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An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis

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Trial Profile

An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2023

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis; Vertebral fracture
  • Focus Adverse reactions
  • Acronyms FREEDOM extension
  • Sponsors Amgen

Most Recent Events

  • 01 May 2022 Results published in the Journal of Bone and Mineral Research
  • 26 Mar 2022 Results of retrospective analysis appling updated built in tissue thickness-adjusted TBS algorithm to investigate the long-term effect of denosumab on bone microarchitecture in FREEDOM and OLE in patients who completed the FREEDOM DXA substudy , presented at the 2022 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases
  • 19 Nov 2020 Results of post hoc analysis evaluating the long-term safety and efficacy of denosumab in subjects with mild-to-moderate CKD published in the Journal of Clinical Endocrinology and Metabolism

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