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FORTEO

Phase 1

Bone Loss | Small molecule | Musculoskeletal |Eli Lilly and Company|Last Updated: Oct 7, 2009

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 Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00277706Impact of Parathyroid Hormone (PTH) on Osseous CavityPHASE1 COMPLETED 40 — — Aug 1, 2004Jul 1, 2009Oct 7, 20091 United States
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Study Endpoints
Primary Endpoints
The primary objective of this pilot study is to determine the effect of Forteo (PTH) on periodontal regeneration.
Secondary Endpoints
The secondary objectives are to determine the effect of PTH on parameters associated with periodontal health such as attachment level, radiographic bone density and bone height, and gingival crevicular fluid levels of bone active cytokines.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FORTEOEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Periodontal surgeryPROCEDURE -
FORTEODRUGparathyroid hormone; self-administration for 6 weeks
PlaceboDRUGplacebo; self administration for 6 weeks
Vitamin D and CalciumDIETARY_SUPPLEMENTPO, QD, for six weeks
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Eligibility Criteria
Age Range30 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age range: 30 to 75 years * Sex: Male and female * Female patients must be postmenopausal (for at least 2 years), surgically sterilized or utilizing one of the following methods of birth control throughout the trial - IUD, diaphragm, Depo-Provera, Norplant, oral contraceptive ...

Countries:United States
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