NCT00400530

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
Last Updated

November 17, 2006

Status Verified

November 1, 2006

First QC Date

November 16, 2006

Last Update Submit

November 16, 2006

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Gamma camera imaging of tablet dissolution in oesophagus

Secondary Outcomes (1)

  • Gamma camera dissolution of tablets in stomach

Interventions

MK0217, alendronate sodium / Duration of Treatment: 1 MonthDRUG
Comparator: Alendronate-Teva / Duration of Treatment: 1 MonthDRUG

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of drug hypersensitivity
  • Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporosis

Interventions

AlendronateDuration of Therapy

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 17, 2006

Study Start

December 1, 2005

Last Updated

November 17, 2006

Record last verified: 2006-11