title: The Italian Observational Study on Severe Osteoporosis (ISSO): 24-month results on incidence of fractures and adherence to treatment.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Lilly Rheumatology Unit, Department of Medicine, University of Verona, Italy. luca.idolazzi@univr.it.
authors.forename: Luca
authors.initials: L
authors.lastname: Idolazzi
authors.affiliation: Geriatric Unit, University of Catania, Cannizzaro Hospital, Catania, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Maugeri
authors.affiliation: Department of Endocrinology, Sant'Andrea Hospital, Sapienza University of Rome, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Monti
authors.affiliation: Division of Rheumatology and Clinical Immunology, Humanitas Research Hospital, Rozzano, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Massarotti
authors.affiliation: Medicina Interna, Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, Italy.
authors.forename: Giangiacomo
authors.initials: G
authors.lastname: Osella
authors.affiliation: Geriatric Unit, Department of Internal Medicine and Geriatrics (DIBIMIS), University of Palermo, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Barbagallo
authors.affiliation: Medical Department Lilly Italia, Sesto Fiorentino, Italy.
authors.forename: Romano
authors.initials: R
authors.lastname: Del Fiacco
authors.affiliation: Medical Department Lilly Italia, Sesto Fiorentino, Italy.
authors.forename: Sandra
authors.initials: S
authors.lastname: Silvestri
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy*; D058866:Osteoporotic Fractures / Q000453:epidemiology*; D011446:Prospective Studies; D019379:Teriparatide / Q000627:therapeutic use
chemical_list: D019379:Teriparatide