"VIBES"--Low Magnitude Mechanical Stimulation to Improve Bone Mineral Density

Hebrew SeniorLife

Status

Completed

Conditions

Osteopenia

Treatments

Device: Sham low magnitude mechanical stimulation

Device: Low magnitude mechanical stimulation

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00396994

R01AG025489 (U.S. NIH Grant/Contract)

AG0071

Details and patient eligibility

About

The purpose of this study is to determine if daily low magnitude, high frequency whole body vibration can improve bone density in seniors.

Full description

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) by preventing bone resorption due to disuse and aging, and can stimulate new bone formation.

To confirm and extend these observations, this study is a three-year, double-blind, randomized, placebo-controlled clinical trial of LMMS in 200 elderly women and men (60 years of age and older). A clinical center located in Boston, MA has recruited participants from multiple independent living facilities in close geographic proximity. Participants meeting the inclusion/exclusion criteria have been randomized to either brief daily exposure to LMMS on a vibrating platform or a placebo platform over a three year period. All participants receive 1000 mg of elemental calcium and 800 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.

Enrollment

174 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Men and women 60 years and over of all ethnic groups
Weight less than 250 pounds
Absence of terminal cancer or other illness necessitating hospice level services
Capable of following the protocol and of understanding and providing informed consent
Scoring less than 12 on the Short Blessed Test

Exclusion criteria

Immobilization of the axial or lower appendicular skeleton within the last year
Nonambulatory (ambulation with an assistive device will be permitted)
Malignancy other than cured thyroid cancer or skin cancer
Hip replacement or internal fixation, total knee replacement, or lower limb fracture within the past year, or bilateral hip replacement
Medications: glucocorticoids, suppressive doses of thyroid hormone as determined by screening TSH, anticonvulsant drugs (phenytoin, phenobarbital, carbamazepine), estrogen/testosterone replacement, selective estrogen receptor modulators (SERMs), PTH, or bisphosphonates more than 1 month in past year, calcitonin therapy within the preceding month, fluoride therapy at any time
Paget's disease of bone, rheumatoid arthritis or other connective tissue disorders requiring systemic treatment with disease modifying drugs, or a history of Cushing's syndrome
Fragility fracture within the past five years unless pharmacologic therapy not to be prescribed