Further reductions in nonvertebral fracture rate with long-term denosumab treatment in the FREEDOM open-label extension and influence of hip XXXX after 3  years.

@entity1 @entity79 @entity170 @entity174
UNASSIGNED: Limited data exist on the efficacy of long-term therapies for @entity170 . In osteoporotic postmenopausal @entity1 receiving denosumab for 7  years, nonvertebral fracture rates significantly decreased in years 4-7 versus years 1-3. This is the first demonstration of a further benefit on fracture outcomes with long-term therapy for @entity170 . INTRODUCTION: This study aimed to evaluate whether denosumab treatment continued beyond 3  years is associated with a further reduction in nonvertebral fracture rates. METHODS: @entity1 who completed the 3-year placebo-controlled @entity174 REduction Evaluation of Denosumab in @entity170 every 6 Months (FREEDOM) study were invited to participate in an open-label extension. The present analysis includes 4,074 postmenopausal @entity1 with @entity170 (n   =   2,343 long-term; n   =   1,731 cross-over) who enrolled in the extension, missed  <=1 dose during their first 3  years of denosumab treatment, and continued into the fourth year of treatment. Comparison of nonvertebral fracture rates during years 1-3 of denosumab with that of the fourth year and with the rate during years 4-7 was evaluated. RESULTS: For the combined group, the nonvertebral fracture rate per 100 @entity1 -years was 2.15 for the first 3  years of denosumab treatment (referent) and 1.36 in the fourth year (rate ratio [RR]   =   0.64; 95  % confidence interval (CI)   =   0.48 to 0.85, p   =   0.003). Comparable findings were observed in the groups separately and when nonvertebral fracture rates during years 1-3 were compared to years 4-7 in the long-term group (RR   =   0.79; 95  % CI   =   0.62 to 1.00, p   =   0.046). @entity174 rate reductions in year 4 were most prominent in subjects with persisting low hip @entity79 ( @entity79 ). CONCLUSIONS: Denosumab treatment beyond 3  years was associated with a further reduction in nonvertebral fracture rate that persisted through 7  years of continuous denosumab administration. The degree to which denosumab further reduces nonvertebral fracture risk appears influenced by the hip bone density achieved with initial therapy.
