Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals

Launched by HADASSAH MEDICAL ORGANIZATION · Jan 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called zoledronic acid can help prevent bone loss in people who have just been diagnosed with HIV and are starting treatment. When people begin antiviral therapy for HIV, they may experience a drop in bone mass, which can lead to conditions like osteopenia (weakened bones). The researchers want to find out if one dose of zoledronic acid can protect against this bone loss compared to those who receive follow-up care without the medication.

To be eligible for this study, participants must be adults over 18 years old who have a confirmed HIV infection. They will need to provide blood samples at different times and undergo bone density scans to measure their bone health before starting treatment and at several intervals afterward. Half of the participants with moderate bone loss will receive the zoledronic acid dose, while the other half will just be monitored. It's important to note that women who are pregnant or planning to become pregnant, as well as individuals with certain medical conditions, will not be able to participate in the trial. Overall, this study aims to better understand how to protect bone health in people receiving HIV treatment.

Gender

ALL

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