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Ibandronate

Phase 3

Postmenopausal Osteoporosis | Small molecule | Endocrine |Amgen Inc.|Last Updated: Feb 11, 2013

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 Enrollment833
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00936897A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly BisphosphonatesPHASE3 COMPLETED 833 — — Jul 1, 2009Jan 1, 2012Feb 11, 2013 - —
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Study Endpoints
Primary Endpoints
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
Baseline to month 12
Secondary Endpoints
Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1
Baseline to month 1
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12
Baseline to Month 12
Lumbar Spine Bone Mineral Density 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
IbandronateACTIVE_COMPARATORIbandronate 150mg PO QM (tablet)
DenosumabEXPERIMENTALdenosumab 60mg Subcutaneous Q6M (pre-filled syringe)
Interventions
NameTypeDescription
IbandronateDRUGIbandronate 150mg PO QM (tablet)
DenosumabDRUGdenosumab 60mg SC Q6M (pre-filled syringe)
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Eligibility Criteria
Age Range55 Years — N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Ambulatory, postmenopausal women (based on medical history) 55 years or older at screening * Postmenopause will be defined as no vaginal bleeding or spotting for at least 12 months * If the subject is 55 - 59 years old and there is uncertainty regarding menopausal status, conf...

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