CONTEXT: The FREEDOM (Fracture REduction Evaluation of Denosumab in @entity170 every 6 Months) trial showed denosumab significantly reduced the risk of @entity174 in postmenopausal @entity1 with @entity170 . OBJECTIVE: We evaluated the effect of denosumab on the incidence of new vertebral and @entity173 in subgroups of @entity1 at higher risk for these @entity174 . DESIGN: FREEDOM was a 3-yr, randomized, double-blind, placebo-controlled, phase 3 trial. @entity1 AND SETTING: Postmenopausal @entity1 (N = 7808) with @entity170 were enrolled at 213 study sites worldwide. INTERVENTIONS: Subjects received s.c. denosumab (60 mg) or placebo every 6 months and daily supplements of @entity460 (>= 1000 mg) and @entity560 (>= 400 IU). MAIN OUTCOME MEASURES: This post hoc analysis evaluated @entity174 incidence in @entity1 with known risk factors for @entity174 including multiple and/or moderate or severe prevalent @entity174 , aged 75 yr or older, and/or femoral neck bone mineral density T-score of -2.5 or less. RESULTS: Compared with placebo, denosumab significantly reduced the risk of new @entity174 in @entity1 with multiple and/or severe prevalent @entity174 (16.6% placebo vs. 7.5% denosumab; P < 0.001). Similarly, denosumab significantly reduced the risk of @entity173 in subjects aged 75 yr or older (2.3% placebo vs. 0.9% denosumab; P < 0.01) or with a baseline femoral neck bone mineral density T-score of -2.5 or less (2.8% placebo vs. 1.4% denosumab; P = 0.02). These risk reductions in higher-risk individuals were consistent with those seen in @entity1 at lower risk of @entity174 . CONCLUSIONS: Denosumab reduced the incidence of new vertebral and @entity173 in postmenopausal @entity1 with @entity170 at higher risk for @entity174 . These results highlight the consistent antifracture efficacy of denosumab in @entity1 with varying degrees of @entity174 risk.

Treatment with denosumab reduces the incidence of new vertebral and @entity173 in postmenopausal XXXX at high risk.

@entity1 :: ('9606', 'Species') :: ['women', 'patients', 'PARTICIPANTS'] @entity174 :: ('MESH:D050723', 'Disease') :: ['fractures', 'fracture', 'vertebral fractures'] @entity170 :: ('MESH:D010024', 'Disease') :: ['Osteoporosis', 'osteoporosis'] @entity173 :: ('MESH:D006620', 'Disease') :: ['hip fractures'] @entity460 :: ('MESH:D002118', 'Chemical') :: ['calcium'] @entity560 :: ('MESH:D014807', 'Chemical') :: ['vitamin D']
@entity1 :: (9606,Species) :: ['women']
