Vitamin D and Calcium Supplement Attenuate Bone Loss among HIVInfected Patients Receiving Tenofovir Disoproxil Fumarate/Emtricitabine/ Efavirenz: An Open-Label, Randomized Controlled Trial

Abstract

Background: Antiretroviral therapy (ART), especially with tenofovir disoproxil fumarate (TDF), has been associated with accelerated bone turnover and leads to significant bone loss. Objective: We aimed to determine the effect of vitamin D2 and calcium on bone mineral density (BMD) in HIV-infected patients receiving TDF/emtricitabine (FTC)/efavirenz (EFV). Methods: A prospective, open-label, randomized controlled study was conducted. Eligible patients were ART naïve HIV individuals who initiated TDF/FTC/EFV. The study group received supplementation with vitamin D2 and calcium carbonate, whereas the control group was administered only ART. The primary outcome was the percentage change in total hip BMD at week 24 compared with baseline. Results: A total of 18 patients were randomized (9 in each group). The mean (standard deviation; SD) total hip BMD significantly decreased from baseline in both groups, from 0.96 (0.14) g/cm2 to 0.93 (0.13) g/cm2 in the study group (p = 0.006) and from 0.87 (0.11) g/cm2 to 0.84 (0.11) g/cm2 in the control group (p = 0.004). The mean (SD) lumbar spine BMD significantly decreased from baseline in both groups, from 1.00 (0.13) g/cm2 to 0.97 (0.13) g/cm2 (p = 0.004) in the study group and from 0.90 (0.09) g/cm3 to 0.86 (0.08) g/cm2 in the control group (p = 0.006). At week 24, the mean (SD) lumbar spine BMD was significantly greater in the study group than in the control group (p = 0.042). However, there were no significant differences in the percentage change of total hip, lumbar spine, and femoral neck BMD between both groups. No adverse events were reported. In conclusion, as early as 24 weeks after TDF initiation, a significant decline in BMD was detected. Conclusion: Vitamin D2 and calcium supplements should be considered for HIV-infected patients receiving TDF/FTC/EFV in a resource-limited setting where there are limited ART options (Clinicaltrials. gov NCT0287643).

Effects of vitamin D and calcium supplementation on bone mineral density among Thai youth using daily HIV pre‐exposure prophylaxis

“…It is known that vitamin D supplementation improves TDF‐associated PTH elevations [19] and vitamin D plus calcium supplementation improves endocrinological and BMD changes associated with TDF use as treatment in HIV infection populations [26‐28]. To date, there are limited data demonstrating the effect of vitamin D and calcium supplementation in youth PrEP users.…”

Vitamin D and Calcium Supplementation Reverses Tenofovir-Caused Bone Mineral Density Loss in People Taking ART or PrEP: A Systematic Review and Meta-Analysis

“…Another study found similar results in HIV-negative populations taking PrEP ( 21 ). However, other studies did not find significant differences in changes of the hip and lumbar bone density among people living with HIV/AIDS (PLWHA) in both the VD and calcium supplementation group and the placebo group ( 26 ). Another study reported that there was no difference in the lumbar spine BMD in HIV-negative participants who participated in PrEP studies (−2.11 vs. −2.14%, p = 0.40) ( 27 ).…”

Risk of Fractures in Older Adults Living with HIV

“…Recent studies show that it is recommended a daily intake of calcium (1000mg/day) that is usually cover with a balanced diet (with protein). I case of low calcium intake, calcium and vitamin D supplements should be consider as they are known for lower bone mineral density loss [24]. Regulary physical activity should be promoted and stopping toxic habits just as smoking, use of drugs and alcohol.…”