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
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.