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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults over age of 18 years old of any gender, social, religious or racial background.

• Confirmed positive result for HIV infection.

Locations
Other Locations
Israel
Rambam Medical Center
NOT_YET_RECRUITING
Haifa
Hadassah Hebrew University Medical Center
RECRUITING
Jerusalem
Sheba Medical Center
NOT_YET_RECRUITING
Ramat Gan
Contact Information
Primary
Hila Doctor Elinav, Doctor
hilaelinav@gmail.com
+972587874340
Backup
Auryan Szalat, Doctor
auryans@hadassah.org.il
+9725078743735
Time Frame
Start Date: 2024-12-09
Estimated Completion Date: 2032-12-01
Participants
Target number of participants: 110
Treatments
Experimental: Zoledronic acid
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.
No_intervention: Follow up-comparator
Patients with T score from -1 to -2.4 that will be followed without intervention
No_intervention: mildly osteopenic patients
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
No_intervention: Osteoporotic patients
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
Related Therapeutic Areas
Sponsors
Collaborators: Sheba Medical Center, Rambam Hospital, Haifa, Israel
Leads: Hadassah Medical Organization

This content was sourced from clinicaltrials.gov