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.
Adults over age of 18 years old of any gender, social, religious or racial background.
Confirmed positive result for 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
Parallel
Zoledronic Acid 5 mg/Bag 100 ml Inj
DrugZolendric acid will be provided to HIV naïve patients with documented osteopnia
Bone density at 12 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 12 months after ART initiation
Bone density at 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.
Bone density at 48 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 48 months of initiation of ART.
Bone fractures at 48 months
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
Identify difference in average blood levels of bone turnover markers between treatment arm and the non intervention arm during the follow-up period.
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Hadassah Medical Organization
Lead sponsor
Sheba Medical Center
Collaborator
Rambam Health Care Campus
Collaborator
