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Can a single infusion lock in bone gains after osteoporosis treatment?

NCT ID NCT05575167

Disease control Sponsor: 424 General Military Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial investigates whether a single or repeat infusion of zoledronate, or daily oral alendronate, can maintain the bone density improvements achieved with denosumab in postmenopausal women with osteoporosis. Participants who have been on denosumab for at least three years will receive one of the two drugs and be followed for 24 months. The goal is to find the most effective way to prevent bone loss after stopping denosumab.

What this could mean

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

Active substance
zoledronate or alendronate, given as an infusion or oral tablet
What this could lead to
If successful, this could identify the best way to preserve bone density after stopping denosumab, reducing fracture risk in women with osteoporosis.
What could go wrong
This is a mid-stage trial, so results may not apply to all patients. Both drugs carry risks like kidney issues or jaw problems, and the best consolidation strategy is still unknown.

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.

Participants

122 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Nov 2027

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.

Who is studied

Postmenopausal women treated with denosumab

Ages

50 to 85 years

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: • Postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia Exclusion Criteria: * a bone disease other than postmenopausal osteoporosis * use of medications other than bisphosphonates or SERMS affecting bone metabolism during the last 12 months before entering the study * creatinine clearance \<60 mL/min/1.73 m2 * liver failure * any type of cancer * uncontrolled endocrine diseases * serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng/mL (50 nmol/L)

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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.

Osteoporosis postmenopausal

Contacts and locations

Locations

  • , KAT General Hospital

    Athens, 14561, Greece

  • 251 Hellenic Airforce and VA General Hospital

    Athens, 11525, Greece

  • 424 General Military Hospital

    Thessaloniki, 56429, Greece

  • Campus Bio-Medico University

    Roma, 00128, Italy

  • Department of Medicine, Surgery and Neurosciences, University of Siena

    Siena, 53100, Italy

  • First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens

    Athens, 11527, Greece

  • Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico

    Milan, Italy

  • Univ. Lille, CHU Lille

    Lille, France

  • University-Hospital S. Maria della Misericordia

    Udine, Italy

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