Effectiveness of denosumab on back pain-related disability and quality-of-life in patients with vertebral fragility fractures.

Denosumab is a fully human IgG2 monoclonal antibody that, neutralizing the receptor activator of nuclear factor kappa-Β ligand (RANKL), inhibits the osteoclast-mediated bone resorption. It is yet to be defined if denosumab can reduce osteoporosis-related disability and improve health-related quality-of-life (HRQoL) in patients with fragility fractures. To assess the effectiveness of denosumab in reducing back pain related disability and improving HRQoL in osteoporotic post-menopausal women with vertebral fractures. A real practice prospective study was carried out, enrolling women over 50 years with a post-menopausal osteoporosis that experienced at least one vertebral fracture receiving subcutaneous denosumab (60 mg, every 6 months), calcium carbonate (500-1000 mg/day) and cholecalciferol (800 IU/day) for 1 year. Back pain related disability was assessed as the primary outcome using the Spine Pain Index (SPI); secondary outcomes were: SF-12 (Physical Health Composite Score, PCS, and Mental Health Composite Score, MCS), and EuroQol-5D (EuroQol-5D-3L index and EuroQol-Visual Analog Scale, EQ-VAS). All outcome measures were assessed at baseline (T0), after 6 months (T1), and after 12 months (T2) of treatment. Trabecular Bone Score (TBS), lumbar spine (LS) and femoral neck (FN) BMD at T0 and T2 were also evaluated. This study included 140 post-menopausal women, mean age = 70.60 (SD = 8.81) years. There were statistically significant differences after 12 months (T2-T0) in all outcomes assessed: SPI ( < 0.001), SF-12 PCS ( < 0.001), SF-12 MCS ( < 0.001), EQ-5D-3L index ( = 0.039), and EQ-VAS ( = 0.003). Moreover, there was a significant improvement of both LS BMD ( < 0.001) and FN BMD ( < 0.001). No local or systemic adverse events, including new vertebral fractures, osteonecrosis of the jaw and atypical femur fractures, were reported. The data demonstrated that denosumab was effective in reducing back pain related disability and in improving HRQoL in post-menopausal women with vertebral fractures.