Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover
NCT ID: NCT01249261
Last Updated: 2011-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
61 participants
INTERVENTIONAL
2001-10-31
2003-05-31
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
NONE
Study Groups
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Placebo/Risedronate
Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8
Placebo/Risedronate
placebo years 1-5 followed by 5 mg risedronate years 6 \& 7 and no drug year 8
Risedronate
Risedronate 5mg years 1-7, no drug year 8
Risedronate
5 mg/day
Interventions
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Risedronate
5 mg/day
Placebo/Risedronate
placebo years 1-5 followed by 5 mg risedronate years 6 \& 7 and no drug year 8
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Using bisphosphonates, glucocorticoids, anabolic steroids, vitamin D supplements, calcitrol, estrogen or estrogen-related drugs, progestogen, depot injection \>10,000 IU vitamin D, investigational drug
85 Years
FEMALE
No
Sponsors
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Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Herman Ellman, MD
Role: STUDY_DIRECTOR
Warner Chilcott
Locations
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Investigational Site
Concord, New South Wales, Australia
Investigational Site
Parkville, Victoria, Australia
Investigational Site
De Pintelaan 185, Gent, Belgium
Investigational Site
Hvidovre, Denmark, Denmark
Investigational Site
Oulu, Finland, Finland
Investigational Site
Siena, Italy, Italy
Investigational Site
Warsaw, Poland, Poland
Investigational Site
Warsaw, Poland, Poland
Investigational Site
Warsaw, Poland, Poland
Investigational Site
Warsaw, Poland, Poland
Investigational Site
Barcelona, Spain, Spain
Investigational Site
Madrid, Spain, Spain
Investigational Site
Gothenburg, Sweden, Sweden
Countries
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Other Identifiers
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2001079
Identifier Type: -
Identifier Source: org_study_id