Upper GI Handling of Branded vs. Generic Alendronate

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00400530

2006_050

Details and patient eligibility

About

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.

Sex: Female

Ages: 55 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind