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Vertebroplasty for the Treatment of Fractures Due to Osteoporosis Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Vertebroplasty for the Treatment of Fractures Due to Osteoporosis conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Vertebroplasty for the Treatment of Fractures Due to Osteoporosis Clinical research trials and Vertebroplasty for the Treatment of Fractures Due to Osteoporosis healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Vertebroplasty for the Treatment of Fractures Due to Osteoporosis. Vertebroplasty for the Treatment of Fractures Due to Osteoporosis Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Vertebroplasty for the Treatment of Fractures Due to Osteoporosis clinical trial. Participants typically obtain the most effective healthcare available for their Vertebroplasty for the Treatment of Fractures Due to Osteoporosis condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vertebroplasty for the Treatment of Fractures Due to Osteoporosis  Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
For Condition: Spinal Fractures,Osteoporosis
Status: Not yet recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of fractures due to osteoporosis.
Details: Spontaneous, atraumatic compression fractures due to osteoporosis occur in more than 700,000 patients per year. Pain associated with these fractures may be excruciating, but before the advent of percutaneous vertebroplasty, treatment options were limited. Analgesic medications, bed rest, and bracing have been the mainstays of treatment, but each of these therapies has substantial limitations. Because of the dearth of viable treatment options for osteoporotic vertebral compression fractures, the practice of percutaneous vertebroplasty, which involves injection of polymethylmethacrylate (medical cement) into the fractured vertebra, has disseminated rapidly. However, evidence for the efficacy of percutaneous vertebroplasty is currently limited to uncontrolled, nonblinded, small case studies. Even though high rates of success are reported, with up to 90% of patients achieving substantial pain relief, these case studies have not accounted for numerous important potential biases, including the natural tendency for compression fractures to heal spontaneously, regression toward the mean (wherein patients seek medical attention when pain is maximum), and the placebo effect. This study will examine the clinical efficacy of percutaneous vertebroplasty for treatment of painful osteoporotic vertebral compression fractures. Participants in this study will be randomly assigned to receive either percutaneous vertebroplasty or a sham procedure (placebo control group). Participants may have up to 2 spinal levels treated. Participants will be enrolled in the study for 2 years and will have study visits at entry and Months 1, 12, and 24. There will also be phone visits at Days 1, 2, 3, and 14 and Months 3 and 6. After Month 1, crossover from the placebo group to the vertebroplasty group will be allowed.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 50 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Confirmed osteoporosis or osteopenia - Vertebral compression fracture in vertebrae T4 through L5 - Pain not responsive to medical therapy Exclusion Criteria - Malignant tumor or spinal canal compromise - Local or systemic infection - Pregnancy - Prior vertebroplasty or kyphoplasty - Hip fracture
Total Enrollment: 294
Location and Contact Information:
Overall Study Official:
DavidKallmes, Principal Investigator, Mayo Clinic
Mayo Clinic
Rochester, Minnesota, 55905
United States
Leigh Gray 507-255-4377
Additional Information:
Study ID Numbers: NIAMS-096; 1R01AR49373
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068822
Other Osteoporosis Studies:
1. Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
Related Studies:
Other Osteoporosis Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
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