title: Oral bisphosphonates do not increase the risk of severe upper gastrointestinal complications: a nested case-control study.
abstract: BACKGROUND
  Data on the effect of oral bisphosphonates (BPs) on risk of upper gastrointestinal complications (UGIC) are conflicting. We conducted a large population-based study from a network of Italian healthcare utilization databases aimed to assess the UGIC risk associated with use of BPs in the setting of secondary prevention of osteoporotic fractures.
  
  
  METHODS
  A nested case-control study was carried out within a cohort of 68,970 patients aged 45 years or older, who have been hospitalized for osteoporotic fracture from 2003 until 2005. Cases were the 804 patients who experienced hospitalization for UGIC until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio (OR) associated with current and past use of BPs (i.e. for drug dispensation within 30 days and over 31 days prior the outcome onset, respectively) after adjusting for several covariates.
  
  
  RESULTS
  Compared with patients who did not use BPs, current and past users had OR (and 95% confidence interval) of 0.86 (0.60 to 1.22) and 1.07 (0.80 to 1.44) respectively. There was no difference in the ORs estimated according with BPs type (alendronate or risedronate) and regimen (daily or weekly), nor with co-therapies and comorbidities.
  
  
  CONCLUSIONS
  Further evidence that BPs dispensed for secondary prevention of osteoporotic fractures are not associated with increased risk of severe gastrointestinal complications is supplied from this study. Further research is required to clarify the role BPs and other drugs of co-medication in inducing UGIC.
authors.forename: Arianna
authors.initials: A
authors.lastname: Ghirardi
authors.forename: Lorenza
authors.initials: L
authors.lastname: Scotti
authors.forename: Gianluca Della
authors.initials: GD
authors.lastname: Vedova
authors.forename: Luca Cavalieri
authors.initials: LC
authors.lastname: D'Oro
authors.forename: Francesco
authors.initials: F
authors.lastname: Lapi
authors.forename: Francesco
authors.initials: F
authors.lastname: Cipriani
authors.forename: Achille P
authors.initials: AP
authors.lastname: Caputi
authors.forename: Alberto
authors.initials: A
authors.lastname: Vaccheri
authors.forename: Dario
authors.initials: D
authors.lastname: Gregori
authors.forename: Rosaria
authors.initials: R
authors.lastname: Gesuita
authors.forename: Annarita
authors.initials: A
authors.lastname: Vestri
authors.forename: Tommaso
authors.initials: T
authors.lastname: Staniscia
authors.forename: Giampiero
authors.initials: G
authors.lastname: Mazzaglia
authors.affiliation: Department of Statistics and Quantitative Methods, Unit of Biostatistics and Epidemiology, University of Milano-Bicocca, Via Bicocca degli Arcimboldi 8, 20126 Milan, Italy. giovanni.corrao@unimib.it.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Corrao
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D016022:Case-Control Studies; D015897:Comorbidity; D004164:Diphosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D058866:Osteoporotic Fractures / Q000517:prevention & control; D012307:Risk Factors; D055502:Secondary Prevention
chemical_list: D050071:Bone Density Conservation Agents; D002121:Calcium Channel Blockers; D004164:Diphosphonates; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors