Electromagnetic Treatment For Bone Loss After Forearm Fracture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bone Disease, Metabolic Osteopenia Osteoporosis, Post-Traumatic

Keywords

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Electromagnetic Fields Bone Forelimb Radius

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pulsing electromagnetic field (PEMF)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Treatment and immobilization for carpal instability or repair or a lower forearm fracture (Colles' or Smith's) within 6 weeks
* Intact, normal prior skeletal anatomy and function in both arms

Exclusion Criteria

* Previous forearm fracture (either arm), orthopedic procedure, or forearm deformity which might affect forearm bone density
* History of renal disease, liver disease, diabetes, hyperthyroidism, hyperparathyroidism, Cushing's disease, uncontrolled seizures, rheumatoid arthritis, Paget's disease, multiple myeloma, or hypothyroidism
* Implanted cardiac pacemakers or defibrillators
* Pregnant
* Drug therapies within the previous 3 months that could affect bone (e.g., bisphosphonates, estrogen, progesterone, CaF2, calcitonin, steroids, anti-seizure medications)
* Difficulties complying with the protocol due to physical or mental inability, drug or alcohol abuse, psychosis or dementia, imprisonment, or unavailable for follow-up
* History of osteoporosis, as defined by a DEXA T-score of more than 2 standard deviations below normal in the hip, spine, or unaffected forearm
* Prior osteoporotic hip or vertebral fracture

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Joseph A. Spadaro, PhD

Role: PRINCIPAL_INVESTIGATOR

Upstate Medical University Orthopedic Research Lab

Locations

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Institute for Human Performance/Upstate Medical University

Syracuse, New York, United States

Site Status

Countries

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United States

Other Identifiers

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NIAMS-091

Identifier Type: -

Identifier Source: secondary_id

N01 AR32267