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Strategies for zoledronic acid post-denosumab discontinuation in postmenopausal osteoporosis
EU CTIS ID: 2024-511871-13-00
What this study is testing
To compare the 1-year lumbar clinical and densitometric efficacy of biomarkers-driven ZOL treatment vs standardized ZOL treatment after denosumab withdrawal in post-menopausal osteoporosis
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women aged ≥ 18 years
- With post-menopausal osteoporosis AND treated with denosumab for at least 2 years
- With post-menopausal osteoporosis - AND reaching decision of denosumab withdrawal because of achieved therapeutic target defined as no fracture during the last 2 years of treatment; no new risk factors; no BMD decrease > 0.03 g/cm² at the spine or hip
- With post-menopausal osteoporosis - AND with a history of severe fracture OR a femoral or a lumbar T-score ≤ −2.5 prior denosumab initiation.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
- Person affiliated or beneficiary of the French social security scheme.
You likely can't join if
- Bone disease other than post-menopausal osteoporosis, including metabolic bone disease
- 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.
- Uncontrolled endocrine diseases
- Liver failure
See the full eligibility criteria
- Women aged ≥ 18 years
- With post-menopausal osteoporosis AND treated with denosumab for at least 2 years
- With post-menopausal osteoporosis - AND reaching decision of denosumab withdrawal because of achieved therapeutic target defined as no fracture during the last 2 years of treatment; no new risk factors; no BMD decrease > 0.03 g/cm² at the spine or hip
- With post-menopausal osteoporosis - AND with a history of severe fracture OR a femoral or a lumbar T-score ≤ −2.5 prior denosumab initiation.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
- Person affiliated or beneficiary of the French social security scheme.
- Bone disease other than post-menopausal osteoporosis, including metabolic bone disease
- 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.
- Uncontrolled endocrine diseases
- Liver failure
- Cancer not in remission for at least 5 years. Chronic asymptomatic hemopathies not requiring treatment are tolerated (e.g., asymptomatic Binet stage A chronic lymphocytic leukaemia, etc.)
- Patients with non-healed jaw injury
- Ongoing treatment with systemic glucocorticoids. However, substitutive treatment with hydrocortisone (20-30 mg/per day) is tolerated.
- Daily systemic glucocorticoids ≥ 7.5 mg prednisone-equivalent used for at least 3 months, and stopped less than 3 months prior inclusion.
- Use of medication affecting bone metabolism during the last year: bisphosphonates, teriparatide, romosozumab, hormone replacement therapy, selective Estrogen receptor modulators, breast cancer hormonotherapy
- Contra-indication to bisphosphonates according to license recommendation including: o Chronic kidney disease with Glomerular filtration rate stage > or = G3b (<35 mL/min) o Prior intolerance to zoledronic acid or another bisphosphonate o Hypocalcemia
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.