Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials M.A. Karsdal, I. Byrjalsen, P. Alexandersen,

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Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials M.A. Karsdal, I. Byrjalsen, P. Alexandersen, A. Bihlet, J.R. Andersen, B.J. Riis, A.C. Bay-Jensen, C. Christiansen Osteoarthritis and Cartilage Volume 23, Issue 4, Pages 532-543 (April 2015) DOI: 10.1016/j.joca.2014.12.019 Copyright © 2015 Osteoarthritis Research Society International Terms and Conditions

Fig. 1 CONSORT diagrams. Osteoarthritis and Cartilage 2015 23, 532-543DOI: (10.1016/j.joca.2014.12.019) Copyright © 2015 Osteoarthritis Research Society International Terms and Conditions

Fig. 1 CONSORT diagrams. Osteoarthritis and Cartilage 2015 23, 532-543DOI: (10.1016/j.joca.2014.12.019) Copyright © 2015 Osteoarthritis Research Society International Terms and Conditions

Fig. 2 JSW change s) at 12 and 24 months (LS means ± 95% CIs MMRM ANCOVA model). Open circles: Placebo; Closed circles: 0.8 mg oral sCT. Number of subjects Pla/sCT: A) month 0: 584/585; month 12: 478/427; month 24: 454/394; B) month 0: 508/520; month 12: 407/377; month 24: 337/300; C) month 0: 1092/1105; month 12: 885/804; month 24: 791/694; D) month 0: 580/578; month 12: 473/420; month 24: 444/382; E) month 0: 503/515; month 12: 403/372; month 24: 330/295; F) month 0: 1083/1093; month 12: 876/792; month 24: 774/677. Osteoarthritis and Cartilage 2015 23, 532-543DOI: (10.1016/j.joca.2014.12.019) Copyright © 2015 Osteoarthritis Research Society International Terms and Conditions

Fig. 3 Change in WOMAC total, pain, stiffness and function in target knee during the 24 month treatment period (LS means ± 95% CIs MMRM ANCOVA). Open circles: Placebo; Closed circles: 0.8 mg oral sCT. Number of subjects Pla/sCT: A) and J) screening: 583/585; month 1: 562/531; month 6: 509/449; month 12: 472/423; month 24: 448/392; B) and K) screening: 502/514; month 1: 485/464; month 6: 433/420; month 12: 402/368; month 18: 379/341; month 24: 334/294; C) and L) screening: 1085/1099; month 1: 1047/995; month 6: 942/869; month 12: 874/791; month 24: 782/686; D) screening: 584/585; month 1: 563/532; month 6: 515/457; month 12: 478/428; month 24: 454/394; E) screening: 507/520; month 1: 492/474; month 6: 440/426; month 12: 407/375; month 18: 387/345; month 24: 338/301; F) screening: 1091/1105; month 1: 1055/1006; month 6: 955/883; month 12: 885/803; month 24: 792/695; G) screening: 584/585; month 1: 563/532; month 6: 515/457; month 12: 479/428; month 24: 454/393; H) screening: 506/520; month 1: 491/474; month 6: 439/426; month 12: 406/376; month 18: 387/345; month 24: 338/301; I) screening: 1090/1105; month 1: 1054/1006; month 6: 954/883; month 12: 885/804; month 24: 792/694. Osteoarthritis and Cartilage 2015 23, 532-543DOI: (10.1016/j.joca.2014.12.019) Copyright © 2015 Osteoarthritis Research Society International Terms and Conditions

Fig. 4 Levels relative to baseline of urinary CTX-I, serum osteocalcin, and urinary CTX-II (LS means ± 95% CIs MMRM ANCOVA). Open circles: Placebo; Closed circles: 0.8 mg oral sCT. Number of subjects Pla/sCT: A) and G) month 0: 571/574; month 6: 490/438; month 12: 464/416; month 18: 441/383; month 24: 436/387; B) and H) month 0: 80/69; month 6: 79/68; month 12: 80/69; month 18: 76/67; month 24: 79/69; C) and I) month 0: 651/643; month 6: 569/506; month 12: 544/485; month 18: 517/450; month 24: 515/456; D) month 0: 577/578; month 6: 509/454; month 12: 474/424; month 24: 446/389; E) all time points 81/68; F) month 0: 658/646; month 6: 590/522; month 12: 555/492; month 24: 527/457. Osteoarthritis and Cartilage 2015 23, 532-543DOI: (10.1016/j.joca.2014.12.019) Copyright © 2015 Osteoarthritis Research Society International Terms and Conditions

Fig. 5 Geometric mean (+standard error) of plasma sCT 15 min post-dose in patients given 0.8 mg oral sCT with 50 mL of water in the morning after an overnight fasting period. For comparison studies in OA patients comparing day of treatment (modified with permission from ref. 17), OP patients comparing synthetic and recombinant sCT (modified with permission from ref. 26), and OP patients with different postdose mealtime is included (modifed with permission from ref. 24 and 25). Number of subjects CSMC021C2301: 129; CSMC021C2302: 140; OA Day 1: 26; OA Day 14: 26; OP synthetic sCT: 12; OP recomb sCT: 23; OP meal 10 min: 40; OP meal 30 min: 40; OP meal 60 min: 40. Osteoarthritis and Cartilage 2015 23, 532-543DOI: (10.1016/j.joca.2014.12.019) Copyright © 2015 Osteoarthritis Research Society International Terms and Conditions