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Open label, randomized clinical trial of zoledronic acid (Aclasta) versus vitamin D plus calcium in children and adolescents with Duchenne muscular dystrophy, to assess change in lumbar spine bone density over 12 months

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Trial Profile

Open label, randomized clinical trial of zoledronic acid (Aclasta) versus vitamin D plus calcium in children and adolescents with Duchenne muscular dystrophy, to assess change in lumbar spine bone density over 12 months

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 May 2021

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At a glance

  • Drugs Zoledronic acid (Primary) ; Calcium; Vitamin D
  • Indications Corticosteroid-induced osteoporosis
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 06 May 2021 Primary endpoint has been met. (Lumbar spine bone mineral density (Change in lumbar spine (LS) areal bone mineral density (aBMD) Z-score as assessed by dual Xray absorptiometry (DEXA), with volumetric calculation for each subject to account for size variability), as per Results published in the Journal of Clinical Endocrinology and Metabolism
  • 06 May 2021 Results published in the Journal of Clinical Endocrinology and Metabolism
  • 05 Dec 2019 Status changed from recruiting to completed.

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