Motohiko Sato1, Masaaki Inaba2, Shinsuke Yamada3, Masanori Emoto3, Yoshiteru Ohno4, Yoshihiro Tsujimoto5. 1. Department of Orthopedics, Inoue Hospital, Osaka, Japan. 2. Renal Center, Ohno Memorial Hospital, 1-26-10, Minami-Horie, Nishi-ku, Osaka, Osaka, 550-0015, Japan. m-inaba@ohno.or.jp. 3. Department of Metabolism, Endocrinology, and Molecular Medicine, Osaka City University Medical School, Osaka, Japan. 4. Renal Center, Ohno Memorial Hospital, 1-26-10, Minami-Horie, Nishi-ku, Osaka, Osaka, 550-0015, Japan. 5. Renal Center, Inoue Hospital, Osaka, Japan.
Abstract
INTRODUCTION: Romosozumab reportedly increases bone mineral density (BMD) potently but might adversely affect cardiovascular disease (CVD). We evaluated the efficacy of romosozumab in osteoporotic HD patients with a high risk of fracture. MATERIALS AND METHODS: This was a single-center 1-year study in Japanese HD patients. Among 96 HD romosozumab-treated HD patients with high risk of fracture, 76 HD patients completed 1 year of subcutaneous administration of romosozumab (210 mg/4 weeks) for 1 year. Romosozumab-untreated HD patients (n = 55) were also included. Changes in BMD and serum markers, together with fracture occurrence, and CVD events, were monitored. RESULTS: During romosozumab treatment of 76 HD patients, BMD time-dependently increased significantly by 15.3% ± 12.9% at the lumbar spine (L1-4), and 7.2% ± 8.3% at the femoral neck at 1 year. Serum BAP and total P1NP increased significantly and serum TRACP-5b decreased at 4 weeks. Fragility fractures occurred in three (3.8%) patients. Hypocalcemia occurred at 4-48 weeks despite the increased dosing of active vitamin-D derivatives, but without any symptom. New CVD events occurred in 5.2% of romosozumab-treated HD patients and10.9% in romosozumab-untreated HD patients. CONCLUSIONS: BMD was increased significantly during romosozumab treatment at the lumbar spine, and the femoral neck, respectively, at 1 year in HD patients. Hypocalcemia occurred but without any intolerable event. There was no apparent increase in CVD events during 1 year of study, suggesting romosozumab as a promising agent for HD patients with severe osteoporosis.
INTRODUCTION:Romosozumab reportedly increases bone mineral density (BMD) potently but might adversely affect cardiovascular disease (CVD). We evaluated the efficacy of romosozumab in osteoporotic HDpatients with a high risk of fracture. MATERIALS AND METHODS: This was a single-center 1-year study in Japanese HDpatients. Among 96 HDromosozumab-treated HDpatients with high risk of fracture, 76 HDpatients completed 1 year of subcutaneous administration of romosozumab (210 mg/4 weeks) for 1 year. Romosozumab-untreated HDpatients (n = 55) were also included. Changes in BMD and serum markers, together with fracture occurrence, and CVD events, were monitored. RESULTS: During romosozumab treatment of 76 HDpatients, BMD time-dependently increased significantly by 15.3% ± 12.9% at the lumbar spine (L1-4), and 7.2% ± 8.3% at the femoral neck at 1 year. Serum BAP and total P1NP increased significantly and serum TRACP-5b decreased at 4 weeks. Fragility fractures occurred in three (3.8%) patients. Hypocalcemia occurred at 4-48 weeks despite the increased dosing of active vitamin-D derivatives, but without any symptom. New CVD events occurred in 5.2% of romosozumab-treated HDpatients and10.9% in romosozumab-untreated HDpatients. CONCLUSIONS: BMD was increased significantly during romosozumab treatment at the lumbar spine, and the femoral neck, respectively, at 1 year in HDpatients. Hypocalcemia occurred but without any intolerable event. There was no apparent increase in CVD events during 1 year of study, suggesting romosozumab as a promising agent for HDpatients with severe osteoporosis.
Authors: M Abdalbary; M Sobh; S Elnagar; M A Elhadedy; N Elshabrawy; M Abdelsalam; K Asadipooya; A Sabry; A Halawa; A El-Husseini Journal: Osteoporos Int Date: 2022-06-24 Impact factor: 5.071
Authors: Mathias Haarhaus; Giuseppe Cianciolo; Simona Barbuto; Gaetano La Manna; Lorenzo Gasperoni; Giovanni Tripepi; Mario Plebani; Maria Fusaro; Per Magnusson Journal: Nutrients Date: 2022-05-19 Impact factor: 6.706