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To evaluate the association between oral BP and ONJ, GI-events, or fractures; to estimate the incidence of ONJ, GI-events, or fractures and the role of predisposing risk factors (i.e. BP adherence/persistence, molecules, dosage, demographic/clinical variables); to assess clinical and demographic predictors of oral BP use or adherence/persistence.



Retrospective cohort study with nested case-control analysis

PARTICIPANTS: patients from 5 Italian Regions and 10 Local Health Authorities, aged 55 years and older, discharged from hospital with a primary diagnosis of fracture at osteoporotic sites during an 18-months period. Patients will be considered on BP treatment once upon receipt of a first prescription with alendonic or risedronic acid after hospital discharge.

OUTCOMES: Incidence rate ratio of ONJ, GI-events, or fractures in BP treated vs. untreated patients will be calculated. Survival models (and propensity analyses) will be used to estimate hazard ratios for the association between use or adherence/persistence with BP therapy, and occurrence of the investigated events. We will conduct a nested case-control analysis with ONJ or GI-events patients, matched with up to twenty controls on age, gender, geographic area, and date of cohort entry. Logistic regressions will be used to estimate the odds ratios for the association between BP use and the risk of ONJ or GI-events. BP exposure will be defined according to the latest date of pharmacy claims supply.


Results will provide:

  1. reliable incidence rates of ONJ in osteoporotic patients, treated/untreated with oral BP;
  2. the number of patients who need to be treated to prevent one hospitalization for osteoporotic fracture;
  3. the number of patients who need to be treated to cause ONJ or GI-event.

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