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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2007

Interventions

  • 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

  • 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

Clinical Trial Outcome Measures

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
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).

Secondary Measures

  • Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
    • Time Frame: Baseline to Month 6
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
  • Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
    • Time Frame: Baseline to Month 12
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
  • Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
    • Time Frame: Baseline to Month 24
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
  • Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
    • Time Frame: Baseline to Month 6
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD – 0.031).
  • Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
    • Time Frame: Baseline to Month 12
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD – 0.031).
  • Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.
    • Time Frame: Baseline to Month 24
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD – 0.031).
  • Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.
    • Time Frame: Baseline to 24 Months/Endpoint
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD – 0.031).
  • Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.
    • Time Frame: Baseline to Month 6
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD[lunar]) – 0.008
  • Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.
    • Time Frame: Baseline to Month 12
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) – 0.008
  • Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.
    • Time Frame: Baseline to Month 24
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) – 0.008
  • Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.
    • Time Frame: Baseline to 24 Months/Endpoint
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) – 0.008
  • Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.
    • Time Frame: Baseline to Month 6
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
  • Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.
    • Time Frame: Baseline to Month 12
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
  • Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.
    • Time Frame: Baseline to Month 24
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
  • Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.
    • Time Frame: Baseline to 24 Months/Endpoint
    • DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
  • Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
    • Time Frame: Baseline to Month 3
  • Percent Change From Baseline in CTx, Month 6, ITT Population.
    • Time Frame: Baseline to Month 6
  • Percent Change From Baseline in CTx, Month 12, ITT Population.
    • Time Frame: Baseline to Month 12
  • Percent Change From Baseline in CTx, Month 24, ITT Population.
    • Time Frame: Baseline to Month 24
  • Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
    • Time Frame: Baseline to 24 Months/Endpoint
  • Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
    • Time Frame: Baseline to Month 3
  • Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
    • Time Frame: Baseline to Month 6
  • Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
    • Time Frame: Baseline to Month 12
  • Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
    • Time Frame: Baseline to Month 24
  • Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
    • Time Frame: Baseline to 24 Months/Endpoint
  • Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
    • Time Frame: Baseline to Month 3
  • Percent Change From Baseline in BAP, Month 6, ITT Population.
    • Time Frame: Baseline to Month 6
  • Percent Change From Baseline in BAP, Month 12, ITT Population.
    • Time Frame: Baseline to Month 12
  • Percent Change From Baseline in BAP, Month 24, ITT Population.
    • Time Frame: Baseline to Month 24
  • Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
    • Time Frame: Baseline to 24 Months/Endpoint
  • Change From Baseline in Body Height, Month 12, ITT Population.
    • Time Frame: Baseline to Month 12
  • Change From Baseline in Body Height, Month 24, ITT Population.
    • Time Frame: Baseline to Month 24
  • Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
    • Time Frame: Baseline to 24 Months/Endpoint
  • Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
    • Time Frame: Baseline to Month 24
    • responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24
  • Cumulative Incidence of Fractures, 12 Months, ITT Population
    • Time Frame: Baseline to Month 12
    • Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year
  • Cumulative Incidence of Fractures, 24 Months, ITT Population
    • Time Frame: Baseline to Month 24
    • Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years

Participating in This Clinical Trial

Inclusion Criteria

  • Documented osteoporosis of the femoral neck and lumbar spine Exclusion Criteria:

  • BMI greater than or equal to 35

Gender Eligibility: Male

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Warner Chilcott
  • Collaborator
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dietrich Wenderoth, MD, Study Director, Procter and Gamble

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