Bone Mineral Density in HIV-Negative Men Participating in a Tenofovir Pre-Exposure Prophylaxis Randomized Clinical Trial in San FranciscoReportar como inadecuado




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Background

Pre-exposure prophylaxis PrEP trials are evaluating regimens containing tenofovir-disoproxil fumarate TDF for HIV prevention. We determined the baseline prevalence of low bone mineral density BMD and the effect of TDF on BMD in men who have sex with men MSM in a PrEP trial in San Francisco.

Methods-Findings

We evaluated 1 the prevalence of low BMD using Dual Energy X-ray Absorptiometry DEXA in a baseline cohort of 210 HIV-uninfected MSM who screened for a randomized clinical trial of daily TDF vs. placebo, and 2 the effects of TDF on BMD in a longitudinal cohort of 184 enrolled men. Half began study drug after a 9-month delay to evaluate changes in risk behavior associated with pill-use. At baseline, 20 participants 10% had low BMD Z score≤−2.0 at the L2–L4 spine, total hip, or femoral neck. Low BMD was associated with amphetamine OR = 5.86, 95% CI 1.70–20.20 and inhalant OR = 4.57, 95% CI 1.32–15.81 use; men taking multivitamins, calcium, or vitamin D were less likely to have low BMD at baseline OR = 0.26, 95% CI 0.10–0.71. In the longitudinal analysis, there was a 1.1% net decrease in mean BMD in the TDF vs. the pre-treatment-placebo group at the femoral neck 95% CI 0.4–1.9%, 0.8% net decline at the total hip 95% CI 0.3–1.3%, and 0.7% at the L2–L4 spine 95% CI −0.1–1.5%. At 24 months, 13% vs. 6% of participants experienced >5% BMD loss at the femoral neck in the TDF vs. placebo groups p = 0.13.

Conclusions

Ten percent of HIV-negative MSM had low BMD at baseline. TDF use resulted in a small but statistically significant decline in BMD at the total hip and femoral neck. Larger studies with longer follow-up are needed to determine the trajectory of BMD changes and any association with clinical fractures.

Trial Registration

ClinicalTrials.gov: NCT00131677



Autor: Albert Y. Liu , Eric Vittinghoff, Deborah E. Sellmeyer, Risha Irvin, Kathleen Mulligan, Kenneth Mayer, Melanie Thompson, Robert G

Fuente: http://plos.srce.hr/



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