StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
Recruiting · NCT06767150 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Toulouse
View the official record on ClinicalTrials.gov →Interventions studied
a rescue second infusion at month-12 (standard traitment)a second infusion of ZOL when crosslaps levels reach 300 pg/mL
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
17 locations listed.
- Amiens Hospital - Amiens, France
- Bordeaux Hospital - Bordeaux, France
- Cahors Hospital - Cahors, France
- Dax Hospital - Dax, France
- Le Mans Hospital - Le Mans, France
- Lille Hospital - Lille, France
- Limoges Hospital - Limoges, France
- Marseille Hsopital - Marseille, France
- Montpellier Hospital - Montpellier, France
- Nice Hospital - Nice, France
- Orléans Hospital - Orléans, France
- Cochin Hospital - Paris, France
- Lariboisiere Hospital - Paris, France
- Poitiers Hospital - Poitiers, France
- Rennes Hospital - Rennes, France
- Saint Etienne Hospital - Saint-Etienne, France
- Toulouse Hospital - Toulouse, France