Akimitsu Miyauchi1, Etsuro Hamaya2, Kiyoshi Nishi3, Cae Tolman4, Junichiro Shimauchi3. 1. Miyauchi Medical Center, Osaka, Japan. 2. Amgen K.K., Midtown Tower 9-7-1, Akasaka Minato-ku, Tokyo, 107-6239, Japan. ehamaya@amgen.com. 3. Amgen K.K., Midtown Tower 9-7-1, Akasaka Minato-ku, Tokyo, 107-6239, Japan. 4. Amgen Asia, Hong Kong, China.
Abstract
INTRODUCTION: This post hoc analysis of the placebo-controlled phase 3 FRAME study assessed the efficacy and safety of romosozumab in a subpopulation of Japanese postmenopausal women with osteoporosis and chronic kidney disease (CKD). MATERIALS AND METHODS: Data were analyzed by baseline estimated glomerular filtration rate (eGFR), where < 90 mL/min/1.73 m2 denoted CKD and ≥ 90 mL/min/1.73 m2 indicated normal renal function. Efficacy outcomes included percent change in lumbar spine, total hip, and femoral neck bone mineral density (BMD) at 12 months from baseline (primary) and incidence of new vertebral and non-vertebral fractures. Tolerability was also assessed. RESULTS: Of 489 Japanese patients with available eGFR data, 339 had mild-to-moderate CKD (romosozumab, n = 170; placebo, n = 169) and 150 had normal renal function (romosozumab, n = 75; placebo, n = 75). Compared with placebo, romosozumab increased lumbar spine BMD by 14.8% (95% confidence interval [CI] 13.7-15.9) and 15.2% (95% CI 13.4-16.9) in the eGFR < 90 and ≥ 90 mL/min/1.73 m2 subgroups, total hip BMD by 4.6% (95% CI 3.8-5.4) and 5.5% (95% CI 4.4-6.7), and femoral neck BMD by 4.0% (95% CI 2.9-5.2) and 5.5% (95% CI 3.8-7.1) at 12 months, respectively (all p < 0.001 vs. placebo). New vertebral fracture incidence was numerically lower with romosozumab than placebo at 12 months in both eGFR subgroups, while the incidence of adverse events was similar between subgroups. CONCLUSION: Romosozumab for 12 months is an effective and well-tolerated treatment option for Japanese patients with osteoporosis and mild-to-moderate CKD.
INTRODUCTION: This post hoc analysis of the placebo-controlled phase 3 FRAME study assessed the efficacy and safety of romosozumab in a subpopulation of Japanese postmenopausal women with osteoporosis and chronic kidney disease (CKD). MATERIALS AND METHODS: Data were analyzed by baseline estimated glomerular filtration rate (eGFR), where < 90 mL/min/1.73 m2 denoted CKD and ≥ 90 mL/min/1.73 m2 indicated normal renal function. Efficacy outcomes included percent change in lumbar spine, total hip, and femoral neck bone mineral density (BMD) at 12 months from baseline (primary) and incidence of new vertebral and non-vertebral fractures. Tolerability was also assessed. RESULTS: Of 489 Japanese patients with available eGFR data, 339 had mild-to-moderate CKD (romosozumab, n = 170; placebo, n = 169) and 150 had normal renal function (romosozumab, n = 75; placebo, n = 75). Compared with placebo, romosozumab increased lumbar spine BMD by 14.8% (95% confidence interval [CI] 13.7-15.9) and 15.2% (95% CI 13.4-16.9) in the eGFR < 90 and ≥ 90 mL/min/1.73 m2 subgroups, total hip BMD by 4.6% (95% CI 3.8-5.4) and 5.5% (95% CI 4.4-6.7), and femoral neck BMD by 4.0% (95% CI 2.9-5.2) and 5.5% (95% CI 3.8-7.1) at 12 months, respectively (all p < 0.001 vs. placebo). New vertebral fracture incidence was numerically lower with romosozumab than placebo at 12 months in both eGFR subgroups, while the incidence of adverse events was similar between subgroups. CONCLUSION: Romosozumab for 12 months is an effective and well-tolerated treatment option for Japanese patients with osteoporosis and mild-to-moderate CKD.