Zoledronate options after stopping denosumab in postmenopausal osteoporosis.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open‑label, randomized superiority trial comparing two approaches after denosumab discontinuation: a single standardized zoledronate infusion versus a biomarker‑guided strategy that gives an additional zoledronate infusion if serum CrossLaps rises above 300 pg/mL. Eligible participants are postmenopausal women treated with denosumab for at least two years who meet stopping criteria after reaching therapeutic targets. Participants will be followed for one year with primary outcome of lumbar spine bone mineral density change and secondary outcomes including bone turnover markers and fracture events. The biomarker arm uses scheduled CrossLaps monitoring to trigger extra treatment, while the control arm receives one infusion with a possible rescue dose at month 12.

Why it matters

Who can join: the full rules

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.

Where it's running

• Amiens Hospital
  Amiens, France Recruiting
• Bordeaux Hospital
  Bordeaux, France Recruiting
• Cahors Hospital
  Cahors, France Recruiting
• Dax Hospital
  Dax, France Recruiting
• Le Mans Hospital
  Le Mans, France Recruiting
• Limoges Hospital
  Limoges, France Recruiting

Study contacts

• Study coordinator: Yannick DEGBOE, MD
• Email: degboe.y@chu-toulouse.fr
• Phone: 05 61 77 73 75

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Romosozumab and denosumab alone or together for postmenopausal osteoporosis

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• Denosumab effects on muscle strength and insulin sensitivity

  This trial will test whether denosumab improves muscle strength and insulin sensitivity in postmenopausal women with osteoporosis and type 2 diabetes who are taking metformin.

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• Combining PD-1 immunotherapy, denosumab, and chemotherapy for advanced non-squamous lung cancer without targetable mutations

  This trial will test whether adding a PD-1 immunotherapy and denosumab to standard chemotherapy helps people with advanced non-squamous non-small cell lung cancer who do not have targetable driver mutations.

  Recruiting Phase 2 China Medical University, China · Shenyang, Liaoning · NCT07034391

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.