2 Incidence of NVFX during treatment with TPTD and after treatment cessation. Incidence = number of patients with new NVFX/number of patients at risk × 100 Fracture sites included, #PI3K inhibitor randurls[1|1|,|CHEM1|]# in decreasing

order of frequency, the distal forearm (n = 21), foot/toes (n = 20), hip (n = 16), rib (n = 14), “other” sites (n = 14), leg (n = 9), hand/fingers (n = 7), pelvis (n = 7), knee (n = 7), ankle (n = 6), humerus (n = 3), shoulder (n = 2), skull (n = 1), breastbone (n = 0), and clavicle (n = 0). “Other” sites were not specifically identified by patients but were considered sites other than the following: ankle, arm (humerus), breast bone (sternum), collarbone (clavicle), distal forearm (wrist), foot/toes, hand/fingers, hip, knee, leg,

pelvis, ribs, shoulder, skull, spine L1-L4, and spine T4-T12. Most fractures were either self-reported or confirmed by x-ray report. The incidence of fractures was not compared by type of fracture or whether fractures were self-reported versus radiologically confirmed due to the small sample sizes in the subgroups. Many osteoporosis studies exclude fractures of fingers and SIS3 mouse toes in the NVFX analysis. We performed an additional analysis that excluded foot/toes, hand/fingers, and “other sites” (which was a separate category). The findings were very similar to those reported, which included all NVFXs (data for additional analysis not shown). When the efficacy population was analyzed by gender (Table 3), the incidence of new NVFX in women was significantly lower for each of the three later treatment periods compared with the >0 to ≤6 months reference period (each p < 0.05), while significant differences did not emerge in any group for the men. However, there were only a small number of fracture events (n = 6) in the male cohort, which may have

limited the ability to detect differences. Table 3 Incidence of nonvertebral fragility fractures by gender during the treatment phase Duration (months) Gender Number of patients with new NVFX Number of patients at risk Incidence (95 % selleck inhibitor CI)a >0 to ≤6 Female 50 3,350 1.49 (1.11, 1.96) Male 3 369 0.81 (0.17, 2.36) >6 to ≤12 Female 25 2,665 0.94* (0.61, 1.38) Male 2 305 0.66 (0.08, 2.35) >12 to ≤18 Female 17 2,306 0.74** (0.43, 1.18) Male 1 264 0.38 (0.01, 2.09) >18 to ≤24 Female 18 2,003 0.90* (0.53, 1.42) Male 0 222 0.00 (0.00, 1.65) NVFX nonvertebral fragility fractures *p < 0.05; **p < 0.01 compared to the incidence rate from >0 to ≤6 months (reference period) aIncidence = number of patients with NVFX/total patients at risk × 100 As shown in Table 4, a significantly greater percentage of patients who reported a new NVFX had a prior fragility fracture compared to patients with no new fracture.