Risedronate in the Prevention of Osteoporosis in Postmenopausal Women
A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 35-mg Risedronate Administered Once a Week in the Prevention of Osteoporosis in Postmenopausal Women
1 other identifier
interventional
260
1 country
1
Brief Summary
Primary Objective:
- To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal. Secondary objectives:
- To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1 year of treatment in women who are 0.5-5 years postmenopausal
- To assess the general safety of 35-mg risedronate administered once weekly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 21, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedApril 29, 2009
April 1, 2009
1.8 years
November 21, 2006
April 28, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change from baseline to Month12(endpoint) in lumbar spine BMD with imputation using LOCF principle.
Secondary Outcomes (3)
Percent change from baseline to Months 6 and 12 in lumbar spine BMD
and the percent change from baseline to Months 6, 12, and endpoint in total proximal femur, femoral neck, and trochanter BMD
Reported adverse events and changes in routine clinical laboratory tests, vital signs, and physical examinations.
Interventions
Eligibility Criteria
You may not qualify if:
- Be postmenopausal for 0.5-5 years.Menopause is defined as 12 months without menses, based on medical history. Subjects who are post-menopausal secondary to bilateral oophorectomy must have serum FSH \>40 mIU/mL and estradiol \<20 pg/mL.
- Subjects with 3 contiguous lumbar spine vertebral bodies (L1-L4) without fracture or degenerative disease.
- Lumbar spine BMD mean value \> 0.772g/cm2 (Hologic) or \>0.880 g/cm2 (Lunar).
- Subjects with adequate lumbar spine BMD but osteoporotic by total proximal femur BMD (\<0.637 g/cm2 \[Hologic\]) or \<0.694 g/cm2 \[Lunar\]) as determined by dual-energy x-ray absorptiometry (DXA)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Procter and Gamblecollaborator
Study Sites (1)
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ellen Matzkin
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 21, 2006
First Posted
November 22, 2006
Study Start
September 1, 2002
Primary Completion
June 1, 2004
Study Completion
June 1, 2004
Last Updated
April 29, 2009
Record last verified: 2009-04