Upper GI Handling of Branded vs. Generic Alendronate

A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets

NCT00400530•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side effect profile.

Eligibility

Age

55 - 75 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Post-menopausal females aged greater 55 years
•Prescribed alendronate 70 mg tablets for a therapeutic indication throughout the previous 3 months and expected to continue on this treatment for the duration of the study
•Willing to abstain from alcohol for 24 hours before each dose and until the end of each study day
•Willing to abstain from smoking for 24 hours before each dose and until the end of each study day

Exclusion Criteria

•History of drug hypersensitivity
•Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility

Key Dates

Start Date

December 1, 2005

Last Updated

November 17, 2006

Enrollment

Estimated participants

Conditions

Osteoporosis

Interventions

MK0217, alendronate sodium / Duration of Treatment: 1 Month

DRUG

Comparator: Alendronate-Teva / Duration of Treatment: 1 Month

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2006Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Upper GI Handling of Branded vs. Generic Alendronate

Inclusion Criteria

Exclusion Criteria

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