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

Hadassah Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Osteopenia; HIV Infected Individuals

Treatments: Drug: Zoledronic Acid 5 mg/Bag 100 ml Inj

Study type: Interventional

Funder types: Other

Identifiers

NCT06762730

012724-HMO-CTIL

Details and patient eligibility

About

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. 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 4 patient groups

Zoledronic acid

Experimental group

Description:

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.

Treatment:

Drug: Zoledronic Acid 5 mg/Bag 100 ml Inj

Follow up-comparator

No Intervention group

Description:

Patients with T score from -1 to -2.4 that will be followed without intervention

mildly osteopenic patients

No Intervention group

Description:

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 group

Description:

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