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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00396994 |
The purpose of this study is to determine if daily low magnitude, high frequency whole body vibration can improve bone density in seniors.
Condition | Intervention | Phase |
---|---|---|
Low Bone Density |
Device: Low magnitude high frequency whole body vibration |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Low Magnitude Mechanical Stimulation (LMMS) to Improve Bone Mineral Density (BMD) |
Estimated Enrollment: | 200 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | March 2010 |
The treatment options for osteoporosis, a major health complication in the aged population, are limited to pharmacologic interventions, the majority of which are antiresorptive. Preliminary data demonstrate that high frequency, low magnitude mechanical stimulation (LMMS) can preserve bone mineral density (BMD) against systemic pressures to resorb (e.g., disuse, aging), and can stimulate new bone formation.
To confirm and extend these observations, this study is a two-year, double-blind, randomized, placebo-controlled clinical trial of LMMS in 200 elderly women and men (65 years of age and older). A clinical center located in Boston, MA will recruit participants from six independent living facilities in close geographic proximity serving a population of 2,082 residents. Following a two-week trial run-in period with an inactive vibrating platform, participants meeting the inclusion/exclusion criteria will be randomized to either brief daily exposure to LMMS on a vibrating platform or a placebo platform over a two year period. All participants will receive 500 mg of elemental calcium and 400 IU of vitamin D per day.
This study will provide new and important information about the role of low magnitude high frequency mechanical stimulation on the skeleton.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Hebrew Senior Life, Institute for Aging Research | Recruiting |
Boston, Massachusetts, United States, 02131 | |
Contact: Judith P. Stone, MSW 617-363-8638 jstone@mail.hrca.harvard.edu | |
Contact: Dawn M. Dewkett, BS, RN 617-363-8829 dewkett@mail.hrca.harvard.edu |
Principal Investigator: | Douglas P. Kiel, MD, MPH | Institute for Aging Research, Hebrew Senior Life |
Principal Investigator: | Marian T. Hannan, DSc, MPH | Institute for Aging Research, Hebrew Senior Life |
Study ID Numbers: | AG0071, R01AG025489 |
Study First Received: | November 7, 2006 |
Last Updated: | September 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00396994 |
Health Authority: | United States: Federal Government |
biomechanics osteogenesis osteoporosis bone regeneration |
Osteoporosis |