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
156 participants
INTERVENTIONAL
2006-03-31
2009-06-30
Brief Summary
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The secondary objectives are to compare the percent change from Screening/Baseline between the 2 treatment groups for the following measurements:
* Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months;
* 3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 months; and
* Bone turnover markers (BTMs) of:
* fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen (CTX 1);
* serum aminoterminal propeptide of type 1 procollagen (PINP); and
* urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
risedronate
risedronate sodium 35 mg tablets (once a week dose)
2
risedronate placebo
placebo for risedronate tablets (once a week dose)
Interventions
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risedronate
risedronate sodium 35 mg tablets (once a week dose)
risedronate placebo
placebo for risedronate tablets (once a week dose)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe renal impairment
* Serum 5-hydroxy vitamin D level \< 15 ng/ml
* History of recent primary hyperparathyroidism or recent thyroid disorder
* History of any generalized bone disease
* Current use of glucocorticoids, estrogens, progestins, calcium supplements \> 1 g/day, vitamin D supplements \> 800 IU/day, parathyroid hormone (PTH), or any bisphosphonate for \> 1 month at any time within the past 6 months.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
55 Years
75 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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Marie SEBILLE, Dr
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
Paris, , France
Countries
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Other Identifiers
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EudraCT # :2005-005598-30
Identifier Type: -
Identifier Source: secondary_id
HMR4003B_3507
Identifier Type: -
Identifier Source: org_study_id