StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Women with post-menopausal osteoporosis
• And treated with denosumab for at least 2 years and reaching decision of denosumab withdrawal because of achieved therapeutic target defined as no fracture during treatment; no new risk factors; no BMD decrease \> 0.03 g/cm² at the spine or hip;
• And with a history of severe fracture or a femoral or lumbar T-score ≤ -2.5 prior denosumab initiation.
Locations
Other Locations
France
Amiens Hospital
RECRUITING
Amiens
Bordeaux Hospital
RECRUITING
Bordeaux
Cahors Hospital
RECRUITING
Cahors
Dax Hospital
RECRUITING
Dax
Le Mans Hospital
RECRUITING
Le Mans
Lille Hospital
NOT_YET_RECRUITING
Lille
Limoges Hospital
RECRUITING
Limoges
Marseille Hsopital
RECRUITING
Marseille
Montpellier Hospital
RECRUITING
Montpellier
Nice Hospital
RECRUITING
Nice
Orléans Hospital
RECRUITING
Orléans
Cochin Hospital
RECRUITING
Paris
Lariboisiere Hospital
RECRUITING
Paris
Poitiers Hospital
RECRUITING
Poitiers
Rennes Hospital
RECRUITING
Rennes
Saint Etienne Hospital
RECRUITING
Saint-etienne
Toulouse Hospital
RECRUITING
Toulouse
Contact Information
Primary
Yannick DEGBOE, MD
degboe.y@chu-toulouse.fr
05 61 77 73 75
Backup
Charline DAGUZAN
daguzan.c@chu-toulouse.fr
05 61 77 84 90
Time Frame
Start Date:2025-10-02
Estimated Completion Date:2030-10
Participants
Target number of participants:200
Treatments
Experimental: Intensive biomarkers-guided arm
A second infusion when crosslaps levels reach 300 pg/mL, no later than month-12
Active_comparator: Standard treatment arm
Potentially a rescue second infusion at month-12, in case unfavourable outcome (incident osteoporotic fractures) or high risk of unfavourable outcome