NCT06767150 StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
| NCT ID | NCT06767150 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Toulouse |
| Condition | Postmenopausal Osteoporosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-10-02 |
| Primary Completion | 2030-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2025-10-02 with a primary completion date of 2030-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06767150 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postmenopausal Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06767150 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06767150 currently recruiting?
Yes, NCT06767150 is actively recruiting participants. Contact the research team at degboe.y@chu-toulouse.fr for enrollment information.
Where is the NCT06767150 trial being conducted?
This trial is being conducted at Amiens, France, Bordeaux, France, Cahors, France, Dax, France and 11 additional locations.
Who is sponsoring the NCT06767150 clinical trial?
NCT06767150 is sponsored by University Hospital, Toulouse. The trial plans to enroll 200 participants.