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| Tracking Information | |||||
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| First Received Date ICMJE | August 28, 2003 | ||||
| Last Updated Date | March 27, 2007 | ||||
| Start Date ICMJE | November 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00067834 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Electromagnetic Treatment For Bone Loss After Forearm Fracture | ||||
| Official Title ICMJE | Feasibility and Dosing Study of Bone Density Changes With and Without PEMF Following Immobilization of the Forearm | ||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Device: Pulsing electromagnetic field (PEMF) | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 80 | ||||
| Completion Date | October 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00067834 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | N01 AR32267, NIAMS-091 | ||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | March 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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