Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease

Oxford University Press (OUP) - Tập 37 Số 8 - Trang 1437-1445 - 2020
Paul D. Miller1, Jonathan D. Adachi2, Ben‐Hur Albergaria3, Angela M. Cheung4, Arkadi Chines5, Evelien Gielen6, Bente Langdahl7, Akimitsu Miyauchi8, Mary Oates5, Ian R. Reid9, Norma Ruiz Santiago5, Mark Vanderkelen10, Zhenxun Wang5, Zhigang Yu5
1Colorado Center for Bone Health Lakewood CO USA
2St. Joseph’s Healthcare Hamilton, McMaster University, Hamilton, Canada
3Federal University of Espirito Santo, Espirito Santo Research and Osteoporosis Center Vitória Brazil
4Department of Medicine, University Health Network, University of Toronto, Toronto, Canada
5Amgen Inc., Thousand Oaks, CA USA
6Gerontology and Geriatrics, Department of Public Health and Primary Care KU Leuven & Center for Metabolic Bone Diseases, UZ Leuven Leuven Belgium
7Aarhus University Hospital, Aarhus, Denmark
8Miyauchi Medical Center, Osaka, Japan
9University of Auckland, Auckland, New Zealand
10UCB S.A., Brussels, Belgium

Tóm tắt

ABSTRACT Patients with osteoporosis and chronic kidney disease (CKD) are at increased risk of fracture and associated negative outcomes, including increased mortality. The present post hoc analysis of two randomized, multicenter, phase 3 clinical trials—Fracture Study in Postmenopausal Women with Osteoporosis (FRAME) and Active-Controlled Fracture Study in Postmenopausal Women with Osteoporosis at High Risk (ARCH)—investigated the efficacy and safety of romosozumab in postmenopausal women with osteoporosis and mild-to-moderate CKD. The analysis included data from 7147 patients from FRAME and 4077 from ARCH. Eighty-one percent of patients from FRAME and 85% from ARCH had mild or moderate reduction in estimated glomerular filtration rate (eGFR) at baseline, and part of this reduction is likely age related. During the 1-year double-blind phases of the trials, patients received romosozumab 210 mg sc or placebo monthly in FRAME and romosozumab 210 mg sc monthly or alendronate 70 mg po weekly in ARCH. Bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck and vertebral and nonvertebral fractures were assessed at baseline and month 12. In both trials, the least-square mean percent change from baseline BMD was significantly greater in the romosozumab groups versus controls across all kidney function categories at month 12. Romosozumab reduced the relative risk of new vertebral fractures at month 12 among patients with eGFR of 30–59, 60–89, and ≥90 mL/min by 72% (95% confidence interval [CI] 14–91; p = 0.017), 70% (40–85; p < 0.001), and 84% (30–96; p = 0.005), respectively, in FRAME versus placebo, and by 51% (5–75; p = 0.04), 19% (−28 to 49; p = 0.39), and 57% (1–81, p = 0.04), respectively, in ARCH versus alendronate. Incidences of adverse events, asymptomatic decreases in serum calcium, and evolution of kidney function during the studies were similar across all baseline kidney function groups. Romosozumab is an effective treatment option for postmenopausal women with osteoporosis and mild-to-moderate reduction in kidney function, with a similar safety profile across different levels of kidney function. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

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Oxford University Press (OUP)

Tập 37 Số 8

1437-1445

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