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

Inclusion Criteria2

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

Exclusion Criteria5

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