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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

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: 19 Nov 2020

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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

    • 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
    • 24 May 2019 Results of non-vertebral facture risk reduction upto 10 years by using data from this study and its extension study published in the Journal of Clinical Endocrinology and Metabolism.
    • 13 Feb 2019 Results assessing the rate of osteonecrosis of the jaw (ONJ) were published in the Journal of Clinical Endocrinology and Metabolism
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