Vitamin D and Calcium attenuate bone loss with antiretroviral therapy initiation: A Randomized Trial

Edgar Turner Overton, Ellen S. Chan, Todd T. Brown, Pablo Tebas, Grace A. McComsey, Kathleen M. Melbourne, Andrew Napoli, William Royce Hardin, Heather J. Ribaudo, Michael T. Yin

Research output: Contribution to journalArticle

Abstract

Background: Antiretroviral therapy initiation for HIV-1 infection is associated with 2% to 6% loss of bone mineral density (BMD). Objective: To evaluate the effect of vitamin D3 plus calcium supplementation on bone loss associated with antiretroviral therapy initiation. Design: 48-week prospective, randomized, double-blind, placebo-controlled study. (ClinicalTrials.gov: NCT01403051) Setting: 39 AIDS Clinical Trials Group units. Patients: Adults with antiretroviral therapy-naive HIV. Measurements: BMD by dual-energy x-ray absorptiometry, 25- hydroxyvitamin D levels, and other laboratory assessments. Results: 165 eligible patients were randomly assigned (79 received vitamin D3 plus calcium and 86 received placebo). The study groups were well-balanced at baseline: 90% were men, 33% were non-Hispanic black, and the median CD4 count was 0.341 × 109 cells/L. At 48 weeks, the percentage of decline in total hip BMD was smaller in the vitamin D3 plus calcium group than in the placebo group: Medians were -1.36% (interquartile range [IQR], -3.43% to 0.50%) and -3.22% (IQR, -5.56% to -0.88%), respectively (P = 0.004). Similar results were seen at the lumbar spine. At 48 weeks, 90% of patients achieved HIV-1 RNA levels less than 50 copies/mL. Levels of 25-hydroxyvitamin D3 increased with vitamin D3 plus calcium but not with placebo: Median change was 61.2 nmol/L (IQR, 36.4 to 94.3) versus 1.7 nmol/L (IQR, -13.2 to 10.7) (P ≤ 0.001). Overall, 103 patients (62%) reported 1 or more adverse event, with similar distribution between groups; no cases of hypercalcemia and 1 case of nephrolithiasis were reported in the placebo group.

Original languageEnglish (US)
Pages (from-to)815-824
Number of pages10
JournalAnnals of internal medicine
Volume162
Issue number12
DOIs
StatePublished - Jun 16 2015

ASJC Scopus subject areas

  • Internal Medicine

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    Overton, E. T., Chan, E. S., Brown, T. T., Tebas, P., McComsey, G. A., Melbourne, K. M., Napoli, A., Hardin, W. R., Ribaudo, H. J., & Yin, M. T. (2015). Vitamin D and Calcium attenuate bone loss with antiretroviral therapy initiation: A Randomized Trial. Annals of internal medicine, 162(12), 815-824. https://doi.org/10.7326/M14-1409