Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals
NCT ID: NCT06762730
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
110 participants
INTERVENTIONAL
2024-12-09
2032-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Zoledronic acid
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.
Zoledronic Acid 5 mg/Bag 100 ml Inj
Zolendric acid will be provided to HIV naïve patients with documented osteopnia
Follow up-comparator
Patients with T score from -1 to -2.4 that will be followed without intervention
No interventions assigned to this group
mildly osteopenic patients
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
No interventions assigned to this group
Osteoporotic patients
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
No interventions assigned to this group
Interventions
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Zoledronic Acid 5 mg/Bag 100 ml Inj
Zolendric acid will be provided to HIV naïve patients with documented osteopnia
Eligibility Criteria
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Inclusion Criteria
* Confirmed positive result for HIV infection.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Rambam Hospital, Haifa, Israel
UNKNOWN
Hadassah Medical Organization
OTHER
Responsible Party
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Hila Elinav
Professor
Principal Investigators
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Hila Elinav, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hadassah University Medical center
Eynat Kedem, Doctor
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Itzchak Levy, Proffesor
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Rambam Medical Center
Haifa, , Israel
Hadassah Hebrew University Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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012724-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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