Vertebroplasty for the Treatment of Fractures Due to Osteoporosis

NCT00068822 | Completed Phase 3 Results DMC

• 4 other identifiers: 1912-03R01AR049373NIAMS-096UL1RR025014
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Fractures; Osteoporosis

Keywords

Vertebroplasty; Crushed Vertebrae; Back Pain; Structurally Unstable Vertebrae; polymethylmethacrylate; INVEST; PMMA; RDQ

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Patient Well-being at 1 Month

  Month 1

Study Arms (2)

Vertebroplasty

EXPERIMENTAL

Participants will receive percutaneous vertebroplasty

Device: Percutaneous vertebroplasty

Control Group

PLACEBO COMPARATOR

Participants will receive sham vertebroplasty without PMMA

Procedure: Sham vertebroplasty

Interventions

Percutaneous vertebroplasty DEVICE

Placement of polymethylmethacrylate (PMMA) into vertebral compression fracture

Vertebroplasty

Sham vertebroplasty PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• Kallmes DF, Jensen ME. Percutaneous vertebroplasty. Radiology. 2003 Oct;229(1):27-36. doi: 10.1148/radiol.2291020222.

  PMID: 14519867 BACKGROUND

• 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.

  PMID: 19657122 RESULT

• 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.

  PMID: 23696683 DERIVED

MeSH Terms

Conditions

Spinal Fractures; Osteoporosis; Back Pain

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The possible role of the placebo effect on outcomes remains unclear. Crossover at 1 month was allowed, which complicated the interpretation of between-group outcome differences. Other medical treatments received were not compared to study groups.

Results Point of Contact

• Title: David F. Kallmes, M.D.
• Organization: Mayo Clinic

kallmes.david@mayo.edu

507-266-3350

Study Officials

• David F. Kallmes, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: April 1, 2003
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 27, 2012
• Results First Posted: September 27, 2012

Record last verified: 2012-09

Locations

US (1)