A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)
NCT ID: NCT00092027
Last Updated: 2024-08-14
Study Results
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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COMPLETED
PHASE3
454 participants
INTERVENTIONAL
2003-03-19
2004-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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MK0217, alendronate sodium/Duration of Treatment: 6 months
Comparator: placebo / Duration of Treatment: 6 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Esophageal abnormalities
* Upper gastrointestinal symptoms that are not relieved with medication
* Metabolic bone disease (example - vitamin D deficiency)
* Medications that would affect the breakdown or build-up of bone
25 Years
FEMALE
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Cryer B, Binkley N, Simonelli C, Lewiecki EM, Lanza F, Chen E, Petruschke RA, Mullen C, de Papp AE. A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis. Am J Geriatr Pharmacother. 2005 Sep;3(3):127-36. doi: 10.1016/s1543-5946(05)80019-4.
Other Identifiers
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MK0217-219
Identifier Type: -
Identifier Source: secondary_id
2004_017
Identifier Type: -
Identifier Source: secondary_id
0217-219
Identifier Type: -
Identifier Source: org_study_id
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