Antiresorptive effect of a cathepsin K inhibitor ONO-5334 and its relationship to BMD increase in a phase II trial for postmenopausal osteoporosis

Table 1 Baseline Characteristics of the Study Population

Study	MAD^a	PKPD^b	OCEAN^d
Subjects/Patients	Postmenopausal women	Postmenopausal women	Postmenopausal women with osteoporosis or osteopenia
Number of subjects/ patients	27	10	278
Race	100% Caucasian	100% Caucasian	100% Caucasian
Age (Mean (SD), year)	60.6 (5.7)	63.2 (4.7)	65.3 (4.8)
Weight (Mean (SD), kg)	69.8 (7.4)	71.1 (9.8)	65.4 (9.8)
Height (Mean (SD), cm)	165.2 (5.0)	160.3 (6.0)	160.1 (5.9)
BMI (Mean (SD), kg/m²)	25.6 (2.4)	27.6 (2.7)	25.5 (3.7)
Serum CTX (Mean (SD), ng/mL)	0.550 (0.209)	0.898 (0.171)^c	0.739 (0.249)
Urine CTX (Mean (SD), μmol/mmol creatinine)	215 (91)	361 (165)	296 (128)

^aOnly 50 mg BID, 100 mg QD and 300 mg QD groups in 15-day cohort. The original study was reported by Nagase et al. [31]
^bValue of all predose [28]
^cBaseline data of the first period
^dFull analysis set in the OCEAN study [16]

ISSN: 1471-2474