Clinical trial NCT00068822: Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
Official title: Investigational Vertebroplasty Efficacy and Safety Trial (INVEST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Fractures
Osteoporosis
Keywords: Vertebroplasty
Crushed Vertebrae
Back Pain
Structurally Unstable Vertebrae
polymethylmethacrylate
INVEST
PMMA
RDQ
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Center for Research Resources (NCRR)
First posted: 2003-09-11
Enrollment: 131
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month
timeFrame: 1 month after procedure
measure: Patient's Rating of Average Pain at 1 Month
timeFrame: 1 month
Secondary outcomes:
measure: Patient Well-being at 1 Month
timeFrame: Month 1
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David F. Kallmes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kallmes DF, Jensen ME. Percutaneous vertebroplasty. Radiology. 2003 Oct;229(1):27-36. doi: 10.1148/radiol.2291020222.
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.
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.