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One-Dose bone shield for HIV patients? new trial tests zoledronic acid

NCT ID NCT06762730

Prevention Sponsor: Hadassah Medical Organization 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether one dose of zoledronic acid can prevent bone loss that often happens when people start HIV medications. About 110 adults newly diagnosed with HIV and showing early bone thinning will be randomly assigned to get the drug or just follow-up. Researchers will track bone density over 48 months to see if the single dose protects bone mass.

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
What this could lead to
If it works, this could offer a simple, one-time way to protect bone health in people starting HIV therapy.
What could go wrong
This is a Phase 4 trial with only 110 participants, so results may not apply to everyone. The drug may not prevent bone loss as hoped, and side effects like jaw problems or atypical fractures are possible.

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 110 people

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

Started

Dec 2024

Expected to finish

Dec 2032

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: * Adults over age of 18 years old of any gender, social, religious or racial background. * Confirmed positive result for HIV infection. Exclusion Criteria: Patients who received previous pharmacological agents for the prevention of HIV infection. * Women who are pregnant, lactating or those who plan to become pregnant within the trial timeframe. * Past history of severe drug-induced reaction (including atypical femur fractures or osteonecrosis of the jaw) or documented hypersensitivity to a bisphosphanate agent. * Patients with untreated hypocalcemia at screening. * Severe dental status

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Conditions

The condition(s) this trial relates to.

Bone Diseases, Metabolic HIV infectious disease

As listed by the trial registrant

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

HIV-infected individuals Osteopenia

How to take part

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

  1. The places running it

    3 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

  • Hadassah Hebrew University Medical Center

    RECRUITING

    Jerusalem, 9112001, Israel

  • Rambam Medical Center

    NOT_YET_RECRUITING

    Haifa, Israel

  • Sheba Medical Center

    NOT_YET_RECRUITING

    Ramat Gan, Israel

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