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Can a single dose of zoledronic acid safely treat bone loss in dialysis patients?

NCT ID NCT07741136

Disease control Sponsor: University of Campinas, Brazil Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This trial investigates how the drug zoledronic acid is processed in the body of people with chronic kidney disease who are on dialysis and also have osteoporosis. It aims to find the best dose—either 2.5 mg or 5 mg—given as a single intravenous injection during a dialysis session. Researchers will measure drug levels in blood and dialysis fluid to understand how much is removed by dialysis and how the drug affects bone health over 12 months. The study includes 24 adults: 16 on dialysis and 8 with milder kidney disease as a comparison group.

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 (an intravenous bisphosphonate drug given as a single dose)
What this could lead to
If successful, this could establish a safe and effective dosing strategy for zoledronic acid in dialysis patients, potentially reducing fractures and improving quality of life in this high-risk group.
What could go wrong
This is a small, early-phase study focused on drug levels, not long-term outcomes. The drug may behave differently in dialysis patients, and there are risks like low calcium or phosphate levels, which the trial carefully monitors.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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

Anyone

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: * Individuals aged 18 years or older, with CKD-associated osteoporosis * eGFR ≥ 35 mL/min/1.73 m2 and advanced CKD on dialysis * Agree to participate in the research by signing the informed consent form Exclusion Criteria: * Individuals under 18 years of age, pregnant or breastfeeding women * Patients with CKD with hypocalcemia/hypophsphatemia * Patients with CKD on dialysis with residual diuresis \> 100 mL/24h\* * Patients with CKD on low-flux membrane dialysis\* * Patients with neoplasia * Hypersensitivity to bisphosphonates, or previous use of the medication * Inadequate oral condition or anticipated invasive dental procedure within the next 12 months * Alkaline phosphatase \< 98 IU/L or \> 180 IU/L\* * PTH \< 130 pg/mL and \> 585 pg/mL\* * CTX \< Lower Limit of Normal (LLN) or * CTX \< Upper Reference Limit (URL)\* * Severe liver disease * Severe heart disease * Clinical suspiction of osteomalacia or adynamic bone disease * Cytopenias, defined as: platelets \< 120,000/mm³, neutrophils \< 3,000/mm³, lymphocytes \< 1,000/mm³ and hematocrit \< 26% \* Applicable only to the group of patients undergoing dialysis.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome osteoporosis renal osteodystrophy

As listed by the trial registrant

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

Chronic kidney disease Dialysis Osteoporosis

How to take part

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

  1. The places running it

    1 site. 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

  • School of Medical Sciences, University of Campinas

    Campinas, São Paulo, 13083-887, Brazil

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