Strategies for zoledronic acid post-denosumab discontinuation in postmenopausal osteoporosis
Key facts
- Where
- Amiens Cedex 1, Bayonne, Bordeaux, Cahors, Dax, Le Mans Cedex 9, Limoges, Marseille, Montpellier Cedex 5, Nice, Orleans Cedex 2, Paris, Paris Cedex 10, Perpignan Cedex, Poitiers, Rennes, Saint-Priest-en-Jarez, Toulouse és Toulouse Cedex 9, FranciaországSee the 19 sites
- Phase
- 4. fázis
Where in Franciaország
- Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranciaországTaking people
- Centre Hospitalier de la Cote BasqueBayonne, FranciaországTaking people
- Centre hospitalier Universitaire de BordeauxBordeaux, FranciaországTaking people
- Centre Hospitalier Jean RougierCahors, FranciaországTaking people
- Centre Hospitalier De Dax Cote D'ArgentDax, FranciaországTaking people
- Centre Hospitalier Le MansLe Mans Cedex 9, FranciaországTaking people
- Centre Hospitalier Et Universitaire de LimogesLimoges, FranciaországTaking people
- Centre Hospitalier Regional De MarseilleMarseille, FranciaországTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranciaországTaking people
- Centre Hospitalier Universitaire de NiceNice, FranciaországTaking people
- Centre Hospitalier Universitaire D OrleansOrleans Cedex 2, FranciaországTaking people
- Assistance Publique Hopitaux de ParisParis, FranciaországTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 10, FranciaországTaking people
- Centre Hospitalier De PerpignanPerpignan Cedex, FranciaországTaking people
- Universite De PoitiersPoitiers, FranciaországTaking people
- Centre Hospitalier Universitaire de RennesRennes, FranciaországTaking people
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranciaországTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranciaországTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranciaországTaking 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
- Centre Hospitalier Universitaire De Toulouse
- Trial code
- EU 2024-511871-13-00
- Record updated
- 2026. június 26.
- Original description
To compare the 1-year lumbar clinical and densitometric efficacy of biomarkers-driven ZOL treatment vs standardized ZOL treatment after denosumab withdrawal in post-menopausal osteoporosisRead full original descriptionShow less
To compare the 1-year lumbar clinical and densitometric efficacy of biomarkers-driven ZOL treatment vs standardized ZOL treatment after denosumab withdrawal in post-menopausal osteoporosis
Inclusion: Women aged ≥ 18 years; With post-menopausal osteoporosis AND treated with denosumab for at least 2 years; With post-menopausal osteoporosis - AND reaching decision of denosumab withdrawal because of achieved therapeutic target defined as no fracture during the last 2 years of treatment; no new risk factors; no BMD decrease > 0.03 g/cm² at the spine or hip; With post-menopausal osteoporosis - AND with a history of severe fracture OR a femoral or a lumbar T-score ≤ −2.5 prior denosumab initiation; Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research); Person affiliated or beneficiary of the French social security scheme.
Exclusion: Ongoing treatment with systemic glucocorticoids. However, substitutive treatment with hydrocortisone (20-30 mg/per day) is tolerated; Daily systemic glucocorticoids ≥ 7.5 mg prednisone-equivalent used for at least 3 months, and stopped less than 3 months prior inclusion; Contra-indication to bisphosphonates according to license recommendation including: o Chronic kidney disease with Glomerular filtration rate stage > or = G3b (<35 mL/min) o Prior intolerance to zoledronic acid or another bisphosphonate o Hypocalcemia; Bone disease other than post-menopausal osteoporosis, including metabolic bone disease; Uncontrolled endocrine diseases; Liver failure; Cancer not in remission for at least 5 years. Chronic asymptomatic hemopathies not requiring treatment are tolerated (e.g., asymptomatic Binet stage A chronic lymphocytic leukaemia, etc.); Use of medication affecting bone metabolism during the last year: bisphosphonates, teriparatide, romosozumab, hormone replacement therapy, selective Estrogen receptor modulators, breast cancer hormonotherapy; 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; Patients with non-healed jaw injury.