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Date of download: 7/6/2016 From: Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial Ann Intern Med. 2015;162(12):815-824.

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Presentation on theme: "Date of download: 7/6/2016 From: Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial Ann Intern Med. 2015;162(12):815-824."— Presentation transcript:

1 Date of download: 7/6/2016 From: Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial Ann Intern Med. 2015;162(12):815-824. doi:10.7326/M14-1409 Study flow diagram. BMD = bone mineral density; DXA = dual-energy x-ray absorpiometry; EFV/FTC/TDF = efavirenz/emtricitabine/tenofovir disoproxil fumarate; MI = multiple imputation. * Randomization was done by a central research data center, the Frontier Science & Technology Research Foundation, which supports research for AIDS Clinical Trials Group. † 1 of the 9 patients counted as not completing the study was excluded from the analysis due to an eligibility violation. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

2 Date of download: 7/6/2016 From: Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial Ann Intern Med. 2015;162(12):815-824. doi:10.7326/M14-1409 25-(OH)D 3 levels at baseline, 24 wk, and 48 wk, by study group. Data are median values, with error bars representing first and third quartiles (25th and 75th percentiles). From entry to 24 and 48 wk, 25-(OH)D 3 levels did not significantly change in the placebo group (median change, −0.6 ng/mL [IQR, −5.9 to 5.0] and 0.7 ng/mL [IQR, −5.3 to 4.3], respectively), but levels increased significantly in the vitamin D 3 plus calcium group (median change, 28.6 ng/mL [IQR, 15.0 to 38.0] and 24.5 ng/mL [IQR, 14.6 to 37.8], respectively; P < 0.001 at both time points). The change in the 25-(OH)D 3 levels was greater in the vitamin D 3 plus calcium group than in the placebo group at both 24 and 48 wk (P < 0.001 for both). To convert 25- (OH)D 3 values from ng/mL to nmol/L, multiply by 2.496. 25-(OH)D 3 = 25-hydroxyvitamin D 3 ; IQR = interquartile range. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

3 Date of download: 7/6/2016 From: Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial Ann Intern Med. 2015;162(12):815-824. doi:10.7326/M14-1409 Percentage of BMD change from baseline to 48 wk. The lines inside the boxes indicate the median values, the lower and upper edges of the boxes indicate the first and third quartiles (25th and 75th percentiles), and the lower and upper whiskers represent ±1.5 times IQR. Observations outside the whiskers are identified as outliers (squares). Median percentage declined significantly for both groups (P < 0.001 for both sites and groups). The median percentage of decline in total BMD of the hip was significantly smaller in the vitamin D 3 plus calcium group (−1.46% [IQR, −3.16% to −0.40%]) than in the placebo group (−3.19% [IQR, −5.12% to −1.02%]) (P = 0.001, stratified Wilcoxon rank sum test). The difference in total BMD of the lumbar spine between groups was of similar magnitude as that of the hip, but it did not achieve statistical significance: The differences were −1.41% (IQR, −3.78% to 0%) in the vitamin D 3 plus calcium group and −2.91% (IQR, −4.84% to −1.06%) in the placebo group (P = 0.085). BMD = bone mineral density; IQR = interquartile range. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

4 Date of download: 7/6/2016 From: Vitamin D and Calcium Attenuate Bone Loss With Antiretroviral Therapy Initiation: A Randomized Trial Ann Intern Med. 2015;162(12):815-824. doi:10.7326/M14-1409 Percentage of changes in bone turnover markers and PTH levels at 24 and 48 wk. Data are median percentages of increase from baseline, with error bars representing first and third quartiles (25th and 75th percentiles). Levels of P1NP and CTX increased significantly from baseline to 24 and 48 wk in both groups (P 0.088 for both). In the vitamin D 3 plus calcium group, there was no significant change in PTH levels at 24 or 48 wk (P > 0.31 for both), and the placebo group had a significant increase at 24 and 48 wk (P < 0.001 for both). The between-group differences were statistically significant for both time points (P = 0.011 at 24 wk; P = 0.004 at 48 wk). CTX = C-terminal telopeptide of type 1 collagen; P1NP = procollagen-1 N- terminal peptide; PTH = parathyroid hormone. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians


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