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

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.

Study Overview

• Status: Completed
• Conditions: Other Osteoporosis
• Intervention / Treatment: Drug: Placebo tablet; Drug: Risedronate

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Concord, Australia
    • Research Facility
  • Heidelburg, Australia
    • Research Facility
• Belgium
  • Leuven, Belgium
    • Research Facility
• Czech Republic
  • Prague, Czech Republic
    • Research Site
• France
  • Angers, France
    • Research Facility
  • Lyon, France
    • Research Site
• Hungary
  • Budapest, Hungary
    • Research Site
  • Budapest, Hungary
    • Research Facility
• Lebanon
  • Beirut, Lebanon
    • Research Site
• Netherlands
  • Rotterdam, Netherlands
    • Research Site
• Poland
  • Bialystok, Poland
    • Research Site
  • Warsaw, Poland
    • Research Site
  • Wroclaw, Poland
    • Research Site
• United Kingdom
  • London, United Kingdom
    • Research Site
  • Newcastle, United Kingdom
    • Research Site
  • Sheffield, United Kingdom
    • Research Site
• United States
  • California
    • Palm Desert, California, United States, 92260
      • Research Site
  • Colorado
    • Lakewood, Colorado, United States, 80227
      • Research Site
  • Florida
    • Stuart, Florida, United States, 34996
      • Research Site
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Research Facility
  • Oregon
    • Portland, Oregon, United States, 97239
      • Research Site
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Documented osteoporosis of the femoral neck and lumbar spine

Exclusion Criteria:

• BMI greater than or equal to 35

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.	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).	Baseline to 24 Months/Endpoint

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.	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).	Baseline to Month 6
Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.	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).	Baseline to Month 12
Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.	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).	Baseline to Month 24
Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.	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).	Baseline to Month 6
Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.	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).	Baseline to Month 12
Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.	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).	Baseline to Month 24
Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.	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).	Baseline to 24 Months/Endpoint
Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.	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	Baseline to Month 6
Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.	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	Baseline to Month 12
Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.	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	Baseline to Month 24
Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.	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	Baseline to 24 Months/Endpoint
Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.	DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.	Baseline to Month 6
Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.	DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.	Baseline to Month 12
Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.	DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.	Baseline to Month 24
Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.	DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.	Baseline to 24 Months/Endpoint
Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.		Baseline to Month 3
Percent Change From Baseline in CTx, Month 6, ITT Population.		Baseline to Month 6
Percent Change From Baseline in CTx, Month 12, ITT Population.		Baseline to Month 12
Percent Change From Baseline in CTx, Month 24, ITT Population.		Baseline to Month 24
Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.		Baseline to 24 Months/Endpoint
Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.		Baseline to Month 3
Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.		Baseline to Month 6
Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.		Baseline to Month 12
Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.		Baseline to Month 24
Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.		Baseline to 24 Months/Endpoint
Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.		Baseline to Month 3
Percent Change From Baseline in BAP, Month 6, ITT Population.		Baseline to Month 6
Percent Change From Baseline in BAP, Month 12, ITT Population.		Baseline to Month 12
Percent Change From Baseline in BAP, Month 24, ITT Population.		Baseline to Month 24
Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.		Baseline to 24 Months/Endpoint
Change From Baseline in Body Height, Month 12, ITT Population.		Baseline to Month 12
Change From Baseline in Body Height, Month 24, ITT Population.		Baseline to Month 24
Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.		Baseline to 24 Months/Endpoint
Percent of Responders Lumbar Spine BMD, Month 24, ITT Population	responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24	Baseline to Month 24
Cumulative Incidence of Fractures, 12 Months, ITT Population	Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year	Baseline to Month 12
Cumulative Incidence of Fractures, 24 Months, ITT Population	Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years	Baseline to Month 24

Collaborators and Investigators

• Sponsor: Warner Chilcott
• Collaborators: Sanofi
• Investigators: Study Director: Dietrich Wenderoth, MD, Procter and Gamble

Publications and helpful links

General Publications

• Boonen S, Lorenc RS, Wenderoth D, Stoner KJ, Eusebio R, Orwoll ES. Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study. Bone. 2012 Sep;51(3):383-8. doi: 10.1016/j.bone.2012.06.016. Epub 2012 Jun 30.

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (ACTUAL): May 1, 2007
• Study Completion (ACTUAL): May 1, 2007

Study Registration Dates

• First Submitted: February 11, 2008
• First Submitted That Met QC Criteria: February 11, 2008
• First Posted (ESTIMATE): February 21, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 28, 2011
• Last Update Submitted That Met QC Criteria: September 20, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Risedronic Acid
• Other Study ID Numbers: 2001092 and 2001092 OL