NCT06762730 Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals
| NCT ID | NCT06762730 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hadassah Medical Organization |
| Condition | HIV Infected Individuals |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 110 participants in total. It began in 2024-12-09 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Hila Elinav, Doctor
PRINCIPAL INVESTIGATOR
Hadassah University Medical center
Frequently Asked Questions
Who can join the NCT06762730 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Infected Individuals. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06762730 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06762730 currently recruiting?
Yes, NCT06762730 is actively recruiting participants. Contact the research team at hilaelinav@gmail.com for enrollment information.
Where is the NCT06762730 trial being conducted?
This trial is being conducted at Haifa, Israel, Jerusalem, Israel, Ramat Gan, Israel.
Who is sponsoring the NCT06762730 clinical trial?
NCT06762730 is sponsored by Hadassah Medical Organization. The principal investigator is Hila Elinav, Doctor at Hadassah University Medical center. The trial plans to enroll 110 participants.
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