Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT06767150
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06767150
Study Brief:
Protocol Section:
NCT06767150