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

Phase 4

Recruiting

• Conditions: HIV Infected Individuals; Osteopenia
• Interventions: Drug: Zoledronic Acid 5 mg/Bag 100 ml Inj

• Registration Number: NCT06762730
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-09
• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Primary Completion: 2028-12-01
• Study Completion: 2032-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoledronic acid	Zoledronic Acid 5 mg/Bag 100 ml Inj	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.

Primary Outcome Measures

Name	Time	Method
Bone density at 12 months.	12 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 12 months after ART initiation

Secondary Outcome Measures

Name	Time	Method
Bone density at 24 months.	24 months	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 24. ART.
Bone density at 48 months.	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.
Bone fractures at 48 months	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.
Bone markers differences during folloe up	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.
BMD decline in TDF sparing ART	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.

Trial Locations

Locations (3)

Rambam Medical Center; 🇮🇱 Hiafa, Israel

Hadassah Hebrew University Medical Center; 🇮🇱 Jerusalem, Israel

Sheba Medical Center; 🇮🇱 Tel Hashmer, Israel