Official Title: “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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

• Drug: Placebo tablet
  • one placebo once a week for two years followed by 35 mg risedronate for two years
• Drug: Risedronate
  • one 35 mg risedronate once a week for two years followed by 35 mg risedronate for two years

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years
• Experimental: 2
  • 35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Primary Measures

• Percent change from baseline in lumbar spine bone mineral density (BMD) over 24 months.
  • Time Frame: 24 months
    Safety Issue?: Yes

Secondary Measures

• Percent changes in lumbar spine BMD at all time points other than the month 24 primary efficacy time point
  • Time Frame: 24 months
    Safety Issue?: Yes

Inclusion Criteria:

• Documented osteoporosis of thefemoral neck and lumbar spine

Exclusion Criteria:

• BMI greater than or equal to 35

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Procter and Gamble

Overall Clinical Trial Officials and Contacts

Dietrich Wenderoth, MD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00619957

Study ID Number: 2001092 and 2001092 OL

ClinicalTrials.gov Identifier: NCT00619957

Health Authority: United States: Food and Drug Administration