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

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 osteoporosis followed by a two year follow-up study.

Intervention(s) in this Clinical Trial

• 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

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: Risedronate
  • 35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years

Primary Measures

• Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
  • Time Frame: Baseline to 24 Months/Endpoint
    Safety Issue?: Yes

Secondary Measures

• Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
  • Time Frame: Baseline to Month 6
    Safety Issue?: Yes
• Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
  • Time Frame: Baseline to Month 12
    Safety Issue?: Yes
• Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
  • Time Frame: Baseline to Month 24
    Safety Issue?: Yes
• Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
  • Time Frame: Baseline to Month 6
    Safety Issue?: Yes
• Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
  • Time Frame: Baseline to Month 12
    Safety Issue?: Yes
• Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.
  • Time Frame: Baseline to Month 24
    Safety Issue?: Yes
• Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.
  • Time Frame: Baseline to 24 Months/Endpoint
    Safety Issue?: Yes
• Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.
  • Time Frame: Baseline to Month 6
    Safety Issue?: Yes
• Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.
  • Time Frame: Baseline to Month 12
    Safety Issue?: Yes
• Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.
  • Time Frame: Baseline to Month 24
    Safety Issue?: Yes
• Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.
  • Time Frame: Baseline to 24 Months/Endpoint
    Safety Issue?: Yes
• Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.
  • Time Frame: Baseline to Month 6
    Safety Issue?: Yes
• Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.
  • Time Frame: Baseline to Month 12
    Safety Issue?: Yes
• Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.
  • Time Frame: Baseline to Month 24
    Safety Issue?: Yes
• Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.
  • Time Frame: Baseline to 24 Months/Endpoint
    Safety Issue?: Yes
• Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
  • Time Frame: Baseline to Month 3
    Safety Issue?: Yes
• Percent Change From Baseline in CTx, Month 6, ITT Population.
  • Time Frame: Baseline to Month 6
    Safety Issue?: Yes
• Percent Change From Baseline in CTx, Month 12, ITT Population.
  • Time Frame: Baseline to Month 12
    Safety Issue?: Yes
• Percent Change From Baseline in CTx, Month 24, ITT Population.
  • Time Frame: Baseline to Month 24
    Safety Issue?: Yes
• Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
  • Time Frame: Baseline to 24 Months/Endpoint
    Safety Issue?: Yes
• Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
  • Time Frame: Baseline to Month 3
    Safety Issue?: Yes
• Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
  • Time Frame: Baseline to Month 6
    Safety Issue?: Yes
• Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
  • Time Frame: Baseline to Month 12
    Safety Issue?: Yes
• Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
  • Time Frame: Baseline to Month 24
    Safety Issue?: Yes
• Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
  • Time Frame: Baseline to 24 Months/Endpoint
    Safety Issue?: Yes
• Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
  • Time Frame: Baseline to Month 3
    Safety Issue?: Yes
• Percent Change From Baseline in BAP, Month 6, ITT Population.
  • Time Frame: Baseline to Month 6
    Safety Issue?: Yes
• Percent Change From Baseline in BAP, Month 12, ITT Population.
  • Time Frame: Baseline to Month 12
    Safety Issue?: Yes
• Percent Change From Baseline in BAP, Month 24, ITT Population.
  • Time Frame: Baseline to Month 24
    Safety Issue?: Yes
• Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
  • Time Frame: Baseline to 24 Months/Endpoint
    Safety Issue?: Yes
• Change From Baseline in Body Height, Month 12, ITT Population.
  • Time Frame: Baseline to Month 12
    Safety Issue?: Yes
• Change From Baseline in Body Height, Month 24, ITT Population.
  • Time Frame: Baseline to Month 24
    Safety Issue?: Yes
• Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
  • Time Frame: Baseline to 24 Months/Endpoint
    Safety Issue?: Yes
• Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
  • Time Frame: Baseline to Month 24
    Safety Issue?: No
• Cumulative Incidence of Fractures, 12 Months, ITT Population
  • Time Frame: Baseline to Month 12
    Safety Issue?: No
• Cumulative Incidence of Fractures, 24 Months, ITT Population
  • Time Frame: Baseline to Month 24
    Safety Issue?: No

Inclusion Criteria:

• Documented osteoporosis of the femoral 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 Investigator: Warner Chilcott Industry

Overall Clinical Trial Officials and Contacts

Dietrich Wenderoth, MD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on February 12, 2012

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