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Clinical trial

A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia® in Postmenopausal Women With Osteoporosis

NCT04664959 is registered in ClinicalTrials.gov with Samsung Bioepis Co., Ltd. as lead sponsor.

NCT NCT04664959
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia® in Postmenopausal Women With Osteoporosis
Lead sponsor
Samsung Bioepis Co., Ltd.
Phase
Phase 3
Overall status
Completed
Start date
November 26, 2020
Completion date
January 3, 2023
Enrollment
457 (actual)
Sites
5

Conditions

As the registry lists them; a condition with its own page is linked.

postmenopausal osteoporosis