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Actonel

Phase 3

Osteoporosis | Small molecule | Endocrine |Amgen Inc.|Last Updated: Jul 28, 2020

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment870
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00919711Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate TherapyPHASE3 COMPLETED 870Sep 1, 2009Mar 5, 2012Jul 28, 2020 -
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Study Endpoints
Primary Endpoints
Total Hip BMD Percent Change From Baseline at Month 12
Baseline to month 12

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry

Secondary Endpoints
Serum CTX Percent Change From Baseline at Month 1
Baseline to month 1
Femoral Neck BMD Percent Change From Baseline at Month 12
Baseline to month 12
Lumbar Spine BMD Percent Change From Baseline at Month 12
Baseline to month 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Denosumab 60 mgEXPERIMENTAL -
Risedronate 150 mg QMACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Actonel®DRUGOral Actonel® (Risedronate) in total a 150mg per month (one 75mg tablet to be taken on each of 2 consecutive days per month).
DenosumabDRUGDenosumab 60 mg, once every 6 months, Subcutaneous
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Eligibility Criteria
Age Range55 Years — N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Ambulatory, post menopausal women aged 55 years or older at screening. Have received their first prescription of daily or weekly alendronate therapy, for the treatment for post menopausal osteoporosis at least 1 month prior to screening. Use of raloxifene, calcitonin or hormon...

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Competitive Landscape -Osteoporosis 8 trials