HIV Infected Individuals, Osteopenia
Conditions
Keywords
Osteopenia, zoledronic acid, HIV naïve
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.
Interventions
Zolendric acid will be provided to HIV naïve patients with documented osteopnia
Sponsors
Sheba Medical Center
Rambam Hospital, Haifa, Israel
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone density at 12 months. | 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
| Measure | Time frame | Description |
|---|---|---|
| Bone density at 24 months. | 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. | 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. |
Countries
Israel
Contacts
Primary ContactHila Doctor Elinav, Doctor
Backup ContactAuryan Szalat, Doctor
Outcome results
None listed