Vertebroplasty for the Treatment of Fractures Due to Osteoporosis - Full Text View

Sponsor:	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
Spinal Fractures Osteoporosis	Device: Percutaneous vertebroplasty Procedure: Placebo	Phase III

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)

Resource links provided by NLM:

MedlinePlus related topics: Fractures Osteoporosis

U.S. FDA Resources

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Back-specific functional status using Roland Scale at the 1-month time frame [ Time Frame: Month 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Health status outcome using SF-36 [ Time Frame: Month 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	294
Study Start Date:	April 2003
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive percutaneous vertebroplasty	Device: Percutaneous vertebroplasty Placement of PMMA into vertebral compression fracture
2: Placebo Comparator Participants will receive partial vertebroplasty without PMMA	Procedure: Placebo Placebo surgery

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
Vertebral compression fracture in vertebrae T4 through L5
Pain not responsive to medical therapy

Exclusion Criteria:

Malignant tumor or spinal canal compromise
Local or systemic infection
Pregnancy
Hip fracture

Contacts and Locations

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

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Principal Investigator:

David F. Kallmes, MD

Mayo Clinic

More Information

Publications:

Kallmes DF, Jensen ME. Percutaneous vertebroplasty. Radiology. 2003 Oct;229(1):27-36. Review.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Mayo Clinic ( David F. Kallmes, MD (PI) )
Study ID Numbers:	R01 AR049373, NIAMS-096
Study First Received:	September 10, 2003
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00068822 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Vertebroplasty
Crushed Vertebrae
Back Pain
Structurally Unstable Vertebrae

Additional relevant MeSH terms:

Musculoskeletal Diseases
Spinal Injuries
Fractures, Bone
Back Injuries
Wounds and Injuries

Spinal Fractures
Disorders of Environmental Origin
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on November 09, 2009