Osteopenia Clinical Trial
Official title:
Feasibility and Dosing Study of Bone Density Changes With and Without PEMF Following Immobilization of the Forearm
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | October 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Institute for Human Performance/Upstate Medical University | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Changes in chemical markers of bone remodeling in the blood of PEMF treated versus sham control subjects | |||
Secondary | 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 | |||
Secondary | influence of age, gender, and other factors |
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 | |
Completed |
NCT01439139 -
Bone UltraSonic Scanner (BUSS): Validation Study
|
N/A | |
Not yet recruiting |
NCT01397838 -
Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women
|
Phase 1 | |
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 |
NCT00655681 -
Prevention of Post Operative Bone Loss in Children
|
N/A | |
Completed |
NCT00463268 -
Osteoporosis Prevention With Low Dose Alendronate
|
Phase 3 | |
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 |