Osteopenia Clinical Trial
Official title:
Feasibility and Dosing Study of Bone Density Changes With and Without PEMF Following Immobilization of the Forearm
This study will determine the usefulness of pulsing electromagnetic field (PEMF) technology to reverse or reduce the bone loss (osteopenia) that occurs in the forearm after fracture or surgery.
The long-range goal of this research is to develop a new and supplementary local treatment
for osteoporosis to reduce the risk of fracture in susceptible individuals. PEMF is a
noninvasive method to magnetically introduce a small amount of electrical current to a
specific bone region to stimulate bone formation. PEMFs have been used for many years to
treat nonunited fractures and enhance spine fusion healing and have been found to improve
bone density in animal models of osteoporosis. Such a noninvasive intervention applied to
the hip or spine, which are especially associated with high morbidity and mortality in aging
individuals, could have a significant national health care impact.
If effective for the treatment of bone loss, PEMF technology may be effective in treating
osteoporosis. The primary objective of this pilot study is to determine the feasibility of
using PEMFs to reverse or reduce bone loss that occurs with disuse of the forearm after
fracture or surgery and to determine the effect of daily treatment duration on efficacy.
Eighty patients who have recently undergone immobilization after hand surgery or after lower
forearm fracture will be enrolled in this study. Participants will be randomized to either
the PEMF group or a control group. PEMFs will be administered by means of a magnetic coil
transducer placed over the treatment site for 1, 2, or 4 hrs/day for 8 weeks, beginning 6
weeks after the initial injury or surgery. A self-contained, battery-powered PEMF coil
transducer already FDA-approved for fracture healing in the forearm will be used.
Participants in the control group will receive inactive but otherwise identical units and
treatment times. Measurements of bone density will be made using DEXA (dual energy x-ray
absorptiometry) and pQCT (peripheral quantitative computer tomography) and compared to
baseline. DEXA and pQCT provide planar and cross-sectional x-ray densitometry to determine
forearm bone changes. Bone densities (global, cortical, and trabecular), bone
cross-sectional structural geometry, and calculated strength index will be measured and
compared to baseline values.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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