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A randomized, double-blind, parallel-group, active-controlled comparative study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of LY06006 compared with EU-Prolia in postmenopausal women with osteoporosis

Trial Profile

A randomized, double-blind, parallel-group, active-controlled comparative study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of LY06006 compared with EU-Prolia in postmenopausal women with osteoporosis

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 May 2024

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Luye Pharma Group; Shandong Boan Biotechnology

Most Recent Events

  • 24 Apr 2024 Status changed from recruiting to active, no longer recruiting.
  • 07 Nov 2023 Planned number of patients changed from 394 to 524.
  • 04 May 2023 According to Boan Biotech Media Release, Denosumab Injection (BA6101; BA1102) has been initiated in Europe, the United States, and Japan, and recently the first patient in (FPI) was achieved.

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