Upper GI Handling of Branded vs. Generic Alendronate

Condition(s) targeted: Osteoporosis

Intervention: MK0217, alendronate sodium / Duration of Treatment: 1 Month (Drug); Comparator: Alendronate-Teva / Duration of Treatment: 1 Month (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome: Gamma camera imaging of tablet dissolution in oesophagus

Secondary outcome: Gamma camera dissolution of tablets in stomach

Minimum age: 55 Years. Maximum age: 75 Years. Gender(s): Female.

Criteria:

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

Starting date: December 2005
Last updated: November 16, 2006