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StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis

RecruitingPhase 4Ages 18 Years - anyFemaleUniversity Hospital, Toulouse
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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/cmยฒ at the spine or hip; * And with a history of severe fracture or a femoral or lumbar T-score โ‰ค -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.
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What it tests

  • a second infusion of ZOL when crosslaps levels reach 300 pg/mL
  • a rescue second infusion at month-12 (standard traitment)
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Where

17 sites
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

โ€ฆand 9 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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