Electromagnetic Treatment For Bone Loss After Forearm Fracture

NCT00067834 | Completed Phase 1

• 2 other identifiers: N01 AR32267NIAMS-091
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Disease, Metabolic; Osteopenia; Osteoporosis, Post-Traumatic

Keywords

Electromagnetic Fields; Bone; Forelimb; Radius

Outcome Measures

Primary Outcomes (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

Secondary Outcomes (3)

• 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

Interventions

Pulsing electromagnetic field (PEMF) DEVICE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

Institute for Human Performance/Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Joseph A. Spadaro, PhD

  Upstate Medical University Orthopedic Research Lab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 28, 2003
• First Posted: September 1, 2003
• Study Start: November 1, 2003
• Study Completion: October 1, 2006
• Last Updated: December 23, 2015

Record last verified: 2015-12

Locations

US (1)