Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women
NCT ID: NCT00353080
Last Updated: 2009-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
171 participants
INTERVENTIONAL
2002-12-31
2005-04-30
Brief Summary
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To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption
To confirm general safety of 5 mg daily risedronate as compared to placebo
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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risedronate (HMR4003)
Eligibility Criteria
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Inclusion Criteria
* Natural menopause and more than 5 years after their last menstrual period
* or surgical menopause and more than 5 years after surgery
* osteopenia (lumbar spine T score between 1 and 2.5 SD below the mean value in normal young women).
* With at least one risk factor for osteoporosis
Exclusion Criteria
45 Years
FEMALE
No
Sponsors
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Procter and Gamble
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Välimäki Matti, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Endocrinology, Helsinki University Central Hospital, Helsinki, Finland
Locations
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Sanofi-Aventis
Helsinki, , Finland
Sanofi-Aventis
Gouda, , Netherlands
Sanofi-Aventis
Oslo, , Norway
Sanofi-Aventis
Madrid, , Spain
Sanofi-Aventis
Stockholm, , Sweden
Countries
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References
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Valimaki MJ, Farrerons-Minguella J, Halse J, Kroger H, Maroni M, Mulder H, Munoz-Torres M, Saaf M, Snorre Ofjord E. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Clin Ther. 2007 Sep;29(9):1937-49. doi: 10.1016/j.clinthera.2007.09.017.
Other Identifiers
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HMR4003B/3001
Identifier Type: -
Identifier Source: secondary_id
EFC6064
Identifier Type: -
Identifier Source: org_study_id