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Can a tailored infusion schedule prevent fractures after stopping denosumab?

NCT ID NCT06767150

Disease control Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at women with postmenopausal osteoporosis who have been on denosumab for at least two years and are now stopping it. Stopping denosumab can cause a rapid bone loss and increase fracture risk. The trial compares two strategies using zoledronic acid infusions: one where the second infusion is given based on a blood test (crosslaps levels), and another where it is given at a fixed time. The goal is to see which approach better maintains bone density after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zoledronic acid (ZOL)
What this could lead to
If successful, this could provide a safer way to stop denosumab without losing bone density or increasing fracture risk.
What could go wrong
This is a small, early-phase trial with only 200 participants, so results may not apply to everyone. The personalized approach may not outperform standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

postmenopausal osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postmenopausal osteoporosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amiens Hospital

    RECRUITING

    Amiens, France

  • Bordeaux Hospital

    RECRUITING

    Bordeaux, France

  • Cahors Hospital

    RECRUITING

    Cahors, France

  • Cochin Hospital

    RECRUITING

    Paris, France

  • Dax Hospital

    RECRUITING

    Dax, France

  • Lariboisiere Hospital

    RECRUITING

    Paris, France

  • Le Mans Hospital

    RECRUITING

    Le Mans, France

  • Lille Hospital

    NOT_YET_RECRUITING

    Lille, France

  • Limoges Hospital

    RECRUITING

    Limoges, France

  • Marseille Hsopital

    RECRUITING

    Marseille, France

  • Montpellier Hospital

    RECRUITING

    Montpellier, France

  • Nice Hospital

    RECRUITING

    Nice, France

  • Orléans Hospital

    RECRUITING

    Orléans, France

  • Poitiers Hospital

    RECRUITING

    Poitiers, France

  • Rennes Hospital

    RECRUITING

    Rennes, France

  • Saint Etienne Hospital

    RECRUITING

    Saint-Etienne, France

  • Toulouse Hospital

    RECRUITING

    Toulouse, France

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