Vertebroplasty for the Treatment of Fractures Due to Osteoporosis

Osteoporosis Clinical Trial

Official title:

Investigational Vertebroplasty Efficacy and Safety Trial (INVEST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068822
• Other study ID #: 1912-03
• Secondary ID: R01AR049373NIAMS
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2003
• Last updated: September 24, 2012
• Start date: April 2003
• Est. completion date: September 2009

Study information

• Verified date: September 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporotic Fractures
• Spinal Fractures

Intervention

Device:
• Percutaneous vertebroplasty
Placement of polymethylmethacrylate (PMMA) into vertebral compression fracture

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 E — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month after procedure	No
Primary	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.	1 month	Yes
Secondary	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.	Month 1	No

External Links

•   Mayo Clinic Clinical Trials