Actively Recruiting
Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals
Led by Hadassah Medical Organization · Updated on 2025-09-18
110
Participants Needed
3
Research Sites
416 weeks
Total Duration
On this page
Sponsors
H
Hadassah Medical Organization
Lead Sponsor
S
Sheba Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over age of 18 years old of any gender, social, religious or racial background.
- Confirmed positive result for HIV infection.
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Rambam Medical Center
Haifa, Israel
Not Yet Recruiting
2
Hadassah Hebrew University Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
3
Sheba Medical Center
Ramat Gan, Israel
Not Yet Recruiting
Research Team
H
Hila Doctor Elinav, Doctor
CONTACT
A
Auryan Szalat, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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