Table 3.
Bone Mineral Density (BMD) Change from Baseline in 133 Subjects with Follow-Up DXA at Femoral Neck (n=112) and/or Lumbar Spine (n=128)
| Baseline Characteristics | BMD Change from Baseline Mean (95% CI) | |||||||
|---|---|---|---|---|---|---|---|---|
| FN | LS | |||||||
| mg/cm3 | P# | % | P# | mg/cm3 | P# | % | P# | |
| Age <50 years | −6.2 (−25.5, 13.1) | 0.10 | −0.6 (−3.1, 1.9) | 0.08 | 19.0 (1.7, 36.6)* | 0.40 | 2.2 (0.2, 4.2)* | 0.38 |
| Age ≥50 years | 17.8 (−2.4, 37.9) | 2.9 (0.0, 5.7) | 9.0 (−6.6, 24.5) | 1.1 (−0.6, 2.8) | ||||
| Men | 8.1 (−9.1, 25.3) | 0.97 | 1.4 (−1.0, 3.8) | 0.99 | 12.2 (−0.3, 24.7) | 0.79 | 1.4 (0.1, 2.8)* | 0.75 |
| Women | 7.5 (−19.0, 34.0) | 1.5 (−2.1, 5.0) | 15.6 (−11.3, 42.5) | 1.9 (−1.3, 5.1) | ||||
| BMI<25.0 kg/m2 | 3.7 (−17.2, 24.5) | 0.46 | 1.0 (−1.9, 4.0) | 0.61 | −2.2 (−16.4, 12.0) | 0.0008 | −0.1 (−1.7, 1.5) | 0.002 |
| BMI≥25.0 kg/m2 | 14.5 (−2.8, 31.9) | 2.1 (−0.2, 4.4) | 37.1 (17.2, 55.0)* | 4.1 (2.1, 6.1)* | ||||
| Experienced | 10.0 (−6.8, 26.8) | 0.55 | 1.7 (−0.6, 4.1) | 0.55 | 16.9 (4.7, 29.2)* | 0.21 | 2.0 (0.6, 3.4)* | 0.16 |
| Naive | −1.0 (−23.9, 21.9) | 0.2 (−2.7, 3.1) | −1.1 (−31.4, 29.3) | −0.2 (−3.5, 3.0) | ||||
| TDF in previous regimen§ | −11.2 (−36.4, 11.9) | 0.02 | −1.4 (−4.5, 1.6) | 0.01 | 12.9 (−5.2, 31.0) | 0.53 | 1.6 (−0.4, 1.6) | 0.56 |
| No TDF in previous regimen§ | 28.2 (6.0, 50.4)* | 4.4 (1.1, 7.8)* | 20.7 (3.5, 37.9)* | 2.4 (0.4, 4.4)* | ||||
| PI in previous regimen§ | −2.5 (−35.0, 30.0) | 0.24 | 0.0 (−4.3, 4.2) | 0.23 | 25.1 (0.0, 50.1)* | 0.28 | 3.2 (0.4, 6.1)* | 0.16 |
| No PI in previous regimen§ | 18.1 (−0.5, 36.8) | 2.9 (0.1, 5.6)* | 11.6 (−0.9, 24.1) | 1.2 (−0.2, 1.6) | ||||
| Normal BMD at baseline | −1.7 (−24.0, 20.6) | 0.22 | −0.3 (−2.9, 2.4) | 0.12 | 4.4 (−10.0, 18.8) | 0.16 | 0.4 (−1.0, 1.8) | 0.10 |
| Reduced BMD at baseline | 16.0 (−2.6, 34.6) | 2.9 (0.0, 5.7)* | 20.6 (3.1, 38.1)* | 2.5 (0.5, 4.6) | ||||
| Vitamin D supplement | −4.0 (−27.0, 19.0) | 0.19 | 0.6 (−3.0, 4.2) | 0.51 | 26.8 (7.7, 45.9)* | 0.09 | 3.4 (1.0, 5.7)* | 0.04 |
| No Vitamin D supplement | 15.3 (−3.0, 33.7) | 2.0 (−0.4, 4.3) | 6.0 (−8.4, 20.3) | 0.6 (−0.9, 6.1) | ||||
| 3TC/ABC/DTG | 5.2 (−9.6, 20.0) | 0.48 | 1.2 (−1.1, 2.4) | 0.57 | 19.1 (7.8, 30.5)* | 0.20 | 2.1 (0.8, 3.4)* | 0.24 |
| TDF/FTC/DTG | 1.8 (−78.6, 72.2) | 0.4 (−8.5, 9.3) | −12.4 (−70.5, 45.7) | −1.0 (−7.0, 4.9) | ||||
| Dual therapy | 11.8 (−29.4, 53.0) | 1.9 (−3.0, 6.7) | 17.2 (−23.2, 57.5) | 2.4 (−2.3, 7.0) | ||||
| Other Therapies | 66.0 (−18.2, 150.2) | 8.5 (−2.2, 19.2) | −18.3 (−52.9, 16.3) | −2.0 (−5.6, 1.6) | ||||
| Never smokers | −4.7 (−29.5, 4.1) | 0.73 | −0.3 (−3.5, 2.9) | 0.68 | 19.7 (2.9–36.6)* | 0.06 | 2.1 (0.4, 3.9)* | 0.06 |
| Former smokers | 4.0 (−72.6, 70.6) | 0.9 (−6.8, 8.6) | 23.0 (−11.6, 57.6) | 3.1 (−1.5, 7.7) | ||||
| Current smokers | 11.0 (−16.1. 38.1) | 2.1 (−2.8, 7.1) | −9.5 (−28.7, 9.8) | −0.9 (−3.1, 1.2) | ||||
Notes: #Comparison between groups, analysis of variance; *p<0.05 for change from baseline, paired t-test; §limited to experienced patients.
Abbreviations: BMD, bone mineral density; CI, confidence interval; FN, femoral neck; LS, lumbar spine; BMI, body mass index; TDF, tenofovir disoproxil fumarate; PI, protease inhibitors; 3TC, lamivudine; ABC, abacavir; DTG, dolutegravir; FTC, emtricitabine; smoking status was only reported in 88 patients.