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. 2019 Mar 18;85(6):1072–1083. doi: 10.1111/bcp.13869

Table 2.

Bone resorption markers following 50‐mg odanacatib given once weekly (geometric mean % change from baseline for weeks 1 [at 168 hours], 4, and 12)

Phase PN Time point Population n a sCTx (ng/mL) uNTx/Cr (nmol BCE/mmol creatinine) uDPD/Cr (nmol/mmol creatinine) 1CTP (μg/L)
GM SE GM SE GM SE GM SE
1 0059 Week 1 PM women 9 −66.22 9.45 −50.66 4.33 −29.98 5.70 101.41c 17.48
Week 4b PM women 8–9 −67.59 7.06 −63.59 4.08 −30.31 12.14 103.83 16.12
014f , 11 Week 1 PM women 8 −46.97 21.96 −58.33 13.48 −25.11 24.34 NA ‐‐
Week 4 PM women 6–8 −62.35 12.91 −66.88 12.56 −32.40 10.02 NA ‐‐
039 Week 1 PM women 22 −47.03 4.76 −27.20 10.11 −35.62 7.66 60.97 7.78
Week 4 PM women 22 −49.05 6.29 −22.14 11.91 −25.06 8.74 53.64 7.75
Week 12 PM women 22 −45.87 6.16 −40.27 6.85 −30.36 7.56 76.78 10.94
059d , 19 Week 1 Healthy men (50–75 y) 20–21 −54.2 27.6 −27.0e 39.2 −29.4 31.2 42.7 36.7
PM women 10 −58.6 26.6 −44.7 40.7 −14.6 16.3 44.3 43.5
Week 4 Healthy men (50–75 y) 19–20 −52.5 28.3 −16.4 45.3 −19.8 52.0 55.5 38.5
PM women 9 −62.9 39.4 −42.8 17.3 −26.9 28.0 44.3 67.4
2/3 00424 Week 1 PM women 67–70 −65.06 2.87 −55.88 2.85 −28.63 2.60 NA ‐‐
Week 4 PM women 68–69 −73.21 2.45 −63.82 2.24 −33.87 3.14 NA ‐‐
Week 12 PM women 61–62 −69.63 3.49 −62.13 2.46 −34.61 3.83 NA ‐‐
022e, 30 Week 1 Osteoporotic men and PM women 61–64 −56.75 (−61.88,‐50.93) −49.39 (−54.28,‐43.98) −33.11 (−38.73,‐26.98) NA ‐‐
Week 4 Osteoporotic men and PM women 61–64 −74.07 (−77.75, −69.78) −62.19 (−66.06, 57.88) −46.50 (−51.72,‐40.71) NA ‐‐
Week 12 Osteoporotic men and PM women 61–64 −69.25 (−74.94, −62.28) −60.24 (−64.81,‐55.08) −39.75 (−46.00,‐32.77) NA ‐‐
05331 Week 12 Osteoporotic men 128–134 −65.56 1.56 −46.53 3.95 NA ‐‐ NA ‐‐
a

Range for n depends on the n per biomarker;

b

P005: Week 4 is actually Week 3;

c

P005: 1CTP is Week 1 Day 3 (not Week 1 Day 7 or 168 hours);

d

P059: variability is standard deviation, not standard error (SE). In addition, there was no Week 12‐time point;

e

P022: LS mean % change from baseline and 95% confidence intervals are presented; data are pooled as presented in CSR;

f

P014: variability is standard deviation, not SE.

sCTx = serum C‐telopeptides of type 1 collagen; uNTx/Cr = urinary aminoterminal crosslinked telopeptides of type 1 collagen to creatinine ratio; 1CTP = cross‐linked carboxy‐terminal telopeptide of type 1 collagen; uDPD/Cr = urinary deoxypyridinoline to creatinine ratio; PM = postmenopausal.