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

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. Vertebroplasty has been used increasingly for painful acute osteoporotic fractures. The best available evidence for vertebroplasty is provided by two placebo controlled trials which showed no significant clinical benefit of vertebroplasty over placebo. These were not acute fracture trials with the majority of fractures in both trials being well beyond the acute time frame of 6 weeks. There is evidence from an open label randomized controlled trial of vertebroplasty versus conservative therapy in acute fractures suggesting clinical efficacy in acute vertebral fractures. 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.