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Tytuł pozycji:

Long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis: 3-year post-marketing surveillance study.

Tytuł:
Long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis: 3-year post-marketing surveillance study.
Autorzy:
Tanaka S; Department of Orthopaedic Surgery, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Mizutani H; Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan. .
Tsuruya E; Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
Fukuda R; Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
Kuge K; Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
Okubo N; Biostatistics and Data Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Źródło:
Journal of bone and mineral metabolism [J Bone Miner Metab] 2021 May; Vol. 39 (3), pp. 463-473. Date of Electronic Publication: 2021 Jan 02.
Typ publikacji:
Journal Article; Observational Study
Język:
English
Imprint Name(s):
Original Publication: Tokyo : Japanese Society of Bone and Mineral Metabolism, [1988-
MeSH Terms:
Asian People*
Product Surveillance, Postmarketing*
Denosumab/*adverse effects
Denosumab/*therapeutic use
Osteoporosis/*drug therapy
Aged ; Biomarkers/metabolism ; Bone Density/drug effects ; Bone Density Conservation Agents/pharmacology ; Bone Density Conservation Agents/therapeutic use ; Bone Remodeling/drug effects ; Female ; Humans ; Hypocalcemia/epidemiology ; Incidence ; Japan ; Male ; Multivariate Analysis ; Osteoporosis/physiopathology ; Osteoporotic Fractures/drug therapy ; Osteoporotic Fractures/physiopathology ; Prospective Studies ; Time Factors ; Treatment Outcome
References:
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Contributed Indexing:
Keywords: Denosumab; Hypocalcaemia; Japanese; Osteoporosis; Real-world survey
Substance Nomenclature:
0 (Biomarkers)
0 (Bone Density Conservation Agents)
4EQZ6YO2HI (Denosumab)
Entry Date(s):
Date Created: 20210102 Date Completed: 20210513 Latest Revision: 20221207
Update Code:
20240105
DOI:
10.1007/s00774-020-01180-4
PMID:
33387064
Czasopismo naukowe
Introduction: Denosumab is a humanized IgG2 monoclonal antibody that was approved for the treatment of osteoporosis in Japan in 2013. This study aimed to investigate the long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis in daily clinical practice.
Materials and Methods: This 3-year, prospective, observational, post-marketing study included patients who initiated treatment with denosumab (60 mg/6 months) for osteoporosis. Data were assessed at baseline, 3, 6, 12, 24 and 36 months. Key endpoints were adverse events (AEs), adverse drug reactions (ADRs), occurrence of osteoporotic fractures, bone mineral density (BMD), and bone turnover markers. Multivariate analyses were conducted to identify predictors of hypocalcaemia and percent change in BMD.
Results: Overall, 3534 patients were assessed (mean 75.7 years; 89.8% women). In total, 298 patients (8.4%) developed ADRs; the most common was hypocalcaemia (3.9%). Hypocalcaemia risk was significantly increased in patients with creatinine clearance < 30 mL/min, no prior use of bisphosphonates, prior use of calcium and vitamin D preparations, baseline serum calcium < 8.5 mg/dL, and no concomitant use of calcium or vitamin D preparations. Six patients had adjudicated osteonecrosis of the jaw. Lumbar spine BMD increased significantly from baseline (mean percent change: 11.4% at 36 months). All bone turnover markers decreased significantly from baseline. Over 3 years, 3.3% of patients developed a new osteoporotic fracture.
Conclusions: This study confirmed the long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis in daily clinical practice. No new safety signals were identified.

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