Electromagnetic Treatment For Bone Loss After Forearm Fracture
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|ClinicalTrials.gov Identifier: NCT00067834|
Recruitment Status : Completed
First Posted : September 1, 2003
Last Update Posted : December 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bone Disease, Metabolic Osteopenia Osteoporosis, Post-Traumatic||Device: Pulsing electromagnetic field (PEMF)||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Feasibility and Dosing Study of Bone Density Changes With and Without PEMF Following Immobilization of the Forearm|
|Study Start Date :||November 2003|
|Study Completion Date :||October 2006|
- Changes in bone density and geometry relative to baseline in the PEMF treated forearm during the 24 weeks after immobilization, as compared to the same changes in those receiving sham control treatment
- Changes in chemical markers of bone remodeling in the blood of PEMF treated versus sham control subjects
- bone density and structural changes in the 24 weeks after immobilization, measured by comparing the treated versus the contralateral forearms in subjects receiving PEMF or sham treatment
- influence of age, gender, and other factors
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067834
|United States, New York|
|Institute for Human Performance/Upstate Medical University|
|Syracuse, New York, United States, 13210|
|Principal Investigator:||Joseph A. Spadaro, PhD||Upstate Medical University Orthopedic Research Lab|