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A Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

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Trial Profile

A Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Nov 2024

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Osteoporosis
  • Focus Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors Celltrion; Celltrion - Nan Fung Group (JV)

    • Most Recent Events

    • 18 Nov 2024 According to a Celltrion Media Release,company published data of this trial at the American College of Rheumatology (ACR) Convergence 2024 in Washington, D.C.
    • 01 Nov 2024 Results assessing equivalence of CT-P41, a biosimilar to denosumab and the denosumab in postmenopausal women with osteoporosis were published in the Osteoporosis International
    • 17 Feb 2024 Status changed from active, no longer recruiting to completed.

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