in studies of individuals of advanced age.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=20571129&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttp://dx.doi.org/10.1177/1740774510371014
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectBiological Markers
dc.subjectBone Density
dc.subjectCalcium
dc.subjectDietary Supplements
dc.subject*Equipment and Supplies
dc.subjectFemale
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectOsteoporosis
dc.subjectPatient Compliance
dc.subjectPostural Balance
dc.subjectResearch Design
dc.subjectVibration
dc.subjectVitamin D
dc.subjectBioinformatics
dc.subjectBiostatistics
dc.subjectEpidemiology
dc.subjectHealth Services Research
dc.titleInsights from the conduct of a device trial in older persons: low magnitude mechanical stimulation for musculoskeletal health
dc.typeJournal Article
dc.source.journaltitleClinical trials (London, England)
dc.source.volume7
dc.source.issue4
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/qhs_pp/946
dc.identifier.contextkey1749253
html.description.abstract<p>BACKGROUND: Osteoporosis is a common complication of aging. Alternatives to pharmacologic treatment are needed for older adults. Nonpharmacologic treatment with low magnitude, high frequency mechanical stimulation has been shown to prevent bone loss in animal and human studies.</p> <p>METHODS: The VIBES (Vibration to Improve Bone Density in Elderly Subjects) study is a randomized, double-blind, sham-controlled trial of the efficacy of low magnitude, high frequency mechanical stimulation in 200 men and women aged 60 years and older with bone mineral density T-scores by dual X-ray absorptiometry between -1 and -2.5 at entry. Participants are healthy, cognitively intact residents of independent living communities in the Boston area who receive free calcium and Vitamin D supplements. They are randomly assigned to active or sham treatment and stand on their assigned platform once daily for 10 min. All platforms have adherence data collection software downloadable to a laptop computer. Adverse events are closely monitored. 174 participants were randomized and will be followed for 2 years. Almost all active subjects have attained 1 year of follow-up. Bone mineral density is measured by both dual X-ray absorptiometry and quantitative computed tomography at baseline and annually. The main analysis will compare mean changes from baseline in volumetric bone density by quantitative computed tomography in active and sham groups. Adherence and treatment effect magnitude will also be evaluated. Secondary analyses will compare changes in two biochemical markers of bone turnover as well as longitudinal comparisons of muscle and balance endpoints.</p> <p>RESULTS: The VIBES trial has completed its first year of data collection and encountered multiple challenges leading to valuable lessons learned about the areas of recruitment from independent living communities, deployment of multiuser mechanical devices using radio frequency identification cards and electronic adherence monitoring, organization of transportation for imaging at a central site, and the expansion of study aims to include additional musculoskeletal outcomes.</p> <p>CONCLUSIONS: These lessons will guide future investigations in studies of individuals of advanced age.</p>
dc.identifier.submissionpathqhs_pp/946
dc.contributor.departmentDepartment of Quantitative Health Sciences
dc.source.pages354-67


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