Clark William, Bird Paul, Diamond Terrence, Gonski Peter
Department of Interventional Radiology, St George Private Hospital, Kogarah, NSW, Australia.
University of NSW, Sydney, NSW, Australia.
Trials. 2015 Apr 12;16:159. doi: 10.1186/s13063-015-0671-8.
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.
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.
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.
ClinicalTrials.gov trial identifier: NCT01482793 registered on 28 November 2011.
随着人类寿命的延长，骨质疏松症及骨质疏松性椎体骨折的患病率不断上升。大多数椎体骨折无需药物治疗疼痛，但少数会伴有严重疼痛和残疾。椎体成形术已越来越多地用于治疗疼痛性急性骨质疏松性骨折。椎体成形术的最佳现有证据来自两项安慰剂对照试验，这两项试验表明椎体成形术相对于安慰剂并无显著临床益处。这两项试验并非急性骨折试验，两项试验中的大多数骨折都远远超过了6周的急性时间范围。有一项开放性随机对照试验比较了椎体成形术与急性骨折保守治疗的效果，表明椎体成形术对急性椎体骨折具有临床疗效。
这是一项针对急性疼痛性骨质疏松性骨折椎体成形术的双盲试验——VAPOUR试验。将纳入年龄大于60岁、新发严重背痛且骨质疏松性椎体骨折病程小于6周的患者。他们将被随机分配接受椎体成形术或安慰剂治疗。将在6个月的时间内收集有关疼痛、残疾和生活质量的数据。在试验期间，已纳入的患者和结果评估者将保持盲态。
VAPOUR试验将采用与之前双盲试验相似的方法，但针对的是仅患有急性骨折且疼痛最严重的患者群体。
ClinicalTrials.gov试验标识符：NCT01482793，于2011年11月28日注册。
