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A Multinational, Randomized, Double-Blind, Active-Controlled Phase 3 Study to Compare the Clinical Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EB1001 Biosimilar With EU-Licensed Prolia in Postmenopausal Women With Osteoporosis

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Trial Profile

A Multinational, Randomized, Double-Blind, Active-Controlled Phase 3 Study to Compare the Clinical Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EB1001 Biosimilar With EU-Licensed Prolia in Postmenopausal Women With Osteoporosis

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Sep 2023

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Eden Biologics

    • Most Recent Events

    • 14 Sep 2023 This trial has been discontinued in Bulgaria, according to European Clinical Trials Database record
    • 08 Sep 2023 Planned number of patients changed from 205 to 410.
    • 28 Aug 2023 This trial has been discontinued in Estonia, according to European Clinical Trials Database record.

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