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teriparatide 20 micrograms/day

Phase 3

Osteoporosis, Post-Menopausal | Small molecule | Endocrine |Eli Lilly and Company|Trials Updated: Oct 12, 2007

teriparatide 20 micrograms/day target and mechanism

Molecular targetPTH1R
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment237

FDA Designations

No designations recorded

teriparatide 20 micrograms/day clinical trials

teriparatide 20 micrograms/day · 3 trials · 2 indications

Phase 3 3
NCT00542984Comparison Medications in the Treatment of Postmenopausal Women With OsteoporosisOsteoporosis, Postmenopausal
COMPLETED70 Analytics
NCT00543023A Study of the Treatment of Postmenopausal Women With OsteoporosisOsteoporosis, Post-Menopausal
COMPLETED104 Analytics
NCT00543218PTH Comparison in Post Menopausal WomenOsteoporosis, Post-Menopausal
COMPLETED63 Analytics
PHASE3COMPLETED
Comparison Medications in the Treatment of Postmenopausal Women With Osteoporosis
Osteoporosis, PostmenopausalUnlock trial analytics
PHASE3COMPLETED
A Study of the Treatment of Postmenopausal Women With Osteoporosis
Osteoporosis, Post-MenopausalUnlock trial analytics
PHASE3COMPLETED
PTH Comparison in Post Menopausal Women
Osteoporosis, Post-MenopausalUnlock trial analytics

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.
to compare the effect of treatment with teriparatide 20 micrograms/day subcutaneous with that of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD in postmenopausal women with established osteoporosis.

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 -
calcitonin 100 IU/day subcutaneousDRUG -
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Eligibility Criteria

Age Range55 Years to 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 KoreaChinaTaiwan
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Frequently asked questions about teriparatide 20 micrograms/day

What is teriparatide 20 micrograms/day used for?

Teriparatide 20 micrograms/day is used to treat osteoporosis in postmenopausal women. It is given as a subcutaneous injection and is studied in Phase 3 clinical trials for postmenopausal osteoporosis. The trials enrolled postmenopausal women aged 55 years and older.

What does teriparatide 20 micrograms/day target?

Teriparatide 20 micrograms/day targets PTH1R, the parathyroid hormone 1 receptor, where it acts as an agonist. By activating this receptor, the drug stimulates bone formation. This mechanism underlies its use in treating postmenopausal osteoporosis.

Who makes teriparatide 20 micrograms/day?

Teriparatide 20 micrograms/day is developed by Eli Lilly and Company, which trades under the ticker LLY. Eli Lilly is the sponsor behind the clinical development program for this osteoporosis therapy.

What phase is teriparatide 20 micrograms/day in?

Teriparatide 20 micrograms/day is in Phase 3 clinical development for postmenopausal osteoporosis. It is an investigational therapy, and the completed Phase 3 trials evaluated it in postmenopausal women with osteoporosis.

What clinical trials is teriparatide 20 micrograms/day in?

Teriparatide 20 micrograms/day has been studied in Phase 3 trials including NCT00543218 in Taiwan, NCT00543023 in China, and NCT00542984 in South Korea. All three trials are completed and enrolled postmenopausal women aged 55 years and older with osteoporosis.