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A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Trial Profile

A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2022

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At a glance

  • Drugs Romosozumab (Primary) ; Alendronic acid
  • Indications Fracture; Postmenopausal osteoporosis; Vertebral fracture
  • Focus Registrational; Therapeutic Use
  • Acronyms ARCH
  • Sponsors Amgen
  • Most Recent Events

    • 01 Aug 2022 Results of post-hoc analysis of two studies (FRAME and ARCH) assessing efficacy and safety of romosozumab in postmenopausal women with osteoporosis and mild-to-moderate chronic kidney disease, published in the Journal of Bone and Mineral
    • 26 Mar 2022 Results of post hoc analysis assessing safety in patients who experienced an on study by using data from two studies (FRAME and ARCH) clinical fracture presented at the 2022 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases
    • 26 Mar 2022 Results of post-hoc analysis of two studies (FRAME (NCT01575834) and ARCH (NCT01631214)) assessing the percentage of patients achieving the established FNIH STE thresholds, presented at the 2022 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases.
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