The Italian observational study on severe osteoporosis (ISSO): 24-month results on incidence of fractures and adherence to treatment
- Autori: Idolazzi, Luca*; Maugeri, Domenico; Monti, Salvatore; Massarotti, Marco; Osella, Giangiacomo; Barbagallo, Mario; Del Fiacco, Romano; Silvestri, Sandra; Adami, Silvano; Altomonte, Lorenzo; Bardoscia, Alfredo; Bertoldo, Francesco; Bevilacqua, Maurizio; Bianchi, Gerolamo; Brancati, Annamaria; Cagnoni, Carlo; Cantatore, Francesco Paolo; Capone, Antonio; Costanzo, Giuseppe; D'Avola, Giovanni; De Giorgi, Giuseppe; Di Matteo, Luigi; Di Munno, Ombretta; Filipponi, Paolo; Frisina, Nicola; Fusco, Alessandra; Giannini, Sandro; Guiducci, Serena; Iolascon, Giovanni; Isaia, Giancarlo; Lombardi, Gaetano; Malavolta, Nazzarena; Marcocci, Claudio; Migliaccio, Silvia; Migliore, Alberto; Muratore, Maurizio; Nardi, Alfredo; Ortolani, Sergio; Pasquali, Renato; Petto, Helmut; Pietrogrande, Luca; Pola, Enrico; Previti, Baldassarre; Resmini, Giuseppina; Rubinacci, Alessandro; Russo, Enzo; Scillitani, Alfredo; Silveri, Ferdinando; Leali, Paolo Tranquilli; Trotta, Francesco; Ulivieri, Massimo; Verdoia, Cesare; Versace, Francesco; Vinicola, Vincenzo
- Anno di pubblicazione: 2016
- Tipologia: Articolo in rivista (Articolo in rivista)
- Parole Chiave: Fractures; Observational study; Osteoporosis; Osteoporosis therapy; Parathyroid hormone; Spinal fractures; Spine; Teriparatide; Rheumatology; Immunology and Allergy; Immunology
- OA Link: http://hdl.handle.net/10447/297468
Abstract
Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study.