Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
NCT ID: NCT00619957
Last Updated: 2011-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
285 participants
INTERVENTIONAL
2002-06-30
2007-05-31
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
DOUBLE
Study Groups
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1
Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years
Placebo tablet
one placebo once a week for two years followed by one 35 mg risedronate once a week for two years
Risedronate
35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years
Risedronate
one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years
Interventions
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Placebo tablet
one placebo once a week for two years followed by one 35 mg risedronate once a week for two years
Risedronate
one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
30 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
Warner Chilcott
INDUSTRY
Responsible Party
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Principal Investigators
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Dietrich Wenderoth, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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Research Site
Palm Desert, California, United States
Research Site
Lakewood, Colorado, United States
Research Site
Stuart, Florida, United States
Research Site
St Louis, Missouri, United States
Research Facility
Cincinnati, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Wyomissing, Pennsylvania, United States
Research Facility
Concord, , Australia
Research Facility
Heidelburg, , Australia
Research Facility
Leuven, , Belgium
Research Site
Prague, , Czechia
Research Facility
Angers, , France
Research Site
Lyon, , France
Research Facility
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Beirut, , Lebanon
Research Site
Rotterdam, , Netherlands
Research Site
Bialystok, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
London, , United Kingdom
Research Site
Newcastle, , United Kingdom
Research Site
Sheffield, , United Kingdom
Countries
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References
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Boonen S, Lorenc RS, Wenderoth D, Stoner KJ, Eusebio R, Orwoll ES. Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study. Bone. 2012 Sep;51(3):383-8. doi: 10.1016/j.bone.2012.06.016. Epub 2012 Jun 30.
Other Identifiers
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2001092 and 2001092 OL
Identifier Type: -
Identifier Source: org_study_id