drugset / Trial / NCT06767150

StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis

NCT06767150

Phase 4 Recruiting 200 enrolled University Hospital, Toulouse
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-10-02
Primary completion
2030-10
Completion
2030-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Zoledronate Other / unclassified 5 mg