Background: There are minimal data describing outcomes after acute clinical osteoporotic vertebral compression fractures (OVCF).
Aim: We report on pain scores, quality of life measures and complication and specified osteofragility risk factors in the placebo-treated individuals in the VAPOUR study.
Methods: VAPOUR is a multi-centre randomised, blinded, parallel group, placebo-controlled trial of vertebroplasty for painful OVCF performed within 6-weeks post fracture. The entry criteria were patients’ age > 60, back pain < 6 weeks duration, numeric rated scale (NRS) pain ≥ 7/10, and Magnetic Resonance Imaging (MRI) or single-photon emission computed tomography confirming one or two recent fractures. Primary outcome measure was numeric rated scale (NRS) pain, on a scale of 0-10 and the secondary outcome measure was Roland-Morris Disability Questionnaire (RMQ).
Results: Data were available on 59 individuals, mean age of 81years, 68% were female and 86% were receiving anti-osteoporotic therapies. 42% of individuals were treated as outpatient and 58% were hospitalised. 46% had pre-existing OVCF. 66% had Genant grade 3 deformities in the newly diagnosed vertebral fracture. The mean NRS pain (8.6) and RMQ scores (19.8) was indicative of severe pain and loss of function on presentation. By 6 months, three individuals (5%) withdrew, three (5%) had died, two (4%) had developed spinal cord compression and two (5%) had sustained new OVCF’s. Mean baseline fracture compression of 46% of height loss had increased to 63%. Despite overall improvements, 27 (53%) had ongoing problematic back pain (numeric rating scale ≥4) and 32 (63%) had significant disability (Roland Morris Questionnaire ≥10) at 6-months. 44 (75%) were considered high risk for recurrent OVCF.
Conclusion: These data confirm that elderly individuals with acute severely painful OVCF treated with usual care, demonstrate adverse outcomes even at 6 months after fracture. Further research should focus on optimal treatments for this high-risk cohort.