Establishing the compliance in elderly women for use of a low level mechanical stress device in a clinical osteoporosis study.

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.

RCT Entities:   Population Interventions Outcomes