Clinical trial NCT06762730: Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: HIV Infected Individuals
Osteopenia
Keywords: Osteopenia
zoledronic acid
HIV naïve
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Sheba Medical Center
name: Rambam Hospital, Haifa, Israel
First posted: 2025-01-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Bone density at 12 months.
timeFrame: 12 months of initiation of ART
Secondary outcomes:
measure: Bone density at 24 months.
timeFrame: 24 months
measure: Bone density at 48 months.
timeFrame: 48 months of initiation of ART
measure: Bone fractures at 48 months
timeFrame: 48 months of initiation of ART
measure: Bone markers differences during folloe up
timeFrame: 6,12,24,48 months after treatment intiation
measure: BMD decline in TDF sparing ART
timeFrame: 48 months of initiation of ART
Other outcomes:
Locations:
city: Hiafa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
city: Tel Hashmer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Hadassah University Medical center
name: Hila Elinav, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Eynat Kedem, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Itzchak Levy, Proffesor
role: PRINCIPAL_INVESTIGATOR
References: