Preventing bone loss in HIV positive individuals using zoledronic acid
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
This study tests if a single dose of zoledronic acid can help prevent bone loss in people who have just been diagnosed with HIV and are starting treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 3 sites (Haifa and 2 other locations) |
| Trial ID | NCT06762730 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether a single dose of zoledronic acid can prevent bone mass deterioration in treatment-naive individuals recently diagnosed with HIV. Participants will undergo blood tests and DXA scans to monitor bone health before and after starting antiviral treatment. The study compares outcomes between those receiving the medication and those who are only monitored without intervention. The goal is to determine the effectiveness of zoledronic acid in preserving bone density during HIV treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have recently been diagnosed with HIV and have not previously received treatment.
Not a fit: Patients with severe osteoporosis or those who have previously received pharmacological agents for HIV prevention may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help maintain bone health in HIV positive patients starting antiviral therapy.
How similar studies have performed: While there is ongoing research into bone health in HIV patients, the specific use of zoledronic acid in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Haifa and 2 other locations
- 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)
Study contacts
- Principal investigator: Hila Elinav, Doctor — Hadassah University Medical center
- Study coordinator: Hila Doctor Elinav, Doctor
- Email: hilaelinav@gmail.com
- Phone: +972587874340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.