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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00619957
First received: February 11, 2008
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Other Osteoporosis
Drug: Placebo tablet
Drug: Risedronate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population. [ Time Frame: Baseline to 24 Months/Endpoint ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population. [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in CTx, Month 6, ITT Population. [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in CTx, Month 12, ITT Population. [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in CTx, Month 24, ITT Population. [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population. [ Time Frame: Baseline to 24 Months/Endpoint ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in NTx/Cr, Month 6, ITT Population. [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in NTx/Cr, Month 12, ITT Population. [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in NTx/Cr, Month 24, ITT Population. [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population. [ Time Frame: Baseline to 24 Months/Endpoint ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population. [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in BAP, Month 6, ITT Population. [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in BAP, Month 12, ITT Population. [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in BAP, Month 24, ITT Population. [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population. [ Time Frame: Baseline to 24 Months/Endpoint ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Body Height, Month 12, ITT Population. [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Body Height, Month 24, ITT Population. [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population. [ Time Frame: Baseline to 24 Months/Endpoint ] [ Designated as safety issue: Yes ]
  • Percent of Responders Lumbar Spine BMD, Month 24, ITT Population [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year

  • Cumulative Incidence of Fractures, 24 Months, ITT Population [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years


Enrollment: 285
Study Start Date: June 2002
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years
Drug: Placebo tablet
one placebo once a week for two years followed by one 35 mg risedronate once a week for two 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
Drug: Risedronate
one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented osteoporosis of the femoral neck and lumbar spine

Exclusion Criteria:

  • BMI greater than or equal to 35
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619957

  Show 23 Study Locations
Sponsors and Collaborators
Warner Chilcott
Sanofi
Investigators
Study Director: Dietrich Wenderoth, MD Procter and Gamble
  More Information

No publications provided by Warner Chilcott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00619957     History of Changes
Other Study ID Numbers: 2001092 and 2001092 OL
Study First Received: February 11, 2008
Results First Received: May 23, 2011
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Etidronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014