Figures
- Fig. 1.—
Mean changes in bone mineral density (BMD) during the study, measured in a) lumbar spine (L2–L4), b) femoral neck, c) femoral trochanter and d) femoral Ward's triangle. ▪: budesonide 400 µg b.i.d.; •: placebo.
Tables
- Table 1
Baseline demographic characteristics of the radiograph (n=653) dual-energy X-ray absorptiometry (DEXA, n=161) and overall (n=912) study populations
Radiograph DEXA Overall study population Budesonide Placebo Budesonide Placebo Budesonide Placebo Subjects n 322 331 82 79 458 454 Age yrs 52 (31–65) 52 (25–65) 54 (31–64) 53 (36–64) 52 (31–65) 52 (25–65) Height cm 173.0 (152–194) 172.9 (150–198) 172.3 (155–189) 172.1 (154–192) 172.8 (152–194) 172.8 (150–198) Weight kg 75.5 (41–121) 73.7 (43–125) 77.4 (50–117) 74.8 (50–110) 74.9 (41–121) 73.6 (43–125) Duration of smoking yrs 35.5 (11–52) 35.7 (9–56) 36.2 (11–50) 36.4 (20–51) 36.0 (11–52) 36.0 (9–56) Total consumption g·day−1 14.8 (1.5–45) 13.5 (0.8–103.1) 16.1 (1.5–33.8) 16.3 (3.8–52.5) 1.50 (1.5–88.7) 13.7 (0.8–103.1) Cigarettes·day−1 19.3 (0–60) 17.1 (0–70) 21.0 (0–45) 20.9 (3–70) 19.1 (0–60) 17.6 (0–70) -
Data are presented as mean (range)
-
- Table 2
Baseline bone mineral density in patients for whom both baseline and end-of-treatment scans were available (n=16)
Budesonide Placebo Subjects n 82 79 Femoral neck g·cm2 0.89±0.15 (0.59–1.26) 0.85±0.16 (0.57–1.33) Femoral trochanter g·cm2 0.79±0.16 (0.38–1.21) 0.77±0.17 (0.45–1.22) Femoral Ward’s triangle g·cm2 0.69±0.19 (0.35–1.14) 0.66±0.20 (0.31–1.27) L2–L4 g·cm2 1.09±0.17 (0.58–1.59) 1.06±0.19 (0.67–1.60) -
Data are presented as mean ± sd (range)
-
- Table 3
Baseline bone mineral density at the end of the study
Budesonide Placebo Subjects n 78 71 Femoral neck g·cm2 0.88±0.15 (0.57–1.27) 0.85±0.15 (0.54–1.29) Femoral trochanter g·cm2 0.78±0.16 (0.33–1.19) 0.77±0.17 (0.48–1.22) Femoral Ward’s triangle g·cm2 0.68±0.18 (0.30–1.12) 0.66±0.18 (0.34–1.20) L2–L4 g·cm2 1.09±0.19 (0.56–1.68)# 1.06±0.19 (0.70–1.61)¶ -
Data are presented as mean±sd (range)
-
#: n=82
-
¶: n=79
-
- Table 4
Estimated difference in treatment effects on bone mineral density (budesonide and placebo)
Estimated difference Lower 95% CI Upper 95% CI p-value L2–L4 % change −0.52 −1.91 0.88 0.4667 Femoral neck % change −0.87 −2.58 0.85 0.3205 Femoral trochanter % change −1.62 −3.49 0.25 0.0895 Femoral Ward’s triangle % change −1.67 −4.84 1.50 0.2987 -
CI: Confidence interval
-
