Recent Updates
Recently added Catalysts

Kyphoplasty

Phase 3

Osteoporotic Vertebral Compression Fractures | Unknown | Musculoskeletal |Cardinal Health, Inc.|Last Updated: Aug 18, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment112
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00279877Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty TrialPHASE3 COMPLETED 112 — — May 1, 2005Sep 1, 2011Aug 18, 20161 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Back specific functional status(Roland)
12 mo
Pain
12 mo
Secondary Endpoints
Health status outcome measure(SF-36)
12 mo
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
vertebroplastyACTIVE_COMPARATORvertebroplasty
kyphoplastyACTIVE_COMPARATORkyphoplasty
Interventions
NameTypeDescription
KyphoplastyPROCEDUREkyphoplasty
Unlock Study Design Details
Eligibility Criteria
Age Range50 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites1

* \> or = 50 years of age * Compression fracture (T4-L5)within previous 12 mo. * Pain from compression fracture * No malignant tumor * No back surgery

Countries:United States
Unlock Eligibility Criteria