Upper GI Handling of Branded vs. Generic Alendronate

Merck Sharp & Dohme LLC25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoporosis

Interventions

MK0217, alendronate sodium / Duration of Treatment: 1 MonthDRUG

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

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Gamma camera imaging of tablet dissolution in oesophagus

Secondary Outcomes

Gamma camera dissolution of tablets in stomach

Data from ClinicalTrials.gov

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