Preventing bone loss in HIV positive individuals using zoledronic acid
Official title: 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
Run by Hadassah Medical Organization · NCT06762730 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 3 sites (Haifa and 2 other locations) |
| Status | Recruiting |
| Started | December 9, 2024 |
| Main results expected | December 1, 2028 |
| Study ends | December 1, 2032 |
| Registry record updated | September 18, 2025 |
| Trial ID | NCT06762730 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who have recently been diagnosed with HIV and have not previously received treatment.
✕Probably not a fit
Patients with severe osteoporosis or those who have previously received pharmacological agents for HIV prevention may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Hadassah Hebrew University Medical Center
Jerusalem, Israel Recruiting -
Rambam Medical Center
Haifa, Israel Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Functional Muscle-Bone Incongruity Index: A look at muscle strength and bone health in adults
This observational study tests a composite FKUI score using handgrip strength and hip/spine bone density to see if it better reflects musculoskeletal health than each measure alone in adults undergoing routine DXA.
-
Veverimer to reduce acid load and slow bone loss in adults with osteopenia
This trial will test whether taking veverimer, compared with placebo, lowers urinary acid levels and reduces bone breakdown in adults aged 50 and older with osteopenia.
-
Using REMS ultrasound to check bone density in children and teens with conditions that lower bone strength
This project will test whether REMS, a radiation-free ultrasound method, can measure bone mineral density in children and adolescents aged 5–18 who have conditions that weaken their bones.
-
Weekly everolimus and resistance training to boost bone health in postmenopausal women
This project will see if a weekly everolimus pill, resistance (strength) training, or both can improve bone formation and muscle function in postmenopausal women aged 60–75.
-
Validating lab assays, IV catheter techniques, and devices for endocrine, cardiometabolic, and musculoskeletal conditions
This project will test whether laboratory assays, IV catheter methods, and equipment give consistent, reliable results in adults with or without obesity-related, metabolic, or musculoskeletal conditions.
-
High-Intensity Interval Training for Bone Health in Older Women
This study is testing if a 24-week high-intensity workout program can help older women with low bone density feel better and improve their bone health.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.