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Moretti, Antimo; Sire, Alessandro de; Curci, Claudio; Toro, Giuseppe; Gimigliano, Francesca; Iolascon, Giovanni

2018

Background: 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.Objective: To assess the effectiveness of denosumab in reducing back pain related disability and improving HRQoL in osteoporotic post-menopausal women with vertebral fractures.Research design and methods: 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.Results: 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 (p < 0.001), SF-12 PCS (p < 0.001), SF-12 MCS (p < 0.001), EQ-5D-3L index (p = 0.039), and EQ-VAS (p = 0.003). Moreover, there was a significant improvement of both LS BMD (p < 0.001) and FN BMD (p < 0.001). No local or systemic adverse events, including new vertebral fractures, osteonecrosis of the jaw and atypical femur fractures, were reported.Conclusions: The data demonstrated that denosumab was effective in reducing back pain related disability and in improving HRQoL in post-menopausal women with vertebral fractures.

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