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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised at 2 of 3 sites
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06762730
Lead Sponsor Hadassah Medical Organization
Collaborators: Sheba Medical Center, Rambam Health Care Campus
Conditions
(from sponsor)		 HIV Infected Individuals, Osteopenia
Related terms Bone Diseases, Metabolic
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov