A Comparative Study of the Safety of Generic Alendronate Tablet Formulations Using Receipt Data

A Comparative Study of the Safety of Generic Alendronate Tablet Formulations Using Receipt Data - A Comparative Study of the Safety of Generic Alendronate Tablet Formulations Using Receipt Data

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045403

Enrollment

34000

Registered

2021-09-07

Start date

2021-07-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper gastrointestinal events

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with at least one oral claim for alendronic acid in the database

Exclusion criteria

Exclusion criteria: Patients who have information on the dispensing of oral bisphosphonates other than alendronate during the baseline period Patients who have information on the preparation of bisphosphonates other than alendronate (including injectables) during the follow-up period

Design outcomes

Primary

Measure	Time frame
Percentage of patients diagnosed with upper gastrointestinal disease within 90 days of first dispensing alendronate tablets	—

Secondary

Measure	Time frame
Percentage of patients diagnosed with upper gastrointestinal disease within 90 days of first dispensing alendronate tablets Percentage of patients whose prescriptions were discontinued within 90 days of an upper gastrointestinal event	—

Countries

Japan

Contacts

Public ContactShih-Wei Chiu

Tohoku University Graduate School of Medicine Division of Biostatistics

chiu.shih.wei.a7@tohoku.ac.jp022-717-7659

Outcome results