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RECRUITING
NCT06767150
PHASE4

StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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