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Clinical trial

A Randomized, Double-blind, Multicenter Integrated Phase I/III Study in Postmenopausal Women With Osteoporosis to Compare the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety and Immunogenicity of GP2411 (Proposed Biosimilar Denosumab) and Prolia® (EU-authorized)

NCT03974100 is registered in ClinicalTrials.gov with Sandoz as lead sponsor.

NCT NCT03974100
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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Double-blind, Multicenter Integrated Phase I/III Study in Postmenopausal Women With Osteoporosis to Compare the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety and Immunogenicity of GP2411 (Proposed Biosimilar Denosumab) and Prolia® (EU-authorized)
Lead sponsor
Sandoz
Phase
Phase 3
Overall status
Completed
Start date
July 2, 2019
Completion date
April 22, 2022
Enrollment
527 (actual)
Sites
42

Conditions

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

postmenopausal women with osteoporosis