Vertebroplasty for the Treatment of Fractures Due to Osteoporosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigational Vertebroplasty Efficacy and Safety Trial (INVEST)

Conditions
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Spinal Fractures, Osteoporosis

Intervention / Treatment
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* Device: Percutaneous vertebroplasty
* Procedure: Sham vertebroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed osteoporosis or osteopenia by a referring physician and/or medical history and physical exam OR osteopenia on plain film Vertebral compression fracture in vertebrae T4 through L5, of less than 1 year old Pain not responsive to standard medical therapy Current rating for pain intensity of at least 3 on a scale of 0 to 10 Exclusion Criteria: Evidence or suspicion of malignant tumor or spinal canal compromise Concomitant hip fracture Local or systemic infection Uncorrectable bleeding diatheses Surgery within the previous 60 days Lack of access to telephone Inability to communicate in English Dementia Pregnancy Abnormal renal function or anticipated venography Conscious sedation is contraindicated for subject

Ages Eligible for Study
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Minimum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vertebroplasty<br>Participants will receive percutaneous vertebroplasty | Device: Percutaneous vertebroplasty<br>* Placement of polymethylmethacrylate (PMMA) into vertebral compression fracture<br>|
| Placebo Comparator: Control Group<br>Participants will receive sham vertebroplasty without PMMA | Procedure: Sham vertebroplasty<br>* Participants, following local anesthesia with lidocaine and bupivacaine, were given verbal and physical cues such as pressure on the back, but the needle was not placed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month | Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability. | 1 month after procedure | 
| Patient's Rating of Average Pain at 1 Month | Patient's rating of average pain intensity during the preceding 24 hours at 1 month. The rating scale was from 0 to 10, with higher scores indicating more severe pain. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Well-being at 1 Month | Patient well-being was quantified by these tools: Health status outcome using Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable). Pain Frequency Index, Pain Bothersome Index (scores range from 0-4, higher scores indicating more severe pain). European Quality of Life (QOL) 5 Dimensions (EQ-5D), scale range -0.1 to 1.0; higher scores indicating a better QOL. Study of Osteoporotic Fractures-Activities of Daily Living (SOF ADL6) range from 0 to 18; higher scores = more back-related disability. | Month 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertebroplasty, Crushed Vertebrae, Back Pain, Structurally Unstable Vertebrae, polymethylmethacrylate, INVEST, PMMA, RDQ