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StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis

Study acronym: SAFEST
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Mar 2030 to Oct 2030 · Start date changed from estimate of Mar 2025 to Oct 2, 2025 · Site details revised at 17 of 17 sitesv2 Show 3 more changesShow less
    • Primary and study completion dates: Mar 2030 to Oct 2030
    • Start date changed from estimate of Mar 2025 to Oct 2, 2025
    • Site details revised at 17 of 17 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Denosumab (Dmab) is a treatment for postmenopausal osteoporosis. However, its withdrawal is associated with a rebound phenomenon associated with an unexpected increased risk of vertebral fractures. Defining the optimal strategy for Dmab withdrawal is critically needed. Investigator propose an open-label randomized superiority strategy trial to compare the 1-year lumbar densitometric efficacy of biomarkers-driven zoledronate (ZOL) infusion vs standardized ZOL treatment to mitigate rebound phenomenon.
Trial Details
NCT Number NCT06767150
Lead Sponsor University Hospital, Toulouse
Conditions Postmenopausal Osteoporosis
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov