A Phase 4 interventional study of Zoledronic Acid 5 mg/Bag 100 ml Inj in HIV Infected Individuals and Osteopenia, sponsored by Hadassah Medical Organization. Recruiting at 3 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Hadassah Medical Organization · Phase 4, Interventional, and Treatment
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:
Researchers will compare one dose of zolendric acid to follow-up only
Participant will:
470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.
This study's planned enrollment of 110 is above the median of 60 across 359 interventional studies indexed under Bone Diseases, Metabolic.
Browse Bone Diseases, Metabolic studies →Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who received previous pharmacological agents for the prevention of HIV infection.
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.
Drug: Zoledronic Acid 5 mg/Bag 100 ml Inj
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
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
Zolendric acid will be provided to HIV naïve patients with documented osteopnia
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
Time frame: 12 months of initiation of ART
Bone density at 24 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 24. ART.
Time frame: 24 months
Bone density at 48 months.
Average change (in %) from baseline in spine- and hip T-score values among participants in the intervention group versus participants in the control group at 48 months of initiation of ART.
Time frame: 48 months of initiation of ART
Bone fractures at 48 months
To estimate the rates of clinical fractures among all participants over a minimum of 48 months and the difference, if any, between treatment arms.
Time frame: 48 months of initiation of ART
Bone markers differences during folloe up
Identify difference in average blood levels of bone turnover markers between treatment arm and the non intervention arm during the follow-up period.
Time frame: 6,12,24,48 months after treatment intiation
BMD decline in TDF sparing ART
Rates of BMD decline (by means of rate of naïve PLHIV with baseline T score \> -1.0 who will turn to T score \<-1.0) in PLHIV treated with TDF-sparing ART over a period of 48 months.
Time frame: 48 months of initiation of ART
Plan to share: Undecided
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Hadassah Medical Organization