HIV Infected IndividualsPhase 4NCT06762730
Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals
A Phase 4 study testing Zoledronic Acid 5 mg/Bag 100 ml Inj in people with HIV Infected Individuals and Osteopenia, run by Hadassah Medical Organization at 3 sites in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infected Individuals, Osteopenia
- What is being tested?
- Zoledronic Acid 5 mg/Bag 100 ml Inj
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesIsrael
- Study dates
- 9 Dec 2024to 1 Dec 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over age of 18 years old of any gender, social, religious or racial background.
- Confirmed positive result for HIV infection.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel3 sites, 3 recruiting
- Not yet recruiting
Rambam Medical Center
Haifa
Eynat Kedem, Doctor, 972536283187, e_kedem@rambam.health.gov.il
Eynat Kedem, Doctor
- Recruiting
Hadassah Hebrew University Medical Center
Jerusalem, 9112001
Hila Elinav, Doctor, +972587874340, hilaelinav@gmail.com
Daniella Iluz, 972504048807, danielaI@hadassah.org.il
- Not yet recruiting
Sheba Medical Center
Ramat Gan
Itzchak Levy, Preoffesor, 972526667525, itsik.levi@sheba.health.gov.il
Itzchak Levy, Proffesor
About this study
Official title: 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
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:
Read more
- Is bone mass deterioration is significant even with the new medication currently used to treat HIV?
- 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:
- Provide blood samples for bone markers before antiviral treatment initiation and at 6M,12M,24M and 48M after treatment initiation
- Perform DXA scan soon after antiviral treatment initiation and after 12M ,24 M and 48 months
- 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.
- Patients with substantial osteoporosis will be treated according to standard of care by their HMO, but will continue followup in the study.
- Conditions
- HIV Infected Individuals, Osteopenia
- Being tested
- Zoledronic Acid 5 mg/Bag 100 ml Inj
- Keywords
- Osteopenia, zoledronic acid, HIV naïve
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic Acid 5 mg/Bag 100 ml InjDrug
Zolendric acid will be provided to HIV naïve patients with documented osteopnia
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic acid | Experimental | 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. Receives: Drug: Zoledronic Acid 5 mg/Bag 100 ml Inj |
| Follow up-comparator | No intervention | Patients with T score from -1 to -2.4 that will be followed without intervention |
| mildly osteopenic patients | No 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 |
| Osteoporotic patients | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months of initiation of ART
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 48 months of initiation of ART
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start9 Dec 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Infected IndividualsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center, Rambam Health Care Campus
- Responsible party
- Principal investigator, Hila Elinav, Hadassah Medical Organization
- Investigators
- Hila Elinav, Doctor, Principal investigator, Hadassah University Medical centerEynat Kedem, Doctor, Principal investigator, Rambam Health Care CampusItzchak Levy, Proffesor, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762730
- Sponsor's protocol ID
- 012724-HMO-CTIL
- Status last verified
- Dec 2024
- First submitted
- 31 Dec 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06762730
- Acronym / sponsor ID
- 012724-HMO-CTIL
- Conditions
- HIV Infected Individuals, Osteopenia
- Keywords
- Osteopenia, zoledronic acid, HIV naïve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Sheba Medical Center, Rambam Health Care Campus
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is bone mass deterioration is significant even with the new medication currently used to treat HIV?
- 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:
- Provide blood samples for bone markers before antiviral treatment initiation and at 6M,12M,24M and 48M after treatment initiation
- Perform DXA scan soon after antiviral treatment initiation and after 12M ,24 M and 48 months
- 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.
- Patients with substantial osteoporosis will be treated according to standard of care by their HMO, but will continue followup in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zoledronic acid | Experimental | Drug: Zoledronic Acid 5 mg/Bag 100 ml InjPatients 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. |
| Follow up-comparator | No intervention | –Patients with T score from -1 to -2.4 that will be followed without intervention |
| mildly osteopenic patients | No 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 |
| Osteoporotic patients | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults over age of 18 years old of any gender, social, religious or racial background.
- Confirmed positive result for HIV infection.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic Acid 5 mg/Bag 100 ml InjZolendric acid will be provided to HIV naïve patients with documented osteopnia | Drug | Zoledronic acid |
Primary outcome
Bone density at 12 months.
Time frame: 12 months of initiation of ART
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
5 secondary outcomes
Bone density at 24 months.
Time frame: 24 months
Bone density at 48 months.
Time frame: 48 months of initiation of ART
Bone fractures at 48 months
Time frame: 48 months of initiation of ART
Bone markers differences during folloe up
Time frame: 6,12,24,48 months after treatment intiation
BMD decline in TDF sparing ART
Time frame: 48 months of initiation of ART
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hila Elinav, Doctor principal investigator
Hadassah University Medical center
Eynat Kedem, Doctor principal investigator
Rambam Health Care Campus
Itzchak Levy, Proffesor principal investigator
Sheba Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoledronic Acid 5 mg/Bag 100 ml Inj in people with HIV Infected Individuals and Osteopenia, run by Hadassah Medical Organization at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hila Doctor Elinav, Doctor (+972587874340, hilaelinav@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density at 12 months. (time frame: 12 months of initiation of ART). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.