Insights from the conduct of a device trial in older persons: low magnitude mechanical stimulation for musculoskeletal health.
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.


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.
Kiel
Douglas P
DP
Institute for Aging Research, Boston, MA, USA. kiel@hrca.harvard.edu
Hannan
Marian T
MT
Barton
Bruce A
BA
Bouxsein
Mary L
ML
Lang
Thomas F
TF
Brown
Kathleen M
KM
Shane
Elizabeth
E
Magaziner
Jay
J
Zimmerman
Sheryl
S
Rubin
Clinton T
CT
D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers; D015519:Bone Density; D002118:Calcium / Q000627:therapeutic use; D019587:Dietary Supplements; D004864:Equipment and Supplies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000628:therapy*; D010349:Patient Compliance; D004856:Postural Balance; D012107:Research Design; D014732:Vibration / Q000009:adverse effects / Q000627:therapeutic use*; D014807:Vitamin D / Q000627:therapeutic use
D015415:Biomarkers; D014807:Vitamin D; D002118:Calcium