In the alendronate MLN8237 datasheet sodium-treated cohort, the incidence of VTE was 7.2 per 1,000 PY and the
HRs were 1.10 (95% CI, 0.81–1.50] and 0.92 (95% CI, 0.63–1.33) in age-adjusted and fully adjusted models, respectively, versus untreated osteoporotic women. The rate of mortality was similar for both cohorts, which are 2.9% in the strontium LY2874455 mw ranelate group and 4.0% in the alendronate group. Table 3 Incidence of VTE in osteoporotic patients treated with strontium ranelate or alendronate sodium versus untreated osteoporotic patients Treated osteoporotic patients Untreated osteoporotic patients (N = 11,546) Strontium ranelate (N = 2,408) Alendronate sodium (N = 20,084) Patients with VTE (N) 13 140 61 Annual incidence (per 1,000 PY) 7.0 7.2 5.6 Adjusted model
on agea HR (SE) 1.15 (0.31) 1.10 (0.16) 95% CI 0.63–2.10 0.81–1.50 p value 0.656 0.530 Fully adjustedb HR (SE) 1.09 (0.31) 0.92 (0.19) 95% CI 0.60–2.01) 0.63–1.33) p value 0.773 0.646 VTE venous thromboembolism YH25448 in vivo (including deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis, CI confidence interval, HR hazard ratio, SE standard error, PY patients–years aHR between groups based on a Cox proportional hazards regression model adjusted on age bHR between groups based on a Cox proportional hazards regression model fully adjusted for all confounders described in the Methods section (final
regression model by backward selection) Sensitivity analyses were performed within each cohort of treated osteoporotic patients (Table 4). The incidence of VTE during drug exposure (current users) was compared Non-specific serine/threonine protein kinase with the incidence when not exposed either before the beginning of the treatment or after treatment cessation (non-users). No significant difference in the incidence of VTE was observed between the current users and non-users of strontium ranelate (6.8 versus 7.0 per 1,000 PY; HR, 0.90 [95% CI, 0.46–1.75]); similar results were obtained with alendronate sodium (6.2 versus 7.2 per 1,000 PY; HR, 0.99 [95% CI, 0.80–1.23]). Table 4 Incidence of VTE in current users versus non-users of strontium ranelate or alendronate sodium Treated osteoporotic patients Strontium ranelate (N = 2,408) Alendronate sodium (N = 20,084) Non-users Current users Non-users Current users Patients with VTE (N) 34 13 230 140 Annual incidence (per 1,000 PY) 6.8 7.0 6.2 7.2 HR (SE)a 0.90 (0.34) 0.99 (0.11) 95% CI 0.46–1.75 0.80–1.23 p value 0.75 0.