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RECRUITINGPhase 4INTERVENTIONAL

StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 willing to sign a consent form or to fill the case report form. Subjects under law protection. - Foreseeable poor compliance with the strategy, alcoholism, toxicomania. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

a second infusion of ZOL when crosslaps levels reach 300 pg/mL

a first infusion of ZOL 5 mg, 6 months after denosumab withdrawal (= study start) and a second infusion when crosslaps levels reach 300 pg/mL, no later than month-12

DRUG

a rescue second infusion at month-12 (standard traitment)

a first infusion of ZOL 5 mg, 6 months after denosumab withdrawal (= study start), and potentially a rescue second infusion at month-12, in case unfavourable outcome (incident osteoporotic fractures) or high risk of unfavourable outcome

Locations (17)

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