Recent Updates
Recently added Catalysts

FORTEO

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

FORTEO · 1 trial · 2 indications

Phase 1 1
NCT00277706Impact of Parathyroid Hormone (PTH) on Osseous CavityBone Loss
COMPLETED40 Analytics
PHASE1COMPLETED
Impact of Parathyroid Hormone (PTH) on Osseous Cavity
Bone LossUnlock trial analytics

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.
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range30 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about FORTEO

What is FORTEO used for?

FORTEO is used for bone loss. It is being investigated for its effects on bone loss and periodontitis, a condition involving inflammation and infection of the gums that can damage the bone supporting teeth. The drug is being studied in a clinical trial for these conditions.

What does FORTEO target?

FORTEO targets the parathyroid hormone (PTH) pathway. It is a small molecule designed to impact osseous cavities, which are spaces within bone. The drug's mechanism involves modulating PTH activity to influence bone remodeling and potentially counteract bone loss.

Who makes FORTEO?

FORTEO is developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research to evaluate the drug's safety and efficacy for bone-related conditions.

What phase is FORTEO in?

FORTEO is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.

What clinical trials is FORTEO in?

FORTEO has one completed Phase 1 clinical trial with the identifier NCT00277706. The trial, titled 'Impact of Parathyroid Hormone (PTH) on Osseous Cavity,' enrolled 40 participants in the United States. It was a randomized, double-blind, placebo-controlled study involving adults aged 30 years and older.

Is FORTEO the same as teriparatide?

FORTEO is the brand name for teriparatide, a recombinant form of parathyroid hormone. The drug is being studied for its effects on bone loss and periodontitis. It is administered as a small molecule and is currently in Phase 1 clinical trials.