Background. Vertebral body compression fractures (VCFs) impair quality of life (QOL) and increase patient morbidity and mortality. The international, multicentre, randomised, controlled Fracture Reduction Evaluation (FREE) trial was initiated to compare effectiveness and safety of Balloon kyphoplasty (BKP) to non-surgical management (NSM) for the treatment of acute painful VCFs. We describe the primary endpoint of the ongoing 2-year study. Methods. Patients with 1-3 non-traumatic VCFs (< 3 months old) were randomised to either BKP or NSM. The primary endpoint was the change in QOL as measured by the SF-36 Health Survey Physical Component Summary (PCS) at one month, and device/procedure-related safety. Secondary endpoints included SF-36 subscales, the EQ-5D, self-reported back pain and function using the Roland Morris Disability Questionnaire (RMDQ). All patients were given osteoporosis medical therapy. Results. Among the BKP (N=149) and NSM (N=151) cohorts, mean patient age was 73 years and 77% were female. Most patients had VCFs due to primary osteoporosis; 8 patients due to corticosteroid-induced osteoporosis, and 4 had cancer-related fractures. Thirty-nine BKP (26%) and 36 NSM (24%) patients had >1 VCF treated. At one month follow-up, the mean improvement in the PCS was in favour of BKP over NSM (p<0.0001). All physical component SF-36 subscales and the total EQ-5D score were significantly improved for BKP compared to NSM. Mean improvements in back pain at 7 days and 1 month were significantly greater for BKP compared to NSM (p<0.0001 at both time points). The improvement in RMDQ for BKP over NSM was also significant (p<0.0001). There was one soft tissue haematoma and urinary tract infection, with no bone cement-related serious adverse events. Conclusions. Compared to non-surgical management, balloon kyphoplasty demonstrated superior short-term pain, function and quality of life outcomes with no difference in serious adverse events for the treatment of acute, painful vertebral compression fractures. (Clinical trials.gov number, NCT00211211)