StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
Recruiting now · Phase 4
Conditions studied: Postmenopausal Osteoporosis
In brief
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 facts
- Study ID
- NCT06767150
- Run by
- University Hospital, Toulouse
- People needed
- 200
- Starts
- 2025-10-02
- Expected to finish
- 2030-10-01
- Last updated by the study team
- 2025-12-31
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Dmab use for bone disease other than post-menopausal osteoporosis.
- Uncontrolled endocrine diseases. Liver failure.
- Use of medication affecting bone metabolism during the last year, including bisphosphonates, teriparatide, romosozumab, Selective Estrogen Receptor Modulators, breast cancer hormonotherapy, glucocorticoids over 5 mg/day.
- Contra-indication to bisphosphonates according to license recommendation including chronic kidney disease with GFR stage > or = G3b. Prior intolerance to zoledronic acid.
- Subjects unable to give an informed consent or to fill the case report form. Subjects under law protection.
- Foreseeable poor compliance with the strategy, alcoholism, toxicomania.
Where it is running
- Toulouse Hospital — Toulouse, France (enrolling)
- Bordeaux Hospital — Bordeaux, France (enrolling)
- Cahors Hospital — Cahors, France (enrolling)
- Dax Hospital — Dax, France (enrolling)
- Le Mans Hospital — Le Mans, France (enrolling)
- Amiens Hospital — Amiens, France (enrolling)
- Limoges Hospital — Limoges, France (enrolling)
- Marseille Hsopital — Marseille, France (enrolling)
- Montpellier Hospital — Montpellier, France (enrolling)
- Nice Hospital — Nice, France (enrolling)
- Orléans Hospital — Orléans, France (enrolling)
- Cochin Hospital — Paris, France (enrolling)
- Lariboisiere Hospital — Paris, France (enrolling)
- Poitiers Hospital — Poitiers, France (enrolling)
- Rennes Hospital — Rennes, France (enrolling)
- Saint Etienne Hospital — Saint-Etienne, France (enrolling)
- Lille Hospital — Lille, France
Full record on ClinicalTrials.gov
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