Tests zoledronic acid to protect bone in people newly diagnosed with HIV
Tests one zoledronic acid infusion to prevent bone loss in adults newly starting HIV treatment.
Plain-language title generated from the registry record
Registry title: Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals
Key facts
- Where
- Haifa, Jerusalem, and Ramat Gan, IsraelSee the 3 sites
- Phase
- Phase 4
Where in Israel
- Rambam Medical CenterHaifa, IsraelNot yet recruiting
- Hadassah Hebrew University Medical CenterJerusalem, IsraelTaking people
- Sheba medical centerRamat Gan, IsraelNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hadassah Medical Organization
- Trial code
- NCT06762730
- Record updated
- 18 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Adults over age of 18 years old of any gender, social, religious or racial background; Confirmed positive result for HIV infection.
Exclusion: Patients who received previous pharmacological agents for the prevention of HIV infection; Past history of severe drug-induced reaction (including atypical femur fractures or osteonecrosis of the jaw) or documented hypersensitivity to a bisphosphanate agent; Women who are pregnant, lactating or those who plan to become pregnant within the trial timeframe; Patients with untreated hypocalcemia at screening; Severe dental status.