Long-term Effect of Electromagnetic Field in Treatment of Patients With Osteopenia or Osteoporosis

Study Overview
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Brief Summary
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Osteoporosis is the most prevalent metabolic bone disease. Although osteoporosis is widely considered to be much more prevalent in women approximately 39% of new osteoporotic fractures estimated to have occurred worldwide in 2000 were in men. A number of studies investigate the effect of physical therapy modalities in treatment of osteoporosis. The use of pulsed electromagnetic field (PEMF) represents an attractive alternative for osteoporosis. Previous studies suggested that pulsed electromagnetic field could be beneficial for increase bone mineral density in osteoporotic patients, but there is a lack of knowledge about the long term effect on several parameters.

Detailed Description
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Objectives: This randomized controlled study aims to investigate the long term effect of pulsed electromagnetic field (PEMF) on bone mineral density (BMD) and bone markers; also to be used as treatment intervention of osteopenia or osteoporosis through studying the effect of low intensity, low frequency, single pulsed electromagnetic fields. Methods: One hundred and twenty male patients with osteopenia or osteoporosis will participate in this study, their age ranges between 30-60 years. They have BMD T-scores ≤ - 1.5. All patients will be randomized into one of three groups. Group one received PEMF and exercise (PEMF+EX), group two received placebo PEMF and exercise (PPEMF+EX) and group three will be treated by PEMF alone (PEMF). The exercise training program will include treadmill and aerobic exercises for hip and upper limb will be performed for 50 minutes.PEMF was administered to the whole body for PEMF groups using a 1.8×0.6m mat 30 minutes/day, 3 times/week for 3 months. Dual-energy X-ray absorptiometry (DEXA) will assess Bone mineral density BMD (g/cm2), bone mineral content (BMC), T-Score and Z-Score at the lumbar spine, proximal femur and forearm region, bone markers (25-hydroxy Vit D , Total, undercarboxylated Ostocalcin, Parathyroid Hormone, Total and Ionized calcium and Alkaline Phosphatase (ALP), also will be measured. The assessment will be done at baseline, after treatment (12 weeks) and after 6 months as follow up. The data will be analyzed using repeated measures Analysis of variance (ANOVA) for comparison between pre-treatment and post treatment measurement intervals. One-way ANOVA is used to compare between each treatment interval in treatment groups at pre-test and post treatment measurement intervals. The level of significance is set at 0.05 for all tests.

Official Title
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Long-term Effect of Electromagnetic Field in Treatment of Patients With Osteopenia or Osteoporosis. A Randomized Placebo-controlled Trial.

Conditions
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Osteopenia or Osteoprosis

Intervention / Treatment
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* Other: Pulsed Electromagnetic Field (PEMF)
* Other: Exercise Program
* Other: Placebo PEMF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a T-scores of ≤ ˗1.5, all patients received the same medical treatment for osteoporosis and the same average blood glucose level, sufficient ability to understand the nature and potential risks of the study. Exclusion Criteria: Diabetes mellitus, ischemic heart disease, arrhythmia, uncontrolled thyroid disease, cardiac pacemaker, tuberculosis, neuropsychiatric disorders (dementia, cerebrovascular disease, alcohol abuse, severe depression, panic disorder, bipolar disorder, or psychosis), and malignancy.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>Group one received PEMF and exercise (PEMF+EX) | Other: Pulsed Electromagnetic Field (PEMF)<br>* PEMF was administered to the whole body using a 1.8×0.6m mat<br>Other: Exercise Program<br>* Exercise program to facilitate bone health<br>|
| Placebo Comparator: Group II<br>Group two received placebo PEMF and exercise (PPEMF+EX) | Other: Exercise Program<br>* Exercise program to facilitate bone health<br>Other: Placebo PEMF<br>* Patients received placebo PEMF<br>|
| Active Comparator: Group III<br>Group three will be treated by PEMF alone (PEMF) | Other: Pulsed Electromagnetic Field (PEMF)<br>* PEMF was administered to the whole body using a 1.8×0.6m mat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Bone Mineral Density at 3 months | Bone Mineral Density will assessed by the DEXA in the lumbar spine, proximal femur and forearm region in g/cm2. | Baseline and 3 months, and 6 months post-intervention | 
| Change from baseline Vitamin D levels at 3 months | Vitamin D test is the most accurate way to measure how much vitamin D is in the body. Vitamin D in serum will measured as a standard procedure at the Department of Clinical Chemistry. | Baseline and 3 months, and 6 months post-intervention | 
| Change from baseline Alkaline Phosphatase at 3 months | Alkaline Phosphatase will be estimated colorimetric end point and kinetic using fully automated analyzer Advia Centaur, according to enclosed pamphlet. | Baseline and 3 months, and 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Osteocalcin at 3 months | Ostocalcin is a predictive marker for osteoprosis and bone fracture. Serum Osteocalcin will measured in serum samples using an ELISA Kits. | Baseline and 3 months, and 6 months post-intervention | 
| Change from baseline Parathyroid Hormone at 3 months | Parathyroid hormones (PTH) will measurement chemiluminescence immunoassays [QuiCkIntraOperativeTM intact PTH. The assay will performed on the Immuno- automated analyzer (DPC) at the Department of Clinical Chemistry at Um ALQURA University, Faculty of Applied Medical Science. The Roche intact-PTH test will be assayed on an Elecsys-1010 immunoassay analyzer (Roche Diagnostics) with its Stat-function. | Baseline and 3 months, and 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T-scores of ≤ ˗1.5