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Clinical Trials in Israel / NCT06762730
Recruiting Phase 4

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

NCT06762730 · tracked via the Priya Life Science Israel tracker
Sponsor
Hadassah Medical Organization
Phase
Phase 4
Started
2024-12-09
Last updated
2025-09-18

Condition(s) studied

HIV Infected IndividualsOsteopenia

Investigational drug(s) / intervention(s)

Zoledronic Acid 5 mg/Bag 100 ml Inj →

Zoledronic Acid 5 mg/Bag 100 ml Inj: Zolendric acid will be provided to HIV naïve patients with documented osteopnia

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Bone density at 12 months. — 12 months of initiation of ART
    Average change (in %) from baseline in spine T score and hip T-score values among participants in the intervention group versus participants in the control group at 12 months after ART initiation

Trial sites (3)

FacilityCityRegionStatus
Rambam Medical Center Haifa Israel Not Yet Recruiting
Hadassah Hebrew University Medical Center Jerusalem Israel Recruiting
Sheba Medical Center Ramat Gan Israel Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06762730 on ClinicalTrials.gov ↗ ← All trials in Israel