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
Sponsor study identifier
interventional
110
1 country
3
Study Start
December 9, 2024
Actual (reported)Primary Completion
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 9, 2024
Actual (reported)December 31, 2024
Actual (reported)January 8, 2025
Actual (reported)December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Bone density at 12 months.
Average change (in %) from baseline in spine T score and hip T-score values among participants in the intervention group versus participants in the control group at 12 months after ART initiation
12 months of initiation of ART
Bone density at 24 months.
24 months
Bone density at 48 months.
48 months of initiation of ART
Bone fractures at 48 months
48 months of initiation of ART
Bone markers differences during folloe up
6,12,24,48 months after treatment intiation
BMD decline in TDF sparing ART
48 months of initiation of ART
Patients with T score from -1 to -2.4 will be treated with 1 dose of 5 mg of Zoledronic acid within a month of ART intiation.
Patients with T score from -1 to -2.4 that will be followed without intervention
patients with T score more than -1 will be followed only after antiviral treatment initiation- P1NP and CTX levels and DXA up to 4 years
Zolendric acid will be provided to HIV naïve patients with documented osteopnia
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rambam Medical Center
Haifa, Israel
Hadassah Hebrew University Medical Center
Jerusalem, 9112001, Israel
Hila Elinav, Doctor
Hadassah University Medical center
Eynat Kedem, Doctor
Rambam Health Care Campus
Itzchak Levy, Proffesor
Sheba Medical Center
First Submitted
December 31, 2024
First Posted
January 8, 2025
Study Start
December 9, 2024
Actual (reported)Primary Completion
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
patients with T score less than -2.5 will be treated according to standard of care with oral biphosphonates, and will be followed after antiviral treatment intiation- P1NP + CTX and DXA up to 4 years
Contact the study team to confirm eligibility.
Sheba Medical Center
Ramat Gan, Israel
Study Completion
December 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 18, 2025
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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