PMID- 35041084
OWN - NLM
STAT- MEDLINE
DCOM- 20220311
LR  - 20220531
IS  - 1435-5604 (Electronic)
IS  - 0914-8779 (Linking)
VI  - 40
IP  - 2
DP  - 2022 Mar
TI  - Long-term safety of eldecalcitol in Japanese patients with osteoporosis: a 
      retrospective, large-scale database study.
PG  - 275-291
LID - 10.1007/s00774-021-01276-5 [doi]
AB  - INTRODUCTION: This real-world study evaluated whether long-term use of 
      eldecalcitol (ELD) increases the risk of adverse events (AEs), namely, 
      hypercalcemia, acute kidney injury (AKI), and urolithiasis, and analyzed the 
      ELD-induced risk of rare AEs such as osteonecrosis of the jaw (ONJ) and atypical 
      femoral fracture (AFF). MATERIALS AND METHODS: Patient records were retrieved 
      from Medical Data Vision (MDV) and Japan Medical Data Center (JMDC) databases. 
      The ELD-treated osteoporosis patient cohort (ELD cohort) was analyzed to 
      determine the incidence rate of the aforementioned AEs. The patient cohort that 
      was prescribed active vitamin D(3) other than ELD (AVD cohort) was analyzed as 
      the reference. RESULTS: Incidence rates of hypercalcemia, AKI, and urolithiasis 
      in the ELD cohort were 0.942, 0.517, 2.465 events per 100 person-years, 
      respectively, in the MDV dataset, and 0.687, 0.155, 3.785, respectively, in the 
      JMDC dataset. The incidence rates of these AEs in the ELD cohort remained 
      relatively constant throughout ELD treatment. A small number of patients 
      experienced ONJ or AFF during ELD or AVD treatment. The number of ONJ and AFF 
      cases in the both cohorts decreased over time. The two cohorts showed no 
      difference in the concomitant use of anti-bone resorptive agents such as 
      bisphosphonates and denosumab. CONCLUSION: The risk of hypercalcemia and AKI 
      associated with ELD use observed in this retrospective analysis is similar to 
      that reported previously in the Japanese post-marketing surveillance of ELD. 
      Furthermore, ELD, similar to AVD, may not increase the risk of ONJ and AFF.
CI  - (c) 2022. The Japanese Society Bone and Mineral Research.
FAU - Takeuchi, Yasuhiro
AU  - Takeuchi Y
AD  - Endocrine Center, Toranomon Hospital, Minato-ku, Tokyo, Japan.
AD  - Okinaka Memorial Medical Research, Minato-ku, Tokyo, Japan.
FAU - Saito, Hitoshi
AU  - Saito H
AD  - Chugai Pharmaceutical Co. Ltd, 2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo, 
      103-8324, Japan. saitohts@chugai-pharm.co.jp.
FAU - Makishima, Misako
AU  - Makishima M
AD  - Chugai Pharmaceutical Co. Ltd, 2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo, 
      103-8324, Japan.
FAU - Yokoyama, Hiroko
AU  - Yokoyama H
AD  - Chugai Pharmaceutical Co. Ltd, 2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo, 
      103-8324, Japan.
FAU - Yamaguchi, Tomohiro
AU  - Yamaguchi T
AD  - Chugai Pharmaceutical Co. Ltd, 2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo, 
      103-8324, Japan.
FAU - Fujii, Hiroyuki
AU  - Fujii H
AD  - Intage Healthcare Inc, Chiyoda-ku, Tokyo, Japan.
FAU - Inoue, Eri
AU  - Inoue E
AD  - Intage Healthcare Inc, Chiyoda-ku, Tokyo, Japan.
FAU - Isemura, Tomoya
AU  - Isemura T
AD  - Intage Healthcare Inc, Chiyoda-ku, Tokyo, Japan.
FAU - Kondo, Satoshi
AU  - Kondo S
AD  - Chugai Pharmaceutical Co. Ltd, 2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo, 
      103-8324, Japan.
LA  - eng
PT  - Journal Article
DEP - 20220118
PL  - Japan
TA  - J Bone Miner Metab
JT  - Journal of bone and mineral metabolism
JID - 9436705
RN  - 0 (Bone Density Conservation Agents)
RN  - 0 (Diphosphonates)
RN  - 1406-16-2 (Vitamin D)
RN  - I2JP8UE90H (eldecalcitol)
SB  - IM
MH  - Acute Kidney Injury/chemically induced
MH  - Bisphosphonate-Associated Osteonecrosis of the Jaw
MH  - *Bone Density Conservation Agents/adverse effects
MH  - Diphosphonates/adverse effects
MH  - Femoral Fractures
MH  - Humans
MH  - Hypercalcemia/chemically induced
MH  - Japan/epidemiology
MH  - *Osteoporosis/drug therapy/epidemiology
MH  - Retrospective Studies
MH  - Urolithiasis/chemically induced
MH  - *Vitamin D/adverse effects/analogs & derivatives
OTO - NOTNLM
OT  - Adverse events
OT  - Atypical femoral fracture
OT  - Osteonecrosis of the jaw
OT  - Osteoporosis
OT  - Real-world database study
EDAT- 2022/01/19 06:00
MHDA- 2022/03/12 06:00
CRDT- 2022/01/18 12:36
PHST- 2021/05/31 00:00 [received]
PHST- 2021/09/27 00:00 [accepted]
PHST- 2022/01/19 06:00 [pubmed]
PHST- 2022/03/12 06:00 [medline]
PHST- 2022/01/18 12:36 [entrez]
AID - 10.1007/s00774-021-01276-5 [pii]
AID - 10.1007/s00774-021-01276-5 [doi]
PST - ppublish
SO  - J Bone Miner Metab. 2022 Mar;40(2):275-291. doi: 10.1007/s00774-021-01276-5. Epub 
      2022 Jan 18.