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

Recruiting now · Phase 4

Conditions studied: HIV Infected Individuals, Osteopenia

In brief

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.

Key facts

Study ID

NCT06762730

Run by

Hadassah Medical Organization

People needed

110

Starts

2024-12-09

Expected to finish

2032-12-01

Last updated by the study team

2025-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults over age of 18 years old of any gender, social, religious or racial background.
• Confirmed positive result for HIV infection.

You may not qualify if…

• 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

Where it is running

• Hadassah Hebrew University Medical Center — Jerusalem, Israel (enrolling)
• Rambam Medical Center — Haifa, Israel
• Sheba Medical Center — Ramat Gan, Israel

Full record on ClinicalTrials.gov

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