StrAtegies for Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal OSTeoporosis

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

March 31, 2030

Study Completion Date

March 31, 2030

Conditions
Postmenopausal Osteoporosis
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

Trial Locations (17)

Unknown

Amiens Hospital, Amiens

Bordeaux Hospital, Bordeaux

Cahors Hospital, Cahors

Dax Hospital, Dax

Le Mans Hospital, Le Mans

Lille Hospital, Lille

Limoges Hospital, Limoges

Marseille Hsopital, Marseille

Montpellier Hospital, Montpellier

Nice Hospital, Nice

Orléans Hospital, Orléans

Cochin Hospital, Paris

Lariboisiere Hospital, Paris

Poitiers Hospital, Poitiers

Rennes Hospital, Rennes

Saint Etienne Hospital, Saint-Etienne

Toulouse Hospital, Toulouse

All Listed Sponsors
lead

University Hospital, Toulouse

OTHER