Clinical Trial

StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis

Study acronym: SAFEST
Recruiting Phase 4
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-06.
Status change: Not Yet Recruiting → Recruiting 2025-12-23
Trial Details
NCT Number NCT06767150
Lead Sponsor University Hospital, Toulouse
Conditions Postmenopausal Osteoporosis
Enrollment 200 participants
Start Date 2025-10-02
Primary Completion 2030-10 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2025-12-31