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
1 other identifier
interventional
285
10 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2002
Longer than P75 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 11, 2008
CompletedFirst Posted
Study publicly available on registry
February 21, 2008
CompletedResults Posted
Study results publicly available
October 28, 2011
CompletedOctober 28, 2011
September 1, 2011
4.9 years
February 11, 2008
May 23, 2011
September 20, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (36)
Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
Baseline to Month 6
Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
Baseline to Month 12
Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
Baseline to Month 24
Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
Baseline to Month 6
Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
Baseline to Month 12
- +31 more secondary outcomes
Study Arms (2)
1
PLACEBO COMPARATORPlacebo tablet once a week for 2 years followed by once a week Risedronate for 2 years
Risedronate
EXPERIMENTAL35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years
Interventions
one placebo once a week for two years followed by one 35 mg risedronate once a week for two years
one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years
Eligibility Criteria
You may qualify if:
- Documented osteoporosis of the femoral neck and lumbar spine
You may not qualify if:
- BMI greater than or equal to 35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Warner Chilcottlead
- Sanoficollaborator
Study Sites (23)
Research Site
Palm Desert, California, 92260, United States
Research Site
Lakewood, Colorado, 80227, United States
Research Site
Stuart, Florida, 34996, United States
Research Site
St Louis, Missouri, 63110, United States
Research Facility
Cincinnati, Ohio, 45219, United States
Research Site
Portland, Oregon, 97239, United States
Research Site
Wyomissing, Pennsylvania, 19610, United States
Research Facility
Concord, Australia
Research Facility
Heidelburg, Australia
Research Facility
Leuven, Belgium
Research Site
Prague, Czechia
Research Facility
Angers, France
Research Site
Lyon, France
Research Facility
Budapest, Hungary
Research Site
Budapest, Hungary
Research Site
Beirut, Lebanon
Research Site
Rotterdam, Netherlands
Research Site
Bialystok, Poland
Research Site
Warsaw, Poland
Research Site
Wroclaw, Poland
Research Site
London, United Kingdom
Research Site
Newcastle, United Kingdom
Research Site
Sheffield, United Kingdom
Related Publications (1)
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.
PMID: 22750403DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Grexan Wulff, Manager Regulatory Affairs
- Organization
- Warner Chilcott
Study Officials
- STUDY DIRECTOR
Dietrich Wenderoth, MD
Procter and Gamble
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2008
First Posted
February 21, 2008
Study Start
June 1, 2002
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
October 28, 2011
Results First Posted
October 28, 2011
Record last verified: 2011-09