Vertebroplasty for acute painful osteoporotic fractures (VAPOUR): Study protocol for a randomized controlled trial

Abstract

Background: With increasing human longevity there is increasing prevalence of osteoporosis and of osteoporotic vertebral fractures. Most vertebral fractures do not require medical therapy for pain, but a minority are associated with severe pain and disability. Methods: This is a blinded trial of Vertebroplasty for Acute Painful Osteoporotic fractURes - the VAPOUR trial. Patients greater than 60 years in age with new severe onset of back pain and osteoporotic vertebral fractures of less than 6 weeks duration will be enrolled. They will be randomized to receive either vertebroplasty or a placebo procedure. Data regarding pain, disability, and quality of life will be collected over a 6-month period. The enrolled patients and the outcome assessors will remain blinded for the duration of the trial. Discussion: The VAPOUR trial will apply similar methodology to the previous blinded trials but in a patient group with exclusively acute fractures and the most severe pain. Trial registration: ClinicalTrials.gov trial identifier: NCT01482793 registered on 28 November 2011.