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Parathyroid hormone

Phase 3

Disruption or Dehiscence of Closure of Sternum or Sternotomy | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 2, 2014

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 Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01466829Treatment With PTH After Sternotomy in Cardiac Surgery PatientsPHASE3 COMPLETED 20 — — Oct 1, 2012Mar 1, 2014Jun 2, 20141 Denmark
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Study Endpoints
Primary Endpoints
Computer Tomography
6 weeks (± 1 week), 3 months (± 2 weeks) and 6 months (± 2 weeks)

Change in density of the fracture in the sternum at different time frames compared with baseline at 6 weeks.

Secondary Endpoints
Questionnaires
Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
Journal parameters
Baseline, 6 weeks (± 1 week), 3 months (± 2 weeks), 6 months (± 2 weeks)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
ControlPLACEBO_COMPARATORControl patients treated with placebo.
InterventionACTIVE_COMPARATORDaily injection with Parathyroid hormone
Interventions
NameTypeDescription
Parathyroid hormoneDRUG100 microgram daily. S.c
PlaceboDRUGPlacebo; saline injection.
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Eligibility Criteria
Age Range50 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Full sternotomy * Not in chronic, systemic corticosteroid treatment. * No Plavix treatment 5 days prior to surgery * No known bone metabolic diseases. * Replete vitamin D status (plasma 25-hydroxyvitamin D \>50 nmol/l) * Normal serum levels of Calcium, Phosphate, inorganic, al...

Countries:Denmark
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