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Vertebroplasty for the Treatment of Fractures Due to Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00068822
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : September 27, 2012
Last Update Posted : September 27, 2012
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Research Resources (NCRR)
Information provided by:
Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Spinal Fractures Osteoporosis Device: Percutaneous vertebroplasty Procedure: Sham vertebroplasty Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigational Vertebroplasty Efficacy and Safety Trial (INVEST)
Study Start Date : April 2003
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vertebroplasty
Participants will receive percutaneous vertebroplasty
Device: Percutaneous vertebroplasty
Placement of polymethylmethacrylate (PMMA) into vertebral compression fracture

Placebo Comparator: Control Group
Participants will receive sham vertebroplasty without PMMA
Procedure: Sham vertebroplasty
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.

Primary Outcome Measures :
  1. Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month [ Time Frame: 1 month after procedure ]
    Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability.

  2. Patient's Rating of Average Pain at 1 Month [ Time Frame: 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.

Secondary Outcome Measures :
  1. Patient Well-being at 1 Month [ Time Frame: Month 1 ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00068822

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Research Resources (NCRR)
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Principal Investigator: David F. Kallmes, MD Mayo Clinic
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David F. Kallmes, MD (PI), Mayo Clinic Identifier: NCT00068822    
Other Study ID Numbers: 1912-03
R01AR049373 ( U.S. NIH Grant/Contract )
UL1RR025014 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2003    Key Record Dates
Results First Posted: September 27, 2012
Last Update Posted: September 27, 2012
Last Verified: September 2012
Keywords provided by Mayo Clinic:
Crushed Vertebrae
Back Pain
Structurally Unstable Vertebrae
Additional relevant MeSH terms:
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Fractures, Bone
Spinal Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Injuries
Back Injuries