Establishing the compliance in elderly women for use of a low level mechanical stress device in a clinical osteoporosis study
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Non-pharmacologic approaches to prevent bone loss are well suited for elderly patients to avoid polypharmacy and medication side effects. One potential treatment is a vibrating platform that delivers low-level mechanical loading stimulating bone remodeling. However, compliance is a major concern with any daily treatment, and is unknown for an elderly group using this device. Thus we assessed compliance with standing 10 min/day on a vibrating platform device in elderly women, the target population for osteoporosis therapy. We also assessed satisfaction with daily use of the device. We conducted a randomized, placebo-controlled, double-blinded 6-month study for daily use of a 10-min vibrating platform treatment in elderly women who were residents of a Continuing Care Retirement community. Compliance for each subject was calculated as the number of days attended divided by the 182 days in the 6-month trial. The 24 elderly women (mean age 86, range 79–92 years) had 83% compliance (95% CI: 70.5, 94.5) for daily treatment over 6 months. Excluding three study drop-outs, the 21 women had 93% compliance (95% CI: 89.8, 95.6), with no difference in compliance between active and placebo treatment. Main reasons for missing treatment days over the 6 months were vacation (54% of missed days) and illness (29%). Three adverse events occurred; one (syncope) was possibly related to device use, whereas the other two were not related to device use. Among participants, 95% reported overall satisfaction with daily use of the vibrating platform, and 57% preferred the platform versus daily oral medications for prevention of bone loss. Elderly women showed high compliance, high satisfaction and few adverse experiences with a daily non-pharmacological treatment designed to inhibit bone loss. Larger randomized controlled trials should evaluate the long-term efficacy of vibrating platform devices for treatment of low bone mass and osteoporosis in elderly individuals.
KeywordsAging Bone Compliance Elderly Feasibility Osteoporosis Randomized controlled trial
We are grateful to the VIBES Study participants and staff at Orchard Cove and HRCA Research & Training Institute, especially the study interviewer, Barbara Hopkins, device monitor, Robert McLean, and programmer, Corinna Andiel. Thanks are extended to Jack Ryaby of Exogen, Inc. a subsidiary of Smith & Nephew, Inc., for the loan of the vibrating platform devices for this trial, and to Tommy Wilson, Joan McCabe and Roger Talish for technical support. This work was supported by grant RO1-AR47368 from the National Institute of Arthritis, Musculoskeletal and Skin Diseases, with equipment provided by Exogen, Inc., N.J., USA, a wholly owned subsidiary of Smith & Nephew Orthopaedics, Inc. USA. The clinical investigation described in this paper involves a non-significant risk device as defined by the Investigational Device Exemption Regulations of the United States Food and Drug Administration (FDA).
Presented in part as abstracts at the 2003 American Geriatrics Society meeting in Baltimore MD and International Bone Society Meetings in Osaka, Japan.
Dr. Clinton Rubin has served as a consultant for Smith & Nephew Orthopaedics, and is one of the inventors of the mechanical stress system technology.
Conflict of interest:
No information supplied.
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