Prevention of postmenopausal bone loss by a low-magnitude, high-frequency mechanical stimuli: A clinical trial assessing compliance, efficacy, and safety

Clinton T. Rubin, Robert R. Recker, Diane Cullen, John Ryaby, Joan McCabe, Kenneth McLeod

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Abstract

A 1-year prospective, randomized, double-blind, and placebo-controlled trial of 70 postmenopausal women demonstrated that brief periods (2 peak to peak), 30-Hz vertical accelerations (vibration), whereas the other half stood for the same duration on placebo devices. DXA was used to measure BMD at the spine, hip, and distal radius at baseline, and 3, 6, and 12 months. Fifty-six women completed the 1-year treatment. Results and Conclusions: The detection threshold of the study design failed to show any changes in bone density using an intention-to-treat analysis for either the placebo or treatment group. Regression analysis on the a priori study group demonstrated a significant effect of compliance on efficacy of the intervention, particularly at the lumbar spine (p = 0.004). Posthoc testing was used to assist in identifying various subgroups that may have benefited from this treatment modality. Evaluating those in the highest quarfile of compliance (86% compliant), placebo subjects lost 2.13% in the femoral neck over 1 year, whereas treatment was associated with a gain of 0.04%, reflecting a 2.17% relative benefit of treatment (p = 0.06). In the spine, the 1.6% decrease observed over 1 year in the placebo group was reduced to a 0.10% loss in the active group, indicating a 1.5% relative benefit of treatment (p = 0.09). Considering the interdependence of weight, the spine of lighter women (

Original languageEnglish
Pages (from-to)343-351
Number of pages9
JournalJournal of Bone and Mineral Research
Volume19
Issue number3
DOIs
StatePublished - Mar 2004

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Postmenopausal Osteoporosis
Compliance
Clinical Trials
Safety
Placebos
Spine
Therapeutics
Intention to Treat Analysis
Femur Neck
Vibration
Bone Density
Hip
Regression Analysis
Weights and Measures
Equipment and Supplies

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Prevention of postmenopausal bone loss by a low-magnitude, high-frequency mechanical stimuli : A clinical trial assessing compliance, efficacy, and safety. / Rubin, Clinton T.; Recker, Robert R.; Cullen, Diane; Ryaby, John; McCabe, Joan; McLeod, Kenneth.

In: Journal of Bone and Mineral Research, Vol. 19, No. 3, 03.2004, p. 343-351.

Research output: Contribution to journalArticle

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