Non-interventional study with Binosto 70 mg effervescent tablets once weekly investigating gastro-intestinal events and medication errors (Gastro-PASS)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Binosto

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1200

Study design details

• Main study objective:
  The main objective of the study is to investigate known safety concerns (oesophageal toxicity, gastritis, gastric ulcers, duodenitis) and medication errors of the class of oral bisphosphonates, which may be relevant for the new product, alendronic acid 70 mg effervescent tablets (Binosto), which represents a new pharmaceutical formulation of alendronate.
• Outcomes:
  To calculate the cumulative incidence of GI ADRs (individual reactions and composite events*) of Binosto. Co-primary objective: To calculate the percentage of patients with medication errors of Binosto. - To evaluate persistence, discontinuation and reason, and compliance with SmPC.- To compare the frequency of upper GI AEs collected in the prospective cohort with historical upper GI AEs in a cohort of patients on Alendronate 70mg.- To calculate the incidence rate of Binosto individual gastric AEs.
• Data analysis plan:
  Analyses will be mainly descriptive for the overall study population and subgroups. Comparisons will be made at baseline between with Binosto and the non-concurrent cohort. For the longitudinal phase, the cumulative incidence (proportion) of the primary and secondary endpoints will be calculated with 95% confidence intervals. Univariate study of differences between with Binosto and the non-concurrent cohort will be made in the frequency and incidence of upper gastrointestinal adverse events, using chi-square tests and relative incidence rates with 95% confidence intervals. The proportion (and 95% confidence intervals) of subjects with medication errors will be calculated. Persistence and discontinuation will be analysed using Kaplan-Meier curves. The incidence rates and their 95% confidence interval for solicited individual gastric AEs, at each of the three follow up visits and, globally, at the end of the prospective study, will be calculated.