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Table 2 Baseline and follow-up investigations overall and per treatment arm

From: A randomised controlled trial to examine the effects of cinacalcet on bone and cardiovascular parameters in haemodialysis patients with advanced secondary hyperparathyroidism

Mean (SD) / Median [range] / n (%)

All patients (n = 36)

Cinacalcet (n = 15)

Control (n = 21)

Estimated effect (CI)

p-Value

Baseline

12 months

Baseline

12 months

iPTH (pg/mL)

730 [318 to 1586]

665 [353 to1586]

225 [152 to 386]

806 [318 to 1096]

294 [145 to 445]

146 (− 240, 355)

0.7

Calcium (mmol/L)

2.30 (0.14)

2.32 (0.16)

2.34 (0.17)

2.29 (0.12)

2.39 (0.24)

0.08 (−0.3,0.03)

0.2

Phosphate (mmol/L)

1.91 (0.58)

1.91 (0.58)

1.62 (0.56)

1.91 (0.59)

1.61 (0.65)

0.2 (− 0.3,0.7)

0.5

Haemoglobin (g/L)

124 (15)

124 (18)

119 (20)

124 (14)

119 (13)

7.8 (−17, 36)

0.5

CRP

11 [0,97]

16 [0 to 97]

4 [0.6 to 17]

7 [0.5 to 52]

5 [1.6 to 7.4]

5.1 (−13.1, 8)

0.6

Medication

 Calcium Binder

15 (42%)

7 (47%)

8 (53%)

8 (38%)

7 (35%)

 

0.3

 Non-calcium binder

30 (83%)

13 (87%)

12 (80%)

17 (81%)

12 (60%)

 

0.3

 VDRA

35 (97%)

15 (100%)

14 (93%)

20 (95%)

20 (91%)

 

0.4

Vascular stiffness & Carotid intima media thickness

 cfPWV (m/s)

8.6 (3)

7.8 (2)

8 (2)

9.2 (3)

9.5 (2.6)

−0.2 (−1.6,1.2)

0.8

 Augmentation index (%)

21 [−10,+ 53]

21 [−5 to + 37]

21 [10 to 26]

26 [− 10 to + 53]

28 [16 to 35]

6 (−21, 4)

0.2

 Average CIMT (mm)

0.04 (0.01)

0.04 (0.01)

0.03 (0.01)

0.04 (0.01)

0.04 (0.01)

−0.004 (− 0.1,0.002)

0.2

Agatston calcification score

 Coronary calc score

204 [0 to 4075]

96 [0 to 4075]

106 [18 to 950]

260 [8 to 3785]

464 [60 to1480]

218 (− 502,387)

0.8

 Aortic calc score

892 [0 to 16,466]

302 [0 to 13,063]

480 [60 to 2224]

2090 [0 to 16,466]

2665 [895 to 8567]

393 (− 382,1224)

0.3

 Total calc score

2174 [0 to 16,635]

814 [0 to 15,090]

852 [165 to 5942]

3401 [7.5 to 16,635]

4768 [996 to 9582]

455 (− 564,1293)

0.4

 Cardiac magnetic resonance

(n = 32)

(n = 12)

 

(n = 20)

   

 LV mass index (g/m2)

109 (39)

120 (43)

92 (31)

103 (37)

90 (20)

−0.2 (−1.2,0.8)

0.7

 LV stroke volume (mL)

92 (22)

102 (22)

103 (24)

87 (19)

98 (22)

−0.5 (−16,15)

0.9

 LV ejection fraction (%)

68 (11)

70 (7)

70 (8)

67 (13)

70 (10)

−0.5 (−7,6)

0.9

Bone density

(n = 36)

(n = 15)

 

(n = 19)

   

 DXA spine BMD g/m2

1.1 (0.2)

1.1 (0.1)

1.1 (0.1)

1.1 (0.2)

1.1 (0.2)

−0.03 (−0.07,0.001)

0.1

 DXA hip BMD

0.9 (0.1)

0.9 (0.1)

0.9 (0.1)

0.8 (0.2)

0.8 (0.2)

−0.01 (−0.03,0.2)

0.4

 DXA femoral BMD

0.8 (0.1)

0.9 (0.1)

0.9 (0.1)

0.8 (0.1)

0.8 (0.2)

−0.01 (− 0.04,0.02)

0.6

 QCT BMD

126 (48)

134 (38)

136 (38)

120 (54)

120 (40)

−2.7 (−14,9.1)

0.6

 pQCT50 cortcnt

80 (30)

86 (23)

90 (21)

75 (33)

82 (27)

5.1 (−2.5,12.8)

0.2

 Stress strain index

215 (99)

227 (68)

244 (66)

207 (54)

202 (94)

28 (−3.8,59.6)

0.08

Biomarkers

 NTproBNP (pg/mL)

2945[332to161680]

2483[679to80840]

3066 [90to49520]

3011[332to161680]

3208 [107to126250]

0.01 (−0.4,0.4)

0.9

 Troponin T (ug/L)

33 [11 to 199]

27 [11 to 89]

30 [4 to 1478]

38 [12 to 198]

42 [14 to 131]

0.1 (−0.2,0.4)

0.5

 25(OH) Vitamin D (nmol/L)

13 [4 to 33]

16 [6 to 59]

16 [4 to 34]

11 [4 to 33]

13 [4 to 33]

−0.1 (−0.3,0.7)

0.2

 1,25 (OH)2 Vitamin D (pmol/L)

66 [34 to 132]

62 [34 to 130]

65 [50 to 91]

70 [39 to 132]

78 [54 to 122]

−0.1 (−0.3,0.8)

0.3

 Osteoprotegerin (pmol/L)

8 [3 to 23]

8 [3 to 17]

8 [3 to 18]

8 [4 to 23]

8 [4 to 17]

0.4 (−0.4,0.1)

0.3

 FGF23 (RU/mL)

13,794 [412 to 149,994]

22,243 [774 to 149,994]

7422 [328 to 117,011]

13,793 [412 to 60,933]

11,540 [195 to 143,782]

−0.06 (−0.6,0.5)

0.8

 Fetuin A (ng/mL)

342 [190 to 588]

363 [290 to 562]

369 [154 to 538]

321 [190 to 588]

343 [161 to 580]

−0.2 (−0.9,0.6)

0.7

  1. iPTH intact PTH, VDRA vitamin D receptor analogues, cfPWV carotid-femoral pulse wave velocity, CIMT carotid intima-media thickness, calc calcification, LV left ventricular, DXA Dual X-Ray Absorptiometry, BMD bone mineral density, QCT quantitative computerised tomography, pQCT50 peripheral QCT at 50% of forearm, crtcnt cortical content, NTproBNP N-Terminal Pro Brain Naturetic peptide, FGF23 fibroblast growth factor 23