Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00067834
Study type Interventional
Source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Contact
Status Completed
Phase Phase 1/Phase 2
Start date November 2003
Completion date October 2006

See also
  Status Clinical Trial Phase
Recruiting NCT04754711 - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition N/A
Active, not recruiting NCT05066477 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Bone Mass Among Osteopenic Women N/A
Terminated NCT01902186 - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir Phase 4
Not yet recruiting NCT01397838 - Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women Phase 1
Completed NCT01439139 - Bone UltraSonic Scanner (BUSS): Validation Study N/A
Completed NCT01222026 - Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate Phase 4
Completed NCT01152580 - Melatonin Osteoporosis Prevention Study Phase 1
Completed NCT00789425 - Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women Phase 2
Completed NCT00463268 - Osteoporosis Prevention With Low Dose Alendronate Phase 3
Completed NCT00655681 - Prevention of Post Operative Bone Loss in Children N/A
Completed NCT00798473 - Zoledronate for Osteopenia in Pediatric Crohn's Phase 3
Active, not recruiting NCT00076050 - Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms Phase 3
Completed NCT00226031 - Optimal Management of Women With Wrist Fractures N/A
Enrolling by invitation NCT04752098 - A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method N/A
Completed NCT04720833 - Effect of Dried Plum on Bone and Markers of Bone Status in Men N/A
Recruiting NCT05541432 - Finding the Optimal Resistance Training Intensity For Your Bones N/A
Active, not recruiting NCT05405894 - Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Completed NCT05457036 - Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile N/A
Completed NCT04040010 - The Effects of Bovine Colostrum in Bone Metabolism in Humans N/A
Completed NCT02731820 - Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia N/A