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PTH/Calcium

Phase 3

Osteoporosis | Small molecule | Endocrine |Takeda Pharmaceutical Company Limited|Last Updated: May 25, 2021

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment374
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00172172Calcium Supplementation in Postmenopausal WomenPHASE3 COMPLETED 374Jan 10, 2004Mar 11, 2005May 25, 202127 United States, Argentina +1
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Study Endpoints
Primary Endpoints
Evaluate subjects treated with ALX1-11 (no calcium supplementation) increase in BMD is less than those treated with ALX1-11 (receiving calcium supplementation).
6 months
Primary efficacy variable is the percentage change from baseline of lumbar vertebral BMDmeasured by DXA.
6 months
Secondary Endpoints
BMC,
6 months
vBMD,
6 months
the incidence of clinical fractures,
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALPTH 100 mcg and 700 mg calcium
2EXPERIMENTALPTH 100 mcg and placebo
3PLACEBO_COMPARATORPlacebo and 700 mg calcium
Interventions
NameTypeDescription
PTH/CalciumDRUGPTH(1-84) subcutaneous injection and calcium 700 mg oral
PTH/placeboDRUGPTH (1-84) injected subcutaneously and placebo provided orally
placeboDRUGPlacebo injected subcutaneously and 700 mg calcium orally
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Eligibility Criteria
Age Range45 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Women who are capable of understanding and giving written, voluntary informed consent before the clinical study screening visit * Women with the ability to self-administer a daily injection or having a designee who will give the injections * Women who are postmenopausal with a...

Countries:United StatesArgentinaMexico
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Competitive Landscape -Osteoporosis 8 trials