Upper GI Handling of Branded vs. Generic Alendronate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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MK0217, alendronate sodium / Duration of Treatment: 1 Month

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2006_050

Identifier Type: -

Identifier Source: org_study_id