The Efficacy and Safety of Vertebral Augmentation: A Second ASBMR Task Force Report

Abstract

Vertebral augmentation is among the current standards of care to reduce pain in patients with vertebral fractures (VF), yet a lack of consensus regarding efficacy and safety of percutaneous vertebroplasty and kyphoplasty raises questions on what basis clinicians should choose one therapy over another. Given the lack of consensus in the field, the American Society for Bone and Mineral Research (ASBMR) leadership charged this Task Force to address key questions on the efficacy and safety of vertebral augmentation and other nonpharmacological approaches for the treatment of pain after VF. This report details the findings and recommendations of this Task Force. For patients with acutely painful VF, percutaneous vertebroplasty provides no demonstrable clinically significant benefit over placebo. Results did not differ according to duration of pain. There is also insufficient evidence to support kyphoplasty over nonsurgical management, percutaneous vertebroplasty, vertebral body stenting, or KIVA®. There is limited evidence to determine the risk of incident VF or serious adverse effects (AE) related to either percutaneous vertebroplasty or kyphoplasty. No recommendation can be made about harms, but they cannot be excluded. For patients with painful VF, it is unclear whether spinal bracing improves physical function, disability, or quality of life. Exercise may improve mobility and may reduce pain and fear of falling but does not reduce falls or fractures in individuals with VF. General and intervention-specific research recommendations stress the need to reduce study bias and address methodological flaws in study design and data collection. This includes the need for larger sample sizes, inclusion of a placebo control, more data on serious AE, and more research on nonpharmacologic interventions. Routine use of vertebral augmentation is not supported by current evidence. When it is offered, patients should be fully informed about the evidence. Anti-osteoporotic medications reduce the risk of subsequent vertebral fractures by 40-70%.

Response Letter to the Editor—Diamond et al, JBMR

“…The ASBMR Task Force on vertebral augmentation stands by our recommendations that cast doubt on the clinical importance of vertebral augmentation procedures, including vertebroplasty, for the treatment of painful osteoporotic vertebral fractures. (1) We also strongly refute bias in our report. The ASBMR Task Force commenced late in 2013, 2 years before the published protocol for the VAPOUR trial, (2) and comprised experts from previously published blinded vertebral augmentation trials, biomechanics, epidemiology, physical therapy and rehabilitation, exercise, endocrinology, rheumatology, and internal medicine.…”

“…No member had any conflicts of interest. The two ASBMR Task Force reports (1,3) both underwent the normal peer review process by JBMR but were not sent out for external consultation before review, as is normal practice for ASBMR Task Force reports.…”

Percutaneous Vertebroplasty for Acute Painful Osteoporotic Vertebral Fractures—Benefits Shown in VAPOUR Trial Masked When Pooled With Other Clinical Trials

“…We read with interest the ASBMR Task Force report (1) on the efficacy and safety of vertebral augmentation and would like to comment on the Task Force's recommendations relating to the role of percutaneous vertebroplasty for acute osteoporotic vertebral fractures.…”

Response to: Some Questions About the Article “The Efficacy and Safety of Vertebral Augmentation: A Second ASBMR Task Force Report”

“…We thank Ning and colleagues for their question on the relationship of pain duration to the effects of vertebroplasty, in relationship to our article. (1) In response, we refer the authors to the updated Cochrane review, (2) an individual patient data metaanalysis including two placebo-controlled trials, (3) and our response to a previous letter, (4) which provides comprehensive answers to their queries. The Cochrane review includes a detailed description and potential risk of bias of each of the trials included in the evidence synthesis that formed the basis of our conclusions about the value of vertebroplasty for treatment of painful osteoporotic vertebral fractures.…”