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| Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT00068822 |
Purpose
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.
| Condition | Intervention | Phase |
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Spinal Fractures Osteoporosis |
Procedure: Percutaneous vertebroplasty Procedure: Placebo |
Phase III |
| MedlinePlus related topics: | Fractures Osteoporosis |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Investigational Vertebroplasty Efficacy and Safety Trial (INVEST) |
| Estimated Enrollment: | 294 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Participants will receive percutaneous vertebroplasty
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Procedure: Percutaneous vertebroplasty
Placement of PMMA into vertebral compression fracture
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2: Placebo Comparator
Participants will receive partial vertebroplasty without PMMA
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Procedure: Placebo
Placebo surgery
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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 1 year and will have study visits at entry and Months 1 and 12. 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
| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Mayo Clinic ( David F. Kallmes, MD (PI) ) |
| Study ID Numbers: | R01 AR49373, NIAMS-096 |
| First Received: | September 10, 2003 |
| Last Updated: | November 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068822 |
| Health Authority: | United States: Federal Government |
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