Table 5

Biochemical markers of bone formation and resorption

	Reference range	FP400 (n=22)	BDP800 (n=20)	p value FP-BDP^5-150	FP750 (n=13)	BDP1500 (n=13)	p value FP-BDP^5-150
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).