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Raloxifene

Phase 3

Osteoporosis, Postmenopausal | Small molecule | Endocrine |Eli Lilly and Company|Last Updated: May 1, 2008

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment7,705
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00670319Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With OsteoporosisPHASE3 COMPLETED 7,705 — — Nov 1, 1994Sep 1, 1999May 1, 200825 United States, Argentina +23
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Study Endpoints
Primary Endpoints
To establish the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without prevalent vertebral fractures by spinal x-ray.
Screening, 24, 36, and 72 months
To establish the effect of long-term treatment with raloxifene, compared with placebo, on lumbar spine and femoral neck bone mineral density (BMD) in postmenopausal women with osteoporosis.
Screening, baseline, 12, 24, 36, 48, 60 and 72 months
To establish the safety of chronic administration of raloxifene in postmenopausal women with osteoporosis. Adverse events (AEs), physical exam (PE), EKG, mammograms and laboratory tests will be used to assess safety in the patients.
AEs: throughout the trial. PEs: Randomization, 12, 24, 36, 48, 60, 72 months. ECG: Randomization, 24, 48, 72 months. Mammograms: Randomization, 12, 24, 36, 48, 60, 72 months. Labs: Randomization, baseline, 6, 12, 18, 24, 30, 36, 48, 60, 72 months.
Secondary Endpoints
To establish the effect of long-term treatment with raloxifene, compared with placebo, on total body bone mineral content and radial BMD in postmenopausal women with osteoporosis.
Baseline, 24 and 72 months
To establish the effect of raloxifene, compared with placebo, on the rates of new nonvertebral fractures alone & of nonvertebral & vertebral fractures combined in postmenopausal women with osteoporosis by spinal x-ray & assessment of clinical fractures.
Spinal X-rays: Screening, 24, 36 and 72 months. Assessment of clinical fractures: throughout the trial
To establish the effect of long-term treatment with raloxifene, compared with placebo, on biochemical markers of bone metabolism in postmenopausal women with osteoporosis.
Randomization, baseline, 6, 12, 24, 36, and 72 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALRaloxifene HCL 60 mg orally once a day
2EXPERIMENTALRaloxifene HCL 120 mg orally once a day
3PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Raloxifene HCLDRUGRaloxifene HCL 60 mg orally once daily
PlaceboDRUGPlacebo one tab orally per day
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Eligibility Criteria
Age RangeN/A — 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Ambulatory postmenopausal women free of severe or chronically disabling conditions, have a life expectancy of at least 5 years, be expected to remain ambulatory throughout the entire study, and be expected to return for follow-up visits. * Women who have had their last menstru...

Countries:United StatesArgentinaAustraliaAustriaBelgiumCanadaCzechiaDenmarkFinlandFranceGermanyHungaryIsraelItalyMexicoNetherlandsNew ZealandNorwayPolandSingaporeSlovakiaSloveniaSpainSwedenUnited Kingdom
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