Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals

NCT06762730 | Recruiting Phase 4 DMC

• 1 other identifier: 012724-HMO-CTIL
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

Brief 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. 1.Is bone mass deterioration is significant even with the new medication currently used to treat HIV?
2. 2.Can one dose of Zolendric acid protect from deterioration of bone mass.
3. 3.Provide blood samples for bone markers before antiviral treatment initiation and at 6M,12M,24M and 48M after treatment initiation
4. 4.Perform DXA scan soon after antiviral treatment initiation and after 12M ,24 M and 48 months
5. 5.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.
6. 6.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

Keywords

Osteopenia; zoledronic acid; HIV naïve

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (4)

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.

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

Interventions

Zoledronic Acid 5 mg/Bag 100 ml Inj DRUG

Zolendric acid will be provided to HIV naïve patients with documented osteopnia

Zoledronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over age of 18 years old of any gender, social, religious or racial background.
• Confirmed positive result for HIV infection.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Sheba Medical Center: collaborator
• Rambam Hospital, Haifa, Israel: collaborator

Study Sites (3)

Rambam Medical Center

Haifa, Israel

NOT YET RECRUITING

Hadassah Hebrew University Medical Center

Jerusalem, 9112001, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hila Elinav, Doctor

  Hadassah University Medical center

  PRINCIPAL INVESTIGATOR

• Eynat Kedem, Doctor

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

• Itzchak Levy, Proffesor

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hila Doctor Elinav, Doctor

CONTACT

+972587874340; hilaelinav@gmail.com

Auryan Szalat, Doctor

CONTACT

+9725078743735; auryans@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 8, 2025
• Study Start: December 9, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2032
• Last Updated: September 18, 2025

Record last verified: 2024-12

Locations

IL (3)