We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Further Nonvertebral Fracture Reduction Beyond 3 Years for Up to 10 Years of Denosumab Treatment.
- Authors
Ferrari, Serge; Butler, Peter W; Kendler, David L; Miller, Paul D; Roux, Christian; Wang, Andrea T; Huang, Shuang; Wagman, Rachel B; Lewiecki, E Michael
- Abstract
<bold>Context: </bold>Evidence for further nonvertebral fracture (NVF) reductions with long-term antiresorptive therapy in osteoporosis is lacking.<bold>Objective: </bold>To evaluate NVF risk reduction in subjects receiving ≤10 years of denosumab treatment.<bold>Design: </bold>Phase 3, randomized, placebo-controlled, 3-year Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial (NCT00089791) and its open-label 7-year extension (NCT00523341).<bold>Setting: </bold>One hundred seventy-two study centers worldwide.<bold>Patients: </bold>Women 60 to 90 years, lumbar spine or total hip bone mineral density T-scores <-2.5 (≥-4.0 at both).<bold>Interventions: </bold>Subjects randomly assigned 1:1 denosumab 60 mg SC Q6M (long-term) or placebo (crossover) in FREEDOM; eligible subjects could enroll in the extension to receive denosumab 60 mg SC Q6M.<bold>Main Outcome Measures: </bold>NVF Exposure-adjusted subject incidence (per 100 subject-years) during denosumab treatment years 1 to 3 and 4 to 7 (all subjects) and years 4 to 10 (long-term only), and rate ratios (RRs) for years 4 to 7 or 4 to 10 vs 1 to 3.<bold>Results: </bold>Among 4074 subjects (2343 long-term, 1731 crossover), NVF rates (95% CI) in all subjects were 2.15 (1.90 to 2.43) during years 1 to 3 and 1.53 (1.34 to 1.75) during years 4 to 7 of denosumab treatment [RR (95% CI) = 0.72 (0.61 to 0.86); P < 0.001]; in long-term only were 1.98 (1.67 to 2.34) during years 1 to 3 and 1.44 (1.24 to 1.66) during years 4 to 10 [RR = 0.74 (0.60 to 0.93); P = 0.008]. combined osteonecrosis of the jaw and atypical femoral fracture rate was 0.06.<bold>Conclusions: </bold>Long-term denosumab treatment, >3 and ≤10 years, was associated with further reductions in NVF rates compared with the first 3 years.
- Publication
Journal of Clinical Endocrinology & Metabolism, 2019, Vol 104, Issue 8, p3450
- ISSN
0021-972X
- Publication type
journal article
- DOI
10.1210/jc.2019-00271