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NCT Number: NCT06762730

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

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.

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Key information

Conditions

HIV Infected Individuals Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rambam Medical Center, Haifa, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoledronic Acid 5 mg/Bag 100 ml Inj

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Bone density at 24 months.

    Time frame: 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.

  2. Bone density at 48 months.

    Time frame: 48 months of initiation of ART

    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.

  3. Bone fractures at 48 months

    Time frame: 48 months of initiation of ART

    To estimate the rates of clinical fractures among all participants over a minimum of 48 months and the difference, if any, between treatment arms.

  4. Bone markers differences during folloe up

    Time frame: 6,12,24,48 months after treatment intiation

    Identify difference in average blood levels of bone turnover markers between treatment arm and the non intervention arm during the follow-up period.

  5. BMD decline in TDF sparing ART

    Time frame: 48 months of initiation of 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Auryan Szalat, Doctor

CONTACT

[email protected]

+9725078743735

Hila Doctor Elinav, Doctor

CONTACT

[email protected]

+972587874340

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Rambam Health Care Campus
  • Sheba Medical Center

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2028
Study completion
2032
First posted
Jan 8, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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