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Treating ART-Associated Bone Loss With Alendronate

14 weeks of oral alendronate taken prior to ART had a sustained impact on prevention of bone loss at the hip.

People living with the human immunodeficiency virus (HIV) are known to have a higher prevalence of low bone mineral density (BMD) than the general population. This can lead to an increased risk of fractures and other bone injuries. Compounding the issue further, the initiation of the HIV care regimen called antiretroviral therapy (ART) has been shown to further accelerate this BMD loss.

A recent study has now analyzed whether the short-term use of the oral, generic bisphosphonate alendronate (ALN) has the potential to prevent BMD loss at ART initiation. The data was presented during the Conference on Retroviruses and Opportunistic Infections (CROI) 2021 virtual sessions.

The study, a multisite, double blinded, placebo-controlled phase 4 clinical trial, consisted of 50 participants who were initiating ART with tenofovir disproxil fumarate/emtricitabine and a third agent. They were randomized to receive calcium/vitamin D3 supplementation with either generic, oral ALN 70mg weekly or placebo (PL) for 2 weeks prior to ART initiation and for a total of 14 weeks. Clinical, laboratory, safety and BMD at lumbar spine (LS) and total hip (TH) were assessed at weeks 0, 14, 26 and 50

Of the participants, the median age was 35 and 86% were male, 46% were Caucasian, 34% were African and 20% were Hispanic. The third agent use comprised integrase inhibitors in 94% and protease inhibitors in 4%.

Findings from the study showed that BMD was not significantly different between the cohorts. At week 50, subjects in the ALN group had a median 0.50% increase in TH BMD compared to a 2.7% decrease in the PL group. At the LS, the ALN group had a 1.4% loss compared to 3.69% loss in the PL group.

Additional findings showed that TH BMD between-group differences were evident early at week 14. In contrast, at the LS, between group differences although evident at weeks 14, they didn't persist to week 50. ALN was well tolerated with no significant differences in adverse events between the groups.