Reference range |
FP400 (n=22) |
BDP800 (n=20) | p value FP-BDP5-150 |
FP750 (n=13) |
BDP1500 (n=13) | p value FP-BDP5-150 | |
Bone formation: | |||||||
Osteocalcin (μg/l) | 2.4–11.7 | 5.3 | 5.5 | 4.7 | 5.6 | ||
Interquartile range | 4.2–5.8 | 4.8–6.2 | 4.0–5.4 | 3.3–7.2 | |||
6 months | |||||||
Median change | −0.30 | 0.30 | NS | 0.95 | 0.30 | NS | |
Quartile change | −1.40, 1.60 | −1.00, 2.20 | −0.55, 1.75 | −1.40, 1.10 | |||
12 months | |||||||
Median change | 0.10 | −1.05 | 0.047 | −0.45 | −0.60 | NS | |
Quartile change | −1.40, 0.90 | −1.80, −0.20 | −0.80, 0.80 | −1.85, 0.17 | |||
PICP (μg/l) | 40–200 | 117 | 134 | 112 | 136 | ||
Interquartile range | 92–131.0 | 102–170 | 92–131 | 108–161 | |||
6 months | |||||||
Median change | −5.7 | −8.5 | NS | 6.0 | −9.0 | NS | |
Quartile change | −25.0, 12.3 | −35.0, 7.0 | 2.0, 34.0 | −18.0, 8.0 | |||
12 months | |||||||
Median change | 5.5 | −4.0 | NS | 7.5 | 1.5 | NS | |
Quartile change | −11.6, 15.5 | −29.0, 8.0 | −17.0, 21.0 | −37.0, 9.5 | |||
Serum alkaline phosphatase (μ/l) | <65 | 20 | 22 | 20 | 19 | ||
Interquartile range | 14–28 | 19–28 | 14–25 | 16–25 | |||
6 months | |||||||
Median change | 0.0 | −1.5 | NS | −4.0 | 3.5 | NS | |
Quartile change | −3.0, 4.0 | −5.0, 2.0 | −9.0, 5.0 | −4.0, 8.5 | |||
12 months | |||||||
Median change | 4.0 | 3.5 | NS | 3.0 | −1.0 | NS | |
Quartile change | 0.0, 6.0 | −1.5, 9.0 | −1.0, 5.0 | −3.5, 6.5 | |||
Serum creatinine (μmol/l) | M70-105 | 94 | 94 | 96 | 92 | ||
Interquartile range | F60-90 | 83–102 | 83–100 | 89–102 | 82–96 | ||
6 months | |||||||
Median change | 0.0 | 0.0 | NS | −0.5 | −2.0 | NS | |
Quartile change | −4.0, 6.0 | −5.5, 3.5 | −3.0, 4.0 | −7.0, 0.0 | |||
12 months | |||||||
Median change | −1.0 | 0.0 | NS | −3.0 | −2.0 | NS | |
Quartile change | −6.0, 3.0 | −4.0, 5.0 | −6.0, 0.0 | −7.0, 0.5 | |||
Serum calcium (mmol/l) | 2.1–2.6 | 2.33 | 2.30 | 2.33 | 2.31 | ||
Interquartile range | 2.28–2.38 | 2.28–2.33 | 2.27–2.38 | 2.29–2.35 | |||
6 months | |||||||
Median change | −0.005 | −0.015 | NS | 0.020 | 0.020 | NS | |
Quartile change | −0.050, 0.080 | −0.060, 0.040 | −0.040, 0.055 | −0.030, 0.040 | |||
12 months | |||||||
Median change | −0.010 | 0.000 | NS | −0.005 | 0.060 | NS | |
Quartile change | −0.050, 0.070 | −0.040, 0.030 | −0.060, 0.060 | −0.005, 0.085 | |||
Bone resorption: | |||||||
ICTP (μg/l) | 1.8–5.0 | 2.5 | 3.0 | 2.5 | 2.5 | ||
Interquartile range | 1.9–2.8 | 2.4–3.4 | 2.4–3.4 | 2.3–2.9 | |||
6 months | |||||||
Median change | −0.05 | −0.40 | NS | 0.30 | −0.30 | 0.031 | |
Quartile change | −0.50, 0.40 | −0.8, 0.05 | 0.00, 0.50 | −0.60, 0.10 | |||
12 months | |||||||
Median change | −0.30 | −0.20 | NS | −0.30 | −0.50 | NS | |
Quartile change | −0.70, 0.20 | −0.90, 0.10 | −0.75, 0.4 | −0.70, −0.05 | |||
Hydroxyproline (μmol/l) | 100–400 | 143 | 137 | 184 | 116 | ||
Interquartile range | 116–228 | 108–198 | 128–212 | 96–166 | |||
6 months | |||||||
Median change | 16 | 6 | NS | 27 | −21 | NS | |
Quartile change | −48, 62 | −35, 41 | −70, 69 | −48, 2 | |||
12 months | |||||||
Median change | 45 | 22 | NS | 31 | −8 | NS | |
Quartile change | −26, 120 | −41, 69 | −74, 51 | −63, 30 | |||
Urine calcium (mmol/l) | 1.0–7.0 | 3.92 | 3.39 | 3.13 | 2.10 | ||
Interquartile range | 2.58, 4.71 | 2.12, 5.98 | 1.79, 4.34 | 1.22, 2.17 | |||
6 months | |||||||
Median change | −0.27 | 0.18 | NS | 0.22 | 0.23 | NS | |
Quartile change | −0.77, 1.10 | −1.60, 1.00 | −0.88, 0.60 | −0.15, 0.84 | |||
12 months | |||||||
Median change | −0.07 | 0.04 | NS | −0.05 | 0.26 | NS | |
Quartile change | −1.71, 1.60 | −2.15, 1.73 | −1.78, 0.93 | −0.22, 0.90 | |||
Urine phosphate (mmol/l) | 15–45 | 24.5 | 27.8 | 23.9 | 12.0 | ||
Interquartile range | 16.8–31.5 | 15.4–35.4 | 15.9–29.9 | 9.4–15.0 | |||
6 months | |||||||
Median change | −0.3 | −2.2 | NS | 2.8 | −2.2 | NS | |
Quartile change | −4.2, 3.8 | −12.2, 5.0 | −9.6, 13.6 | −4.2, 0.2 | |||
12 months | |||||||
Median change | −1.6 | −4.2 | NS | 2.0 | −1.7 | NS | |
Quartile change | −6.6, 6.0 | −15.8, 3.4 | −16.0, 5.8 | −6.2, 2.6 | |||
Deoxypyridinoline:creatinine ratio | 2.5–9.5 | 3.7 | 3.9 | 4.4 | 3.9 | ||
Interquartile range | 3.4–4.4 | 3.6–5.4 | 3.4–4.8 | 3.5–5.7 | |||
6 months | |||||||
Median change | 0.05 | 0.10 | NS | 0.80 | 0.00 | NS | |
Quartile change | −0.80, 0.80 | −1.30, 0.35 | −0.90, 1.55 | −0.80, 0.80 | |||
12 months | |||||||
Median change | −0.10 | −0.65 | NS | 0.00 | 0.45 | NS | |
Quartile change | −1.15, 0.45 | −1.6, 0.05 | −0.50, 0.80 | −1.35, 1.95 |
FP400 = fluticasone propionate 400 μg/day (200 μg bd); FP750 = fluticasone propionate 750 μg/day (375 μg bd); BDP800 = beclomethasone dipropionate 800 μg/day (400 μg bd); BDP1500 = beclomethasone dipropionate 1500 μg/day (750 μg bd); PICP = procollagen type I carboxy terminal propeptide; ICTP = carboxy terminal cross linked telopeptide of type I collagen.
↵5-150 p value FP-BDP = significance derived from Wilcoxon rank sum test (difference between treatments in change from baseline).