Zoledronic Acid for the Prevention of TDF-sparing ART-induced Bone Mass Density Loss in Treatment-naive HIV Positive Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zoledronic Acid 5 mg/Bag 100 ml Inj.
- Who it may be relevant to
- Registry conditions: HIV Infected Individuals, Osteopenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Zoledronic Acid 5 mg/Bag 100 ml Inj
Zolendric acid will be provided to HIV naïve patients with documented osteopnia
Primary outcome measures
- Bone density at 12 months. [Time frame: 12 months of initiation of ART]
Secondary outcome measures (5)
- Bone density at 24 months. [Time frame: 24 months]
- Bone density at 48 months. [Time frame: 48 months of initiation of ART]
- Bone fractures at 48 months [Time frame: 48 months of initiation of ART]
- Bone markers differences during folloe up [Time frame: 6,12,24,48 months after treatment intiation]
- BMD decline in TDF sparing ART [Time frame: 48 months of initiation of ART]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 3 centers
- Rambam Medical Center — Haifa
- Hadassah Hebrew University Medical Center — Jerusalem
- Sheba Medical Center — Ramat Gan
Identifiers
NCT: NCT06762730 · 012724-HMO-CTIL