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StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
Sponsor: University Hospital, Toulouse
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-10-02
Completion Date
2030-10
Last Updated
2025-12-31
Healthy Volunteers
No
Conditions
Interventions
a second infusion of ZOL when crosslaps levels reach 300 pg/mL
a first infusion of ZOL 5 mg, 6 months after denosumab withdrawal (= study start) and a second infusion when crosslaps levels reach 300 pg/mL, no later than month-12
a rescue second infusion at month-12 (standard traitment)
a first infusion of ZOL 5 mg, 6 months after denosumab withdrawal (= study start), and potentially a rescue second infusion at month-12, in case unfavourable outcome (incident osteoporotic fractures) or high risk of unfavourable outcome
Locations (17)
Amiens Hospital
Amiens, France
Bordeaux Hospital
Bordeaux, France
Cahors Hospital
Cahors, France
Dax Hospital
Dax, France
Le Mans Hospital
Le Mans, France
Lille Hospital
Lille, France
Limoges Hospital
Limoges, France
Marseille Hsopital
Marseille, France
Montpellier Hospital
Montpellier, France
Nice Hospital
Nice, France
Orléans Hospital
Orléans, France
Cochin Hospital
Paris, France
Lariboisiere Hospital
Paris, France
Poitiers Hospital
Poitiers, France
Rennes Hospital
Rennes, France
Saint Etienne Hospital
Saint-Etienne, France
Toulouse Hospital
Toulouse, France