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To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI

Trial Profile

To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 12 Sep 2023

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At a glance

  • Drugs Denosumab (Primary) ; Calcium; Vitamin D
  • Indications Osteogenesis imperfecta
  • Focus Registrational; Therapeutic Use
  • Acronyms OI
  • Sponsors Amgen
  • Most Recent Events

    • 28 Dec 2022 Status changed from completed to discontinued.
    • 15 May 2022 This trial has been completed in Spain, according to European Clinical Trials Database record.
    • 13 May 2022 This trial has been discontinued in Poland, according to European Clinical Trials Database record.

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