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A Randomised, Placebo-Controlled, Multi-Dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women With Low Bone Mineral Density

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Trial Profile

A Randomised, Placebo-Controlled, Multi-Dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women With Low Bone Mineral Density

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Oct 2021

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At a glance

  • Drugs Romosozumab (Primary) ; Alendronic acid; Calcium; Denosumab; Teriparatide; Vitamin D; Zoledronic acid
  • Indications Bone resorption; Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen; Astellas Pharma; UCB Pharma Inc

Most Recent Events

  • 22 Aug 2020 Results presented at the 2020 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases
  • 16 Jan 2019 According to a UCB media release, the US FDA's Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) recommended the approval of EVENITY(romosozumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, wherein eighteen of nineteen members voted positively in favour of the approval. The approval is based on results from phase 2 (20060326), FRAME, BRIDGE and ARCH studies.
  • 04 Apr 2017 Results of transitioning to zoledronic acid following romosozumab presented at The 99th Annual Meeting of the Endocrine Society

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