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RISEDRONATE

Phase 3

OSTEOPOROSIS, POSTMENOPAUSAL | Small molecule | Endocrine |Sanofi|Last Updated: Feb 17, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment321
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00353080Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal WomenPHASE3 COMPLETED 171 — — Dec 1, 2002Apr 1, 2005Dec 15, 20095 Finland, Netherlands +3
NCT00351091Risedronate in Postmenopausal Women With Low Bone DensityPHASE2 COMPLETED 150 — — Nov 1, 2002Jun 1, 2003Feb 17, 2012 - —
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Study Endpoints
Primary Endpoints
Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA.
Urine NTX at week 4 of month 6
Secondary Endpoints
Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA)
Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24
Percent changes in bone turnover markers after 12 and 24 months of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
risedronate (HMR4003)DRUG -
RISEDRONATEDRUG -
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Eligibility Criteria
Age Range45 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Ambulatory, healthy postmenopausal women with * 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 y...

Countries:FinlandNetherlandsNorwaySpainSweden
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