StrAtegies for Zoledronic Acid Post-dEnosumab Discontinuation in Postmenopausal OSTeoporosis

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Jan 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best way to manage the withdrawal of denosumab, a medication used to treat postmenopausal osteoporosis, which is a condition that weakens bones in women after menopause. When patients stop taking denosumab, there can be a risk of fractures, particularly in the spine. The researchers want to compare two different approaches for giving another medication called zoledronic acid after stopping denosumab to see which method helps protect against these fractures better.

To participate in this trial, women aged 65 to 74 who have been treated with denosumab for at least two years and have no new fractures during treatment may be eligible. They should also have a history of severe fractures or poor bone density before starting denosumab. Participants will receive one of the two treatments and will be monitored for a year to see how well their bone density responds. It’s important to note that this study is not yet recruiting participants, and there are specific health criteria that could disqualify potential participants, such as certain medical conditions or a history of intolerance to zoledronic acid.

Gender

FEMALE

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.