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03/06/2104

Vitamin D and Calcium Attenuates Bone Loss While on ART: CROI 2014


Several studies have shown higher rates of osteopenia and osteoporosis among HIV-infected individuals, that may be related to ART, as well as traditional risk factors such as low vitamin D levels, tobacco and alcohol use. Dr. Edgar Overton from the University of Alabama presented 48 week results of a randomized doubleblind placebo controlled controlled trial comparing placebo to vitamin D 4000 IU and calcium carbonate 1000mg daily among participants initiating efavirenz/emtricitabine/tenofovir. Participants were eligible if they had vitamin D levels between 10 and 75 ng/mL. Exclusion criteria included a history of bisphosphonate use, fragility fractures, nephrolithiasis, hypercalcemia, recent steroid use and any serious intercurrent illness. Baseline and followup DXA scans were obtained to evaluate changes in BMD. The primary endpoint was percentage change in total hip BMD, however changes in lumbar spine BMD, 25(OH) D levels, bone turnover and inflammatory markers were also evaluated. The vitamin D/calcium supplementation was well tolerated with only 1 discontinuation in the Vit D/Calcium arm compared with 2 in the placebo arm. A comparison of the study arms revealed a statistically significant higher 25(OH) D level, as well as 50% lower rate of total hip (p=0.085) and lumbar spine BMD decline among those receiving supplements (n=79) compared to placebo (n=86), as well as favorable changes in bone turnover markers (P1NP and CTX). During the question and answer session Dr. Overton stated it was possible that a lower dose of vitamin D could possibly also be effective at mitigating the bone loss associated with ART, however further studies were needed to determine optimal dose.

References:
1. McComsey GA, Kitch D, Daar ES, Tierney C, Jahed NC, Tebas P, Myers L, Melbourne K, Ha B, Sax PE. Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. J Infect Dis. 2011 Jun 15;203(12):1791-801. doi: 10.1093/infdis/jir188.
2. Brown TT, McComsey GA, King MS, Qaqish RB, Bernstein BM, da Silva BA. Loss of bone mineral density after antiretroviral therapy initiation, independent of antiretroviral regimen. J Acquir Immune Defic Syndr 2009;51((5)):554-561
3. Overton ET, Chan ES, Brown TT, Tebas P, McComsey GA, Melbourne KM, Napoli A, Hardin R, Ribaudo HJ, Yin MT, ACTG A5280 Study Team. High-Dose Vitamin D and Calcium Attenuates Bone Loss With ART Initiation: Results From ACTG A5280. Abstract 133, CROI 2014, Boston, MA, March 3-6, 2014.


Source: Reporting for PRN News: Anita Radix, MD