78 patients with painful osteoporotic vertebral fractures were randomized to receive a vertebroplasty spinal procedure or placebo approach, with the purpose of comparing clinical outcomes between treatments up to two years. Results indicated no significant between group differences in overall pain (primary outcome) and all other secondary outcomes at the 12-and 24-month follow-up assessments. Risk of developing clinical vertebral fractures was similar between groups, although this study was not adequately powered for this outcome. Routine vertebroplasty is not supported by the findings of this study.