Back to resultsEfficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
Primary Purpose
Other Osteoporosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo tablet
Risedronate
Sponsored by
About this trial
This is an interventional treatment trial for Other Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Documented osteoporosis of the femoral neck and lumbar spine
Exclusion Criteria:
- BMI greater than or equal to 35
Sites / Locations
- Research Site
- Research Site
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- Research Site
- Research Facility
- Research Site
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- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
Risedronate
Arm Description
Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years
35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
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).
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).
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
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
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
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
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.
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.
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.
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.
Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
Percent Change From Baseline in CTx, Month 6, ITT Population.
Percent Change From Baseline in CTx, Month 12, ITT Population.
Percent Change From Baseline in CTx, Month 24, ITT Population.
Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
Percent Change From Baseline in BAP, Month 6, ITT Population.
Percent Change From Baseline in BAP, Month 12, ITT Population.
Percent Change From Baseline in BAP, Month 24, ITT Population.
Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
Change From Baseline in Body Height, Month 12, ITT Population.
Change From Baseline in Body Height, Month 24, ITT Population.
Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24
Cumulative Incidence of Fractures, 12 Months, ITT Population
Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year
Cumulative Incidence of Fractures, 24 Months, ITT Population
Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years
Full Information
NCT ID
NCT00619957
First Posted
February 11, 2008
Last Updated
September 20, 2011
Sponsor
Warner Chilcott
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00619957
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years
Arm Title
Risedronate
Arm Type
Experimental
Arm Description
35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Intervention Description
one placebo once a week for two years followed by one 35 mg risedronate once a week for two years
Intervention Type
Drug
Intervention Name(s)
Risedronate
Intervention Description
one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
Description
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).
Time Frame
Baseline to 24 Months/Endpoint
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
Description
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).
Time Frame
Baseline to Month 6
Title
Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
Description
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).
Time Frame
Baseline to Month 12
Title
Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
Description
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).
Time Frame
Baseline to Month 24
Title
Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
Description
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).
Time Frame
Baseline to Month 6
Title
Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
Description
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).
Time Frame
Baseline to Month 12
Title
Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.
Description
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).
Time Frame
Baseline to Month 24
Title
Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.
Description
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).
Time Frame
Baseline to 24 Months/Endpoint
Title
Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.
Description
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
Time Frame
Baseline to Month 6
Title
Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.
Description
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
Time Frame
Baseline to Month 12
Title
Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.
Description
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
Time Frame
Baseline to Month 24
Title
Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.
Description
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
Time Frame
Baseline to 24 Months/Endpoint
Title
Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.
Description
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Time Frame
Baseline to Month 6
Title
Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.
Description
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Time Frame
Baseline to Month 12
Title
Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.
Description
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Time Frame
Baseline to Month 24
Title
Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.
Description
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Time Frame
Baseline to 24 Months/Endpoint
Title
Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
Time Frame
Baseline to Month 3
Title
Percent Change From Baseline in CTx, Month 6, ITT Population.
Time Frame
Baseline to Month 6
Title
Percent Change From Baseline in CTx, Month 12, ITT Population.
Time Frame
Baseline to Month 12
Title
Percent Change From Baseline in CTx, Month 24, ITT Population.
Time Frame
Baseline to Month 24
Title
Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
Time Frame
Baseline to 24 Months/Endpoint
Title
Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
Time Frame
Baseline to Month 3
Title
Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
Time Frame
Baseline to Month 6
Title
Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
Time Frame
Baseline to Month 12
Title
Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
Time Frame
Baseline to Month 24
Title
Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
Time Frame
Baseline to 24 Months/Endpoint
Title
Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
Time Frame
Baseline to Month 3
Title
Percent Change From Baseline in BAP, Month 6, ITT Population.
Time Frame
Baseline to Month 6
Title
Percent Change From Baseline in BAP, Month 12, ITT Population.
Time Frame
Baseline to Month 12
Title
Percent Change From Baseline in BAP, Month 24, ITT Population.
Time Frame
Baseline to Month 24
Title
Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
Time Frame
Baseline to 24 Months/Endpoint
Title
Change From Baseline in Body Height, Month 12, ITT Population.
Time Frame
Baseline to Month 12
Title
Change From Baseline in Body Height, Month 24, ITT Population.
Time Frame
Baseline to Month 24
Title
Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
Time Frame
Baseline to 24 Months/Endpoint
Title
Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
Description
responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24
Time Frame
Baseline to Month 24
Title
Cumulative Incidence of Fractures, 12 Months, ITT Population
Description
Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year
Time Frame
Baseline to Month 12
Title
Cumulative Incidence of Fractures, 24 Months, ITT Population
Description
Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years
Time Frame
Baseline to Month 24
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented osteoporosis of the femoral neck and lumbar spine
Exclusion Criteria:
BMI greater than or equal to 35
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dietrich Wenderoth, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Research Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
Facility Name
Research Site
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Facility
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Research Site
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Research Facility
City
Concord
Country
Australia
Facility Name
Research Facility
City
Heidelburg
Country
Australia
Facility Name
Research Facility
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Prague
Country
Czech Republic
Facility Name
Research Facility
City
Angers
Country
France
Facility Name
Research Site
City
Lyon
Country
France
Facility Name
Research Facility
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Beirut
Country
Lebanon
Facility Name
Research Site
City
Rotterdam
Country
Netherlands
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Warsaw
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Newcastle
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
22750403
Citation
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.
Results Reference
derived
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Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
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