Effects of novel cathepsin K inhibitor ONO-5334 on bone resorption markers: A study of four sustained release formulations with different pharmacokinetic patterns

Journal of Bone and Mineral Metabolism

Volumn 32, Issue 4, 2014, Pages 447-454

  Tanaka, Makoto ^a   Hashimoto, Yoshitaka ^a   Sekiya, Noboru ^a   Honda, Naoki ^a   Deacon, Steve ^a   Yamamoto, Masanobu ^a  

^a ONO PHARMACEUTICAL CO   (Japan)

Author keywords

Bone resorption; Cathepsin K inhibitor; ONO 5334; Osteoporosis

Indexed keywords

BIOLOGICAL MARKER; CARBOXY TERMINAL TELOPEPTIDE; CATHEPSIN K INHIBITOR; COLLAGEN TYPE 1; ONO 5334; UNCLASSIFIED DRUG; CATHEPSIN K; ONO-5334; THIAZOLIDINE DERIVATIVE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG GRANULE; DRUG SOLUBILITY; DRUG TOLERABILITY; FEMALE; HUMAN; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OPEN STUDY; OSTEOLYSIS; PLASMA CONCENTRATION-TIME CURVE; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SUSTAINED DRUG RELEASE; TABLET FORMULATION; TIME TO MAXIMUM PLASMA CONCENTRATION; ANTAGONISTS AND INHIBITORS; MIDDLE AGED; OSTEOPOROSIS; VERY ELDERLY;

AGED; AGED, 80 AND OVER; CATHEPSIN K; CROSS-OVER STUDIES; FEMALE; HUMANS; MIDDLE AGED; OSTEOPOROSIS; THIAZOLIDINES;

EID: 84904578588     PISSN: 09148779     EISSN: 14355604     Source Type: Journal    
DOI: 10.1007/s00774-013-0517-y     Document Type: Article

References (30)

1. Osteoporosis prevention, diagnosis, and therapy (2001) NIH consensus development panel on osteoporosis prevention, diagnosis, and therapy. JAMA 285:785-795
2. Inaoka T, Bilbe G, Ishibashi O, Tezuka K, Kumegawa M, Kokubo T (1995) Molecular cloning of human cDNA for cathepsin K: novel cysteine proteinase predominantly expressed in bone. Biochem Biophys Res Commun 206:89-96
3. Stoch SA, Wagner JA (2008) Cathepsin K inhibitors: a novel target for osteoporosis therapy. Clin Pharmacol Ther 83:172-176
4. Ravn P, Clemmesen B, Christiansen C (1999) Biochemical markers can predict the response in bone mass during alendronate treatment in early postmenopausal women. Alendronate Osteoporosis Prevention Study Group. Bone 24:237-244 (Pubitemid 29094566)
5. Garnero P, Borel O, Byrjalsen I, Ferreras M, Drake FH, McQueney MS, Foged NT, Delmas PD, Delaissé JM (1998) The collagenolytic activity of cathepsin K is unique among mammalian proteinases. J Biol Chem 273:32347-33252
6. Gelb BD, Shi GP, Chapman HA, Desnick RJ (1996) Pycnodysostosis, a lysosomal disease caused by cathepsin K deficiency. Science 273:1236-1238
7. Saftig P, Hunziker E, Wehmeyer O, Jones S, Boyde A, Rommerskirch W, Moritz JD, Schu P, von Figura K (1998) Impaired osteoclastic bone resorption leads to osteopetrosis in cathepsin-Kdeficient mice. Proc Natl Acad Sci USA 95:13453-13458 (Pubitemid 28522993)
8. Gowen M, Lazner F, Dodds R, Kapadia R, Feild J, Tavaria M, Bertoncello I, Drake F, Zavarselk S, Tellis I, Hertzog P, Debouck C, Kola I (1999) Cathepsin K knockout mice develop osteopetrosis due to a deficit in matrix degradation but not demineralization. J Bone Miner Res 14:1654-1663 (Pubitemid 29455813)
9. Adami S, Supronik J, Hala T, Brown JP, Garnero P, Haemmerle S, Ortmann CE, Bouisset F, Trechsel U (2006) Effect of one year treatment with the cathepsin-K inhibitor, balicatib, on bone mineral density (BMD) in postmenopausal women with osteopenia/ osteoporosis. J Bone Miner Res 21:S24
10. Bone HG, McClung MR, Roux C, Recker RR, Eisman JA, Verbruggen N, Hustad CM, DaSilva C, Santora AC, Ince BA (2010) Odanacatib, a cathepsin-K inhibitor for osteoporosis: a two-year study in postmenopausal women with low bone density. J Bone Miner Res 25:937-947
11. Eastell R, Nagase S, Ohyama M, Small M, Sawyer J, Boonen S, Spector T, Kuwayama T, Deacon S (2011) Safety and efficacy of the cathepsin K inhibitor ONO-5334 in postmenopausal osteoporosis: the OCEAN study. J Bone Miner Res 26:1303-1312
12. Wijkmans J, Gossen J (2011) Inhibitors of cathepsin K: a patent review (2004-2010). Expert Opin Ther Pat 21:1611-1629
13. Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, Bauer DC, Genant HK, Haskell WL, Marcus R, Ott SM, Torner JC, Quandt SA, Reiss TF, Ensrud KE (1996) Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 348:1535-1541 (Pubitemid 26411651)
14. Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, Lund B, Ethgen D, Pack S, Roumagnac I, Eastell R (2000) Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int 11:83-91 (Pubitemid 30099515)
15. Delmas PD, Recker RR, Chesnut CH III, Skag A, Stakkestad JA, Emkey R, Gilbride J, Schimmer RC, Christiansen C (2004) Daily and intermittent oral ibandronate normalize bone turnover and provide significant reduction in vertebral fracture risk: results from the BONE study. Osteoporos Int 15:792-798 (Pubitemid 39361949)
16. Black DM, Kelly MP, Genant HK, Palermo L, Eastell R, Bucci-Rechtweg C, Cauley J, Leung PC, Boonen S, Santora A, de Papp A, Bauer DC, Fracture Intervention Trial Steering Committee, HORIZON Pivotal Fracture Trial Steering Committee (2010) Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. N Engl J Med 362:1761-1771
17. Matsumoto T, Hagino H, Shiraki M, Fukunaga M, Nakano T, Takaoka K, Morii H, Ohashi Y, Nakamura T (2009) Effect of daily oral minodronate on vertebral fractures in Japanese postmenopausal women with established osteoporosis: a randomized placebo-controlled double-blind study. Osteoporos Int 20:1429-1437
18. Kumar S, Dare L, Vasko-Moser JA, James IE, Blake SM, Rickard DJ, Hwang SM, Tomaszek T, Yamashita DS, Marquis RW, Oh H, Jeong JU, Veber DF, Gowen M, Lark MW, Stroup G (2007) A highly potent inhibitor of cathepsin K (relacatib) reduces biomarkers of bone resorption both in vitro and in an acute model of elevated bone turnover in vivo in monkeys. Bone 40:122-131 (Pubitemid 44839339)
19. Langdahl B, Binkley N, Bone H, Gilchrist N, Resch H, Rodriguez Portales J, Denker A, Lombardi A, Le Bailly De Tilleghem C, Dasilva C, Rosenberg E, Leung A (2012) Odanacatib in the treatment of postmenopausal women with low bone mineral density: five years of continued therapy in a phase 2 study. J Bone Miner Res 27:2251-2258
20. Tanaka M, Yamada H, Mori H, Kunishige A, Nishikawa S, Hashimoto Y, Shiroya T (2010) Efficacy of ONO-5334, a cathepsin K inhibitor, on bone geometry and histomorphometry in cortical bone in ovariectomized cynomolgus monkeys. J Bone Miner Res 25:S349
21. Jerome C, Missbach M, Gamse R (2011) Balicatib, a cathepsin K inhibitor, stimulates periosteal bone formation in monkeys. Osteoporos Int 22:3001-3011
22. Cusick T, Chen CM, Pennypacker BL, Pickarski M, Kimmel DB, Scott BB, le Duong T (2012) Odanacatib treatment increases hip bone mass and cortical thickness by preserving endocortical bone formation and stimulating periosteal bone formation in the ovariectomized adult rhesus monkey. J Bone Miner Res 27:524-537
23. Baron R (2011) Osteoporosis in 2011: osteoporosis therapy-dawn of the post-bisphosphonate era. Nat Rev Endocrinol 8:76-78
24. Ochi Y, Yamada H, Mori H, Nakanishi Y, Nishikawa S, Kayasuga R, Kawada N, Kunishige A, Hashimoto Y, Tanaka M, Sugitani M, Kawabata K (2011) Effects of ONO-5334, a novel orally-active inhibitor of cathepsin K, on bone metabolism. Bone 49:1351-1356
25. Nagase S, Hashimoto Y, Small M, Ohyama M, Kuwayama T, Deacon S (2012) Serum and urine bone resorption markers and pharmacokinetics of cathepsin K inhibitor ONO-5334 after ascending single doses in post-menopausal women. Br J Clin Pharmacol 74:959-970
26. Nagase S, Ohyama M, Hashimoto Y, Small M, Kuwayama T, Deacon S (2012) Pharmacodynamic effects on biochemical markers of bone turnover and pharmacokinetics of the cathepsin K inhibitor, ONO-5334, in an ascending multiple-dose, phase 1 study. J Clin Pharmacol 52:306-318
27. Gandhi R, Lal Kaul C, Panchagnula R (1999) Extrusion and spheronization in the development of oral controlled-release dosage forms. Pharm Sci Technol Today 4:160-170 (Pubitemid 29195749)
28. MacGregor EA (2009) Headache and hormone replacement therapy in the postmenopausal woman. Curr Treat Options Neurol 11:10-17
29. Kurumatani H (2009) Pharmacological profiles and clinical effects of oral sustained release beraprost sodium (Careload LA tablets 60 lg, Berasus LA tablets 60 lg). Folia Pharmacol Jpn 133:101-111
30. Cristancho MA, Thase ME (2010) The role of quetiapine extended release in the treatment of bipolar depression. Adv Ther 27:774-784