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teriparatide 20 micrograms/day

Phase 3

Osteoporosis, Postmenopausal | Small molecule | Endocrine |Eli Lilly and Company|Last Updated: Oct 12, 2007

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 Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00542984Comparison Medications in the Treatment of Postmenopausal Women With OsteoporosisPHASE3 COMPLETED 70 — — Aug 1, 2003Nov 1, 2004Oct 12, 20071 South Korea
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Study Endpoints
Primary Endpoints
To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD.
Secondary Endpoints
To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day with the effect of calcitonin 100 IU/day on change in femoral neck and total hip BMD
Compare effect of teriparatide 20 micrograms/day with the effect of calcitonin 100 IU/day on change in biochemical bone markers (bone specific alkaline phosphatase and Osteocalcin) at 3 and 6 months after treatment with teriparatide versus calcitonin.
Safety as determined by physical examinations, vital signs, clinical labs and reports of adverse events
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AACTIVE_COMPARATORteriparatide 20 micrograms/day subcutaneous
BACTIVE_COMPARATORsalmon calcitonin 100 IU/day subcutaneous
Interventions
NameTypeDescription
teriparatide 20 micrograms/day subcutaneousDRUG -
salmon calcitonin 100 IU/day subcutaneousDRUG -
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Eligibility Criteria
Age Range55 Years — 85 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Ambulatory, postmenopausal women aged 55-85 years (at least 3 years have elapsed after menopausal) are included at the time of entry into the trial. They have to be free of severe or chronically disabling conditions other than osteoporosis. * The patient should have a document...

Countries:South Korea
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