Effectiveness of denosumab on back pain-related disability and quality of life in patients with vertebral fragility fractures.
Curr Med Res Opin. 2018 Nov 08;:1-18 Authors: Moretti A, de Sire A, Curci C, Toro G, Gimigliano F, Iolascon G
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: We carried out a real practice prospective study, 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. We assessed as primary outcome back pain related disability 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 Analogue Scale, EQ-VAS). All outcome measures were assessed at baseline (T0), after 6 months (T1), and after 12 months (T2) of treatment. We also evaluated Trabecular Bone Score (TBS), lumbar spine (LS) and femoral neck (FN) BMD at T0 and T2. RESULTS: We included 140 post-menopausal women, mean aged 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: Our data demonstrated that denosumab was effective in reducing back pain related disability and in improving HRQoL in post-menopausal women with vertebral fractures. PMID: 30406685 [PubMed - as supplied by publisher]