How to Prevent Bone Loss in HIV Patients Undergoing Antiretroviral Therapy
New approach could prevent bone loss induced by antiretroviral therapy in HIV patients.
Results of a phase 2 clinical trial found that a single dose of zoledronic acid could prevent bone loss in HIV patients undergoing antiretroviral therapy (ART).
The results of the trial were presented at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) by researchers from Emory University School of Medicine.
The study looked at 343 patients between the ages of 30 and 50-years-old with HIV who had no history of immunological disease besides HIV, had no signs of osteoporosis, had serum vitamin D and calcium levels within the normal range, as well as normal CBC and blood chemistry profiles.
Patients who had planned or recently had invasive dental procedures, active peptic ulcer disease, recent history of GI bleed, osteoporosis, or were pregnant or breastfeeding at the time were excluded from the study.
There were 63 patients selected to randomly receive ART and placebo or ART and zoledronic acid.
The results of the study showed that at 12 and 24 weeks, those who were in the group administered zoledronic acid had a 73% reduction in bone loss compared with 65% in the placebo groups.
Every person in the placebo group experienced enhanced bone loss and compensatory increase in bone formation, while those in the treatment group had a rise in bone loss and was flat in bone formation.
Treatment had no impact on the rate of viral suppression or immunologic response. Bone loss was higher in men than women in the placebo group and protection against bone loss was higher in men than women in the treatment group.
They also saw an 8% increase in lumbar spine bone marrow density at 12 weeks in the zoledronic acid group, compared with an 11% increase at 24 to 48 weeks in the placebo group.
The study lasted 48 weeks and only used a small sample size at a single site. It consisted of mostly male African-Americans. Researchers plan next to conduct a larger multicenter study in the future to back up their findings.
"We are encouraged that our protocol was able to prevent bone loss in HIV patients on ART therapy," said study co-author Igho Ofotokun, PhD. "These effects occurred early and last through 48 weeks, which is the period when ART-induced bone loss is most intense. This could be an opportunity for effective prophylaxis for preventing bone loss."