As a secondary objective, the spectrum and occurrence of SAEs while on therapy was analyzed after the selleck chemicals llc first dose of TPTD. Ethics The study protocol was approved by the study center Ethical Review Boards, and all patients provided written consent to release information before enrollment. The study was conducted in accordance with regulatory standards of Good PS-341 price Clinical Practice and the Declaration of Helsinki (1996). Results Participant characteristics
Of the 4,167 patients enrolled between August 2004 and February 2007 at 198 US investigator sites, 4,085 started open-label treatment phase with TPTD (safety population), 3,720 were included in the 24-month treatment phase (and comprised the efficacy population), and 1,066 completed the 24-month cessation phase (Fig. 1). Baseline characteristics for those patients included in the efficacy analysis FG4592 are presented in Table 1. The mean age of the female patients was 68.3 years (standard deviation [SD] = 11.5 years) and that of male patients
was 65.1 years (SD = 13.1 years); the men were significantly younger than the women (p < 0.001). The majority of women (87.8 %) and men (92.1 %) were Caucasian. Significantly more women than men had a family history of osteoporosis (39.8 versus 28.5 %, p < 0.001) and had previously been treated for osteoporosis (88.4 versus 61.5 %, p < 0.001). Women also had a lower mean lumbar spine bone mineral density (BMD) T-score (−2.51 versus −2.21, p = 0.003), and lower mean total hip BMD T-score (−2.20 versus −1.97, p = 0.002) than men at baseline. 1 Study flow diagram Table 1 Baseline characteristics of the DANCE study cohort Baseline characteristic Women (n = 3,350) Men (n = 369) Overall (n = 3,720a) Age, years (mean, SD) 68.3 (11.5)*** 65.1 (13.1) 68.0 (11.7) Ethnicity Aldol condensation (n, %) African 52 (1.6) 5 (1.4) 57 (1.5) Asian 10 (0.3) 1 (0.3) 11 (0.3) Caucasian 2,942 (87.8) 340 (92.1) 3,282 (88.2) East Asian 25 (0.7) 4 (1.1) 29 (0.8) Hispanic 302 (9.0) 19 (5.1) 321 (8.6) Other 18 (0.5) 0 (0.0)
18 (0.5) Lumbar spine T-score (mean, SD) −2.51 (1.36)** −2.21 (1.57) −2.48 (1.38) Femoral neck T-score (mean, SD) −2.45 (0.92) −2.35 (0.91) −2.44 (0.92) Total hip T-score (mean, SD) −2.20 (1.00)** −1.97 (0.96) −2.18 (0.99) Prior fragility fracture (% yes) 56.7 59.1 57.0 Prior osteoporosis therapy (% yes)b 88.4*** 61.5 85.7 Patients with comorbid conditions (% yes)c 83.1 83.5 83.1 Number of comorbid conditions (mean, SD) 1.79 (1.41) 1.91 (1.51) 1.80 (1.42) Family history of osteoporosis (% yes) 39.8*** 28.5 38.6 Smoking (% yes) 12.8 16.8* 13.2 Alcohol use (% yes) 24.8 33.6*** 25.7 Caffeine (% yes) 71.2 71.3 71.2 DANCE Direct Assessment of Nonvertebral Fractures in Community Experience, SD standard deviation *p < 0.05; **p < 0.01; ***p ≤ 0.