Electromagnetic Treatment For Bone Loss After Forearm Fracture (NCT00067834) | Clinical Trial Compass
CompletedPhase 1/2
Electromagnetic Treatment For Bone Loss After Forearm Fracture
United States80 participantsStarted 2003-11
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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
Trial details
NCT IDNCT00067834
SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)