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| Name | Class |
|---|---|
| Sheba Medical Center | OTHER_GOV |
| Rambam Health Care Campus | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid 5 mg/Bag 100 ml Inj | Drug | Zolendric acid will be provided to HIV naïve patients with documented osteopnia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Bone density at 48 months. |
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Inclusion Criteria:
Exclusion Criteria:
Patients who received previous pharmacological agents for the prevention of HIV infection.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hila Doctor Elinav, Doctor | Contact | +972587874340 | hilaelinav@gmail.com | |
| Auryan Szalat, Doctor | Contact | +9725078743735 | auryans@hadassah.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Hila Elinav, Doctor | Hadassah University Medical center | Principal Investigator |
| Eynat Kedem, Doctor | Rambam Health Care Campus | Principal Investigator |
| Itzchak Levy, Proffesor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Not yet recruiting | Haifa | Israel |
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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.
| 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. | 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. | 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. | 48 months of initiation of ART |
| Sheba Medical Center |
| Principal Investigator |
| Hadassah Hebrew University Medical Center | Recruiting | Jerusalem | 9112001 | Israel |
|
| Sheba Medical Center | Not yet recruiting | Ramat Gan | Israel |
|
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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