Table 2.
Changes in Bone Parameters over Study Period
Median (Q1, Q3) or no. (%) | HIV+ Combined (N=81) |
P° | Supplementation Dose* (N=51) |
P° | Standard Dose** (N=30) |
P° | P† |
---|---|---|---|---|---|---|---|
25(OH)D, ng/mL | +18.0 (+8.8, +32.0) | <0.001 | +42 (+33, +53) | <0.001 | +31 (+22, +37) | <0.001 | 0.001 |
PTH, pg/mL | +6.7 (−18.0, +19.9) | 0.30 | +7.2 (−11.5, +15.9) | 0.37 | +1.8 (−23.1, +25.0) | 0.60 | 0.91 |
% Δ in spine BMD | +2.4 (−0.08, +6.0) | <0.001 | +2.8 (−0.04, +7.2) | <0.001 | +1.4 (−0.16, +3.5) | 0.87 | 0.29 |
% Δ in hip BMD | +0.87 (−1.6, +2.8) | 0.08 | +0.93 (−0.7, +3.2) | 0.03 | +0.61 (−2.6, +2.1) | 0.002 | 0.37 |
Spine z-score | +0.1 (−0.1, +0.4) | 0.007 | +0.2 (−0.1, +0.4) | 0.005 | 0.0 (−0.6, +0.3) | 0.51 | 0.15 |
Hip z-score | 0.0 (−0.2, +0.2) | 0.44 | 0.0 (−0.2, +0.1) | 0.56 | −0.05 (−0.2, +0.2) | 0.50 | 0.68 |
Osteocalcin, ng/mL | −2.9 (−9.2, +3.8) | 0.03 | −3.3 (−10.1, +3.5) | 0.046 | −2.2 (−8.0, +4.42) | 0.34 | 0.67 |
B-CrossLaps, ng/mL | −0.09 (−0.24, +0.09) | 0.03 | −0.09 (−0.25, +0.06) | 0.01 | −0.07 (−0.19, +0.15) | 0.74 | 0.23 |
P1NP, ng/mL‡ | −6.7 (−21.0, +4.6) | 0.003 | −12.8 (−25.4, 0.0) | 0.001 | 0.0 (−13.1, +12.1) | 0.61 | 0.06 |
Supplementation dose = 60,000 IU/month (moderate dose) or 120,000 IU/month (high dose);
Standard dose = 18,000 IU/month (control dose);
P value for changes within group;
P value for differences in changes between the two dosing arms;
The upper limit of detection for P1NP was 300 ng/mL. At the 12-month time point, 11.8% and 23.3% of subjects in the supplementation and standard arms, respectively, had unmeasurable values above the upper limit and were assigned a value of 300 ng/mL for the purpose of calculation of change from baseline. Bold-faced P values indicate those <0.05.
Q, quartile; 25(OH)D, 25-hydroxyvitamin D; BMD, bone mineral density; P1NP, procollagen type 1 amino-terminal propeptide