Zoledronic acid timing after stopping denosumab in postmenopausal osteoporosis
Tests when to give a second zoledronic acid infusion after stopping denosumab in postmenopausal women.
Plain-language title generated from the registry record
Registry title: StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
Key facts
- Where
- Amiens, Bordeaux, Cahors, Dax, Le Mans, Lille, Limoges, Marseille, Montpellier, Nice, Orléans, Paris, Poitiers, Rennes, Saint-Etienne, and Toulouse, FranceSee the 17 sites
- Phase
- Phase 4
Where in France
- Amiens hospitalAmiens, FranceTaking people
- Bordeaux HospitalBordeaux, FranceTaking people
- Cahors HospitalCahors, FranceTaking people
- Dax HospitalDax, FranceTaking people
- Le Mans HospitalLe Mans, FranceTaking people
- Lille HospitalLille, FranceNot yet recruiting
- Limoges HospitalLimoges, FranceTaking people
- Marseille HsopitalMarseille, FranceTaking people
- Montpellier HospitalMontpellier, FranceTaking people
- Nice HospitalNice, FranceTaking people
- Orléans HospitalOrléans, FranceTaking people
- Cochin HospitalParis, FranceTaking people
- Lariboisière HospitalParis, FranceTaking people
- Poitiers HospitalPoitiers, FranceTaking people
- Rennes HospitalRennes, FranceTaking people
- Saint-etienne hospitalSaint-Etienne, FranceTaking people
- Toulouse HospitalToulouse, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Toulouse
- Trial code
- NCT06767150
- Record updated
- 31 December 2025
- Original description
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.Read full original descriptionShow less
StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
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.
Inclusion: 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.
Exclusion: 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.