Objective: Vertebral fragility fractures increase morbidity, mortality and health care costs related to osteoporosis. Persistent pain and disability are common in patients with vertebral fractures. Anti- osteoporotic drugs reduce significantly the risk of new fragility fractures and might reduce pain and functional impairment due to vertebral osteoporotic fractures. DIRP (denosumab In Real Practice) is a study that aims to evaluate the effectiveness of denosumab in pain control, in reducing functional limitation and improving quality of life in a cohort of postmenopausal women with at least one osteoporotic vertebral fracture. Materials and Methods: This study includes a cohort of osteoporotic women with indication for denosumab. According to the Italian reimbursement criteria for osteoporosis (National Health Service 79), denosumab is indicated for postmenopausal women with at least one vertebral fragility fracture, detected with radiographic imaging or Lateral Vertebral Assessment (LVA). In this population, pain and functional limitation are assessed with the Spine Pain Index (SPI), and health-related quality of life with the 12-Item Short-Form Health Survey (SF-12). Results: A total of 217 women, mean aged 74.5 years were evaluated. Of these, 35 (16.1 %) had a single vertebral fracture, 51 (39.6 %) 2 fractures and 131 (44.3%) more than 2 vertebral fractures. 132 women (60.8 %) had a BMD value of T-score≤−2.5 SD. The severity of back pain was mild or negligible in 34 patients (15.7 %), moderate in 112 (51.6 %), while 71 women (32.7 %) had a severe pain. Overall, 183 patients (84.3 %) needed a treatment for pain, according to WHO. The quality of life perceived by patients treated with denosumab was significantly reduced in both physical (SF-12 PCS) and mental (SF-12 MCS) components. Conclusion: In Italy, Denosumab can be prescribed only in patients with advanced osteoporosis characterized by multiple fragility fractures, moderate to severe persistent back pain, disability, and a poor quality of life. This is in contrast with what it should be expected for a front-line drug for osteoporosis.

P507 BASELINE CHARACTERISTICS OF THE POPULATION ENROLLED IN DIRP (DENOSUMAB IN REAL PRACTICE) STUDY

G Iolascon;Moretti A;F Gimigliano
2015

Abstract

Objective: Vertebral fragility fractures increase morbidity, mortality and health care costs related to osteoporosis. Persistent pain and disability are common in patients with vertebral fractures. Anti- osteoporotic drugs reduce significantly the risk of new fragility fractures and might reduce pain and functional impairment due to vertebral osteoporotic fractures. DIRP (denosumab In Real Practice) is a study that aims to evaluate the effectiveness of denosumab in pain control, in reducing functional limitation and improving quality of life in a cohort of postmenopausal women with at least one osteoporotic vertebral fracture. Materials and Methods: This study includes a cohort of osteoporotic women with indication for denosumab. According to the Italian reimbursement criteria for osteoporosis (National Health Service 79), denosumab is indicated for postmenopausal women with at least one vertebral fragility fracture, detected with radiographic imaging or Lateral Vertebral Assessment (LVA). In this population, pain and functional limitation are assessed with the Spine Pain Index (SPI), and health-related quality of life with the 12-Item Short-Form Health Survey (SF-12). Results: A total of 217 women, mean aged 74.5 years were evaluated. Of these, 35 (16.1 %) had a single vertebral fracture, 51 (39.6 %) 2 fractures and 131 (44.3%) more than 2 vertebral fractures. 132 women (60.8 %) had a BMD value of T-score≤−2.5 SD. The severity of back pain was mild or negligible in 34 patients (15.7 %), moderate in 112 (51.6 %), while 71 women (32.7 %) had a severe pain. Overall, 183 patients (84.3 %) needed a treatment for pain, according to WHO. The quality of life perceived by patients treated with denosumab was significantly reduced in both physical (SF-12 PCS) and mental (SF-12 MCS) components. Conclusion: In Italy, Denosumab can be prescribed only in patients with advanced osteoporosis characterized by multiple fragility fractures, moderate to severe persistent back pain, disability, and a poor quality of life. This is in contrast with what it should be expected for a front-line drug for osteoporosis.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11591/419616
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