PMID- 33387064
OWN - NLM
STAT- MEDLINE
DCOM- 20210513
LR  - 20221207
IS  - 1435-5604 (Electronic)
IS  - 0914-8779 (Linking)
VI  - 39
IP  - 3
DP  - 2021 May
TI  - Long-term safety and effectiveness of denosumab in Japanese patients with 
      osteoporosis: 3-year post-marketing surveillance study.
PG  - 463-473
LID - 10.1007/s00774-020-01180-4 [doi]
AB  - 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.
FAU - Tanaka, Sakae
AU  - Tanaka S
AUID- ORCID: 0000-0001-9210-9414
AD  - Department of Orthopaedic Surgery, Graduate School of Medicine, The University of 
      Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
FAU - Mizutani, Hideki
AU  - Mizutani H
AD  - Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi 
      Honcho, Chuo-ku, Tokyo, 103-8426, Japan. mizutani.hideki.m5@daiichisankyo.co.jp.
FAU - Tsuruya, Eri
AU  - Tsuruya E
AD  - Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi 
      Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
FAU - Fukuda, Ryoko
AU  - Fukuda R
AD  - Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi 
      Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
FAU - Kuge, Kiyoka
AU  - Kuge K
AD  - Post Marketing Study Department, Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi 
      Honcho, Chuo-ku, Tokyo, 103-8426, Japan.
FAU - Okubo, Naoki
AU  - Okubo N
AUID- ORCID: 0000-0001-5665-3981
AD  - Biostatistics and Data Management Department, Daiichi Sankyo Co., Ltd., Tokyo, 
      Japan.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20210102
PL  - Japan
TA  - J Bone Miner Metab
JT  - Journal of bone and mineral metabolism
JID - 9436705
RN  - 0 (Biomarkers)
RN  - 0 (Bone Density Conservation Agents)
RN  - 4EQZ6YO2HI (Denosumab)
SB  - IM
MH  - Aged
MH  - *Asian People
MH  - Biomarkers/metabolism
MH  - Bone Density/drug effects
MH  - Bone Density Conservation Agents/pharmacology/therapeutic use
MH  - Bone Remodeling/drug effects
MH  - Denosumab/*adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Hypocalcemia/epidemiology
MH  - Incidence
MH  - Japan
MH  - Male
MH  - Multivariate Analysis
MH  - Osteoporosis/*drug therapy/physiopathology
MH  - Osteoporotic Fractures/drug therapy/physiopathology
MH  - *Product Surveillance, Postmarketing
MH  - Prospective Studies
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Denosumab
OT  - Hypocalcaemia
OT  - Japanese
OT  - Osteoporosis
OT  - Real-world survey
EDAT- 2021/01/03 06:00
MHDA- 2021/05/14 06:00
CRDT- 2021/01/02 12:08
PHST- 2020/03/04 00:00 [received]
PHST- 2020/11/04 00:00 [accepted]
PHST- 2021/01/03 06:00 [pubmed]
PHST- 2021/05/14 06:00 [medline]
PHST- 2021/01/02 12:08 [entrez]
AID - 10.1007/s00774-020-01180-4 [pii]
AID - 10.1007/s00774-020-01180-4 [doi]
PST - ppublish
SO  - J Bone Miner Metab. 2021 May;39(3):463-473. doi: 10.1007/s00774-020-01180-4. Epub 
      2021 Jan 2.