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Phase 3 18-month randomized, double-blind, multicenter study of PTH (1-34, teriparatide) EB613 vs. placebo in post-menopausal women with osteoporosis at high risk of fracture

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Trial Profile

Phase 3 18-month randomized, double-blind, multicenter study of PTH (1-34, teriparatide) EB613 vs. placebo in post-menopausal women with osteoporosis at high risk of fracture

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Mar 2024

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At a glance

  • Drugs Teriparatide (Primary) ; Alendronic acid
  • Indications Postmenopausal osteoporosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Entera Bio

Most Recent Events

  • 26 Mar 2024 According to an Entera Bio media release, the American Society for Bone and Mineral Research (ASBMR) announced on March 25 2024 that the U.S. Food and Drug Administration (FDA) has communicated to the SABRE (Study to Advance BMD as a Regulatory Endpoint) project team that a ruling to qualify the treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs would be provided within 10 months.
  • 08 Mar 2024 According to an Entera Bio media release, an update on the qualification process of SABRE and BMD as the surrogate endpoint for fracture is expected in 2024. This is the final de-risking event from a regulatory standpoint to move EB613 to Phase 3.
  • 08 Mar 2024 According to an Entera Bio media release, the company looks forward to initiate this pivotal phase 3 study once the final qualification of the SABRE endpoint is announced by FDA.

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