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Vertebroplasty for the Treatment of Fractures Due to Osteoporosis

Primary Purpose

Spinal Fractures, Osteoporosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Percutaneous vertebroplasty
Sham vertebroplasty
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Fractures focused on measuring Vertebroplasty, Crushed Vertebrae, Back Pain, Structurally Unstable Vertebrae, polymethylmethacrylate, INVEST, PMMA, RDQ

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vertebroplasty

Control Group

Arm Description

Participants will receive percutaneous vertebroplasty

Participants will receive sham vertebroplasty without PMMA

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 10, 2003
Last Updated
September 24, 2012
Sponsor
Mayo Clinic
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00068822
Brief Title
Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
Official Title
Investigational Vertebroplasty Efficacy and Safety Trial (INVEST)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Fractures, Osteoporosis
Keywords
Vertebroplasty, Crushed Vertebrae, Back Pain, Structurally Unstable Vertebrae, polymethylmethacrylate, INVEST, PMMA, RDQ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vertebroplasty
Arm Type
Experimental
Arm Description
Participants will receive percutaneous vertebroplasty
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Participants will receive sham vertebroplasty without PMMA
Intervention Type
Device
Intervention Name(s)
Percutaneous vertebroplasty
Intervention Description
Placement of polymethylmethacrylate (PMMA) into vertebral compression fracture
Intervention Type
Procedure
Intervention Name(s)
Sham vertebroplasty
Intervention Description
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 Measure Information:
Title
Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month
Description
Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability.
Time Frame
1 month after procedure
Title
Patient's Rating of Average Pain at 1 Month
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Patient Well-being at 1 Month
Description
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.
Time Frame
Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David F. Kallmes, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14519867
Citation
Kallmes DF, Jensen ME. Percutaneous vertebroplasty. Radiology. 2003 Oct;229(1):27-36. doi: 10.1148/radiol.2291020222.
Results Reference
background
PubMed Identifier
19657122
Citation
Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, Edwards R, Gray LA, Stout L, Owen S, Hollingworth W, Ghdoke B, Annesley-Williams DJ, Ralston SH, Jarvik JG. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009 Aug 6;361(6):569-79. doi: 10.1056/NEJMoa0900563. Erratum In: N Engl J Med. 2012 Mar 8;366(10):970.
Results Reference
result
PubMed Identifier
23696683
Citation
Comstock BA, Sitlani CM, Jarvik JG, Heagerty PJ, Turner JA, Kallmes DF. Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year. Radiology. 2013 Oct;269(1):224-31. doi: 10.1148/radiol.13120821. Epub 2013 May 21.
Results Reference
derived
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

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Vertebroplasty for the Treatment of Fractures Due to Osteoporosis

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