title: Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial.
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.
  
  
  METHODS
  48-week prospective, randomized, double-blind, placebo-controlled study. (ClinicalTrials.gov: NCT01403051).
  
  
  METHODS
  39 AIDS Clinical Trials Group units.
  
  
  METHODS
  Adults with antiretroviral therapy-naive HIV.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  No international sites were included, and follow-up was only 48 weeks.
  
  
  CONCLUSIONS
  Vitamin D3 plus calcium supplementation mitigates the BMD loss seen with initiation of efavirenz/emtricitabine/tenofovir disoproxil fumarate.
authors.forename: Edgar Turner
authors.initials: ET
authors.lastname: Overton
authors.forename: Ellen S
authors.initials: ES
authors.lastname: Chan
authors.forename: Todd T
authors.initials: TT
authors.lastname: Brown
authors.forename: Pablo
authors.initials: P
authors.lastname: Tebas
authors.forename: Grace A
authors.initials: GA
authors.lastname: McComsey
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Melbourne
authors.forename: Andrew
authors.initials: A
authors.lastname: Napoli
authors.forename: William Royce
authors.initials: WR
authors.lastname: Hardin
authors.forename: Heather J
authors.initials: HJ
authors.lastname: Ribaudo
authors.forename: Michael T
authors.initials: MT
authors.lastname: Yin
mesh_terms: D015502:Absorptiometry, Photon; D000328:Adult; D044966:Anti-Retroviral Agents / Q000009:adverse effects*; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001862:Bone Resorption; D002112:Calcifediol / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D002119:Calcium Carbonate / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000188:drug therapy; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced / Q000517:prevention & control*; D010281:Parathyroid Hormone / Q000097:blood; D011446:Prospective Studies
chemical_list: D044966:Anti-Retroviral Agents; D015415:Biomarkers; D050071:Bone Density Conservation Agents; D010281:Parathyroid Hormone; D002119:Calcium Carbonate; D002112:Calcifediol