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Upper GI Handling of Branded vs. Generic Alendronate

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ClinicalTrials.gov Identifier: NCT00400530
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : November 17, 2006
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: MK0217, alendronate sodium / Duration of Treatment: 1 Month Drug: Comparator: Alendronate-Teva / Duration of Treatment: 1 Month Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets
Study Start Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Gamma camera imaging of tablet dissolution in oesophagus

Secondary Outcome Measures :
  1. Gamma camera dissolution of tablets in stomach


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400530


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier: NCT00400530     History of Changes
Other Study ID Numbers: 2006_050
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: November 17, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs