NCT00619957

Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis

Two-year Study to Determine the Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis for 2 Years Followed by a 2 Year Open Label Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Male
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.

Conditions

• Other Osteoporosis

Interventions

Type	Name	Description
DRUG	Placebo tablet	one placebo once a week for two years followed by one 35 mg risedronate once a week for two years
DRUG	Risedronate	one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years

Timeline

• Start date: 2002-06-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2008-02-21
• Last updated: 2011-10-28
• Results posted: 2011-10-28

Locations

23 sites across 10 countries: United States, Australia, Belgium, Czechia, France, Hungary, Lebanon, Netherlands, Poland, United Kingdom