Vertebroplasty for the Treatment of Fractures Due to Osteoporosis

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00068822
First received: September 10, 2003
Last updated: September 24, 2012
Last verified: September 2012
  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
Spinal Fractures
Osteoporosis
Device: Percutaneous vertebroplasty
Procedure: Sham vertebroplasty
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigational Vertebroplasty Efficacy and Safety Trial (INVEST)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

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

  • Patient's Rating of Average Pain at 1 Month [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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:
  • Patient Well-being at 1 Month [ Time Frame: Month 1 ] [ Designated as safety issue: No ]

    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.



Enrollment: 131
Study Start Date: April 2003
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068822

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David F. Kallmes, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David F. Kallmes, MD (PI), Mayo Clinic
ClinicalTrials.gov Identifier: NCT00068822     History of Changes
Other Study ID Numbers: 1912-03, R01AR049373, NIAMS-096, UL1RR025014
Study First Received: September 10, 2003
Results First Received: August 7, 2012
Last Updated: September 24, 2012
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
Vertebroplasty
Crushed Vertebrae
Back Pain
Structurally Unstable Vertebrae
polymethylmethacrylate
INVEST
PMMA
RDQ

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Spinal Fractures
Osteoporotic Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries
Polymethyl Methacrylate
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014