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Table 3 Shifts in BMD T-scores# (baseline to Week 52; BMD population)

From: Bone and ocular safety of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a 52-week randomized study

 

Baseline T-score

Post-baseline T-score

≤−2.5

>−2.5 and ≤−1

>−1

Osteoporotic

Osteopenic

Normal

Shifts in T-scores for lumbar spine BMD (L2–L4)

 BGF MDI 320/18/9.6 μg (N = 128)

≤−2.5 (n = 0)

0

0

0

>−2.5 and ≤ −1 (n = 37)

0

35 (94.6)

2 (5.4)

>−1 (n = 91)

0

4 (4.4)

87 (95.6)

 BFF MDI 320/9.6 μg (N = 57)

≤−2.5 (n = 0)

0

0

0

>−2.5 and ≤−1 (n = 16)

0

14 (87.5)

2 (12.5)

>−1 (n = 41)

0

3 (7.3)

38 (92.7)

 GFF MDI 18/9.6 μg (N = 123)

≤−2.5 (n = 0)

0

0

0

>−2.5 and ≤−1 (n = 35)

0

26 (74.3)

9 (25.7)

>−1 (n = 88)

0

4 (4.5)

84 (95.5)

Shifts in T-scores for total hip BMD

 BGF MDI 320/18/9.6 μg (N = 128)

≤−2.5 (n = 0)

0

0

0

>−2.5 and ≤−1 (n = 52)

3 (5.8)

45 (86.5)

4 (7.7)

>−1 (n = 76)

0

5 (6.6)

71 (93.4)

 BFF MDI 320/9.6 μg (N = 57)

≤−2.5 (n = 0)

0

0

0

>−2.5 and ≤−1 (n = 18)

1 (5.6)

16 (88.9)

1 (5.6)

>− 1 (n = 39)

0

5 (12.8)

34 (87.2)

 GFF MDI 18/9.6 μg (N = 119)

≤−2.5 (n = 0)

0

0

0

>−2.5 and ≤−1 (n = 52)

1 (1.9)

50 (96.2)

1 (1.9)

>−1 (n = 67)

0

4 (6.0)

63 (94.0)

  1. Data are n (%). BMD Bone mineral density, BFF Budesonide/formoterol fumarate, BGF Budesonide/glycopyrrolate/formoterol fumarate, GFF Glycopyrrolate/formoterol fumarate, L Lumbar spine segment, MDI Metered dose inhaler. #: shifts are from baseline to the worst post-baseline value, : N = number of patients with available data for both baseline and post-baseline T-scores (non-missing)