RecruitingPhase 4NCT06762730

Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals

A Single Dose Intravenous Administration of Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals - a Prospective, Multicenter, Open-label, Randomized Control Trial

Sponsor

Hadassah Medical Organization

Enrollment

110 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

Osteopenia HIV Infected Individuals

Summary

The goal of this clinical trial is to learn if zolendric acid can prevent the anticipated deterioration of bone mass after antiviral treatment initiation for people that were recently diagnosed with HIV. The main questions it aims to answer are: 1. Is bone mass deterioration is significant even with the new medication currently used to treat HIV? 2. Can one dose of Zolendric acid protect from deterioration of bone mass. Researchers will compare one dose of zolendric acid to follow-up only Participant will: 1. Provide blood samples for bone markers before antiviral treatment initiation and at 6M,12M,24M and 48M after treatment initiation 2. Perform DXA scan soon after antiviral treatment initiation and after 12M ,24 M and 48 months 3. Half of the patients with moderate reduction in bone mass will be treated with one dose of zolendric acid in the clinical trial, the other participants will be followed without intervention. 4. Patients with substantial osteoporosis will be treated according to standard of care by their HMO, but will continue followup in the study.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a single infusion of zoledronic acid (a drug usually used for osteoporosis) can prevent bone density loss in people with HIV who are starting antiretroviral therapy (ART) that does not include the drug tenofovir disoproxil fumarate (TDF). Some newer HIV regimens avoid TDF but may still affect bone health. **You may be eligible if...** - You are 18 or older with a confirmed HIV diagnosis - You have not previously taken HIV medications (treatment-naive) **You may NOT be eligible if...** - You have previously taken any HIV medication (including PrEP for prevention) - You are pregnant, breastfeeding, or plan to become pregnant during the study - You have had a serious reaction to a bisphosphonate drug (like osteonecrosis of the jaw or unusual fractures) - You have untreated low calcium levels at the time of screening - You have significant dental problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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