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OpenTrials
Completed

NCT Number: NCT00619957

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

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.

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Key information

Conditions

Other Osteoporosis

Age range

30 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Research Facility, Concord, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented osteoporosis of the femoral neck and lumbar spine

Exclusion criteria

  • BMI greater than or equal to 35

Treatment and study plan

Placebo Tablet

Drug

one placebo once a week for two years followed by one 35 mg risedronate once a week for two years

risedronate

Drug

one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.

    Time frame: Baseline to Month 3

  17. Percent Change From Baseline in CTx, Month 6, ITT Population.

    Time frame: Baseline to Month 6

  18. Percent Change From Baseline in CTx, Month 12, ITT Population.

    Time frame: Baseline to Month 12

  19. Percent Change From Baseline in CTx, Month 24, ITT Population.

    Time frame: Baseline to Month 24

  20. Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.

    Time frame: Baseline to 24 Months/Endpoint

  21. Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.

    Time frame: Baseline to Month 3

  22. Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.

    Time frame: Baseline to Month 6

  23. Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.

    Time frame: Baseline to Month 12

  24. Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.

    Time frame: Baseline to Month 24

  25. Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.

    Time frame: Baseline to 24 Months/Endpoint

  26. Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.

    Time frame: Baseline to Month 3

  27. Percent Change From Baseline in BAP, Month 6, ITT Population.

    Time frame: Baseline to Month 6

  28. Percent Change From Baseline in BAP, Month 12, ITT Population.

    Time frame: Baseline to Month 12

  29. Percent Change From Baseline in BAP, Month 24, ITT Population.

    Time frame: Baseline to Month 24

  30. Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.

    Time frame: Baseline to 24 Months/Endpoint

  31. Change From Baseline in Body Height, Month 12, ITT Population.

    Time frame: Baseline to Month 12

  32. Change From Baseline in Body Height, Month 24, ITT Population.

    Time frame: Baseline to Month 24

  33. Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.

    Time frame: Baseline to 24 Months/Endpoint

  34. 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

  35. Cumulative Incidence of Fractures, 12 Months, ITT Population

    Time frame: Baseline to Month 12

    Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year

  36. Cumulative Incidence of Fractures, 24 Months, ITT Population

    Time frame: Baseline to Month 24

    Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Collaborators

  • Sanofi

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Feb 21, 2008
Registry last updated
Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.