NCT06767150RecruitingPhase 4
StrAtegies For Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal oSTeoporosis
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 6 Jan 2025
- Start date
- 2 Oct 2025
- Primary completion date
- Oct 2030
- Lead sponsor
- University Hospital, Toulouse
- Diseases
- Osteoporosis
- NCT number
- NCT06767150
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 2 Oct 2025 to the primary completion date, Oct 2030
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Contra-indication to bisphosphonates according to license recommendation including chronic kidney disease with GFR stage \> or = G3b. Prior intolerance to zoledronic acid.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.