PMID- 34755007
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240404
IS  - 2475-0328 (Electronic)
IS  - 2475-0328 (Linking)
VI  - 5
IP  - 6
DP  - 2021 Nov
TI  - Utility of monthly minodronate for osteoporosis after gastrectomy: Prospective 
      multicenter randomized controlled trials.
PG  - 754-766
LID - 10.1002/ags3.12474 [doi]
AB  - AIM: Osteoporosis in patients after gastrectomy is increasing with the aging of 
      gastric cancer patients. Bisphosphonates are effective treatments for 
      osteoporosis; however, their safety or efficacy in postgastrectomy patients has 
      not been established. The purpose of this multicenter prospective intervention 
      study was to investigate the impact of monthly minodronate on osteoporosis after 
      gastrectomy. METHODS: Of the 261 enrolled gastric cancer patients, 164 patients 
      were diagnosed with osteoporosis based on criteria of the Japan Society of 
      Osteoporosis. They were randomly assigned 1:1 to groups treated with active 
      vitamin D (VD group) or monthly minodronate (MIN group). The primary endpoint was 
      changes in lumbar bone mineral density (L-BMD) 12 mo after the start of 
      administration. The secondary endpoints were changes in bone metabolism markers, 
      adverse events (AEs), or treatment completion rates. RESULTS: There was no 
      significant difference in patient background between the VD (n = 82) and MIN 
      (n = 82) groups. In the MIN group, the increase in L-BMD was significantly higher 
      than that in the VD group (4.52% vs 1.72%, P = .001), with a significant 
      reduction in bone metabolism markers; blood NTX (-25.6% vs -1.6%, P < .01) and 
      serum bone-specific alkaline phosphatase (-34.3% vs -20.1%, P < .01). AEs were 
      observed in 26.8% and 9.3% of the patients and treatment completion rates were 
      77.5% and 89.3% in the MIN and VD groups, respectively. Serious AEs were not 
      observed in either group. CONCLUSION: This study demonstrated the safety and 
      efficacy of monthly minodronate, suggesting that this treatment may be useful for 
      osteoporosis after gastrectomy (UMIN000015517).
CI  - (c) 2021 The Authors. Annals of Gastroenterological Surgery published by John Wiley 
      & Sons Australia, Ltd on behalf of The Japanese Society of Gastroenterology.
FAU - Hirota, Masashi
AU  - Hirota M
AUID- ORCID: 0000-0003-0581-8568
AD  - Department of Surgery Toyonaka municipal hospital Osaka Japan.
FAU - Takahashi, Tsuyoshi
AU  - Takahashi T
AD  - Department of Gastroenterological Surgery Osaka University Graduate School of 
      Medicine Osaka Japan.
FAU - Saito, Yurina
AU  - Saito Y
AD  - Department of Gastroenterological Surgery Osaka University Graduate School of 
      Medicine Osaka Japan.
FAU - Kawabata, Ryohei
AU  - Kawabata R
AD  - Department of Surgery Osaka Rosai Hospital Sakai Japan.
FAU - Nakatsuka, Rie
AU  - Nakatsuka R
AD  - Department of Surgery Osaka General medical center Osaka Japan.
FAU - Imamura, Hiroshi
AU  - Imamura H
AUID- ORCID: 0000-0002-4294-6289
AD  - Department of Surgery Toyonaka municipal hospital Osaka Japan.
FAU - Motoori, Masaaki
AU  - Motoori M
AD  - Department of Surgery Osaka General medical center Osaka Japan.
FAU - Makari, Yoichi
AU  - Makari Y
AD  - Department of Surgery Sakai city medical center Sakai Japan.
FAU - Takeno, Atsushi
AU  - Takeno A
AD  - Department of Surgery Kansai Rosai Hospital Amagasaki Japan.
FAU - Kishi, Kentaro
AU  - Kishi K
AD  - Department of Surgery Osaka police hospital Osaka Japan.
FAU - Adachi, Shinichi
AU  - Adachi S
AD  - Department of Surgery Ikeda municipal hospital Ikeda Japan.
FAU - Miyagaki, Hiromichi
AU  - Miyagaki H
AD  - Department of Surgery Saiseikai Senri Hospital Suita Japan.
FAU - Kurokawa, Yukinori
AU  - Kurokawa Y
AUID- ORCID: 0000-0002-2883-0132
AD  - Department of Gastroenterological Surgery Osaka University Graduate School of 
      Medicine Osaka Japan.
FAU - Yamasaki, Makoto
AU  - Yamasaki M
AD  - Department of Gastroenterological Surgery Osaka University Graduate School of 
      Medicine Osaka Japan.
FAU - Eguchi, Hidetoshi
AU  - Eguchi H
AUID- ORCID: 0000-0002-2318-1129
AD  - Department of Gastroenterological Surgery Osaka University Graduate School of 
      Medicine Osaka Japan.
FAU - Doki, Yuichiro
AU  - Doki Y
AD  - Department of Gastroenterological Surgery Osaka University Graduate School of 
      Medicine Osaka Japan.
LA  - eng
PT  - Journal Article
DEP - 20210709
PL  - Japan
TA  - Ann Gastroenterol Surg
JT  - Annals of gastroenterological surgery
JID - 101718062
PMC - PMC8560613
OTO - NOTNLM
OT  - active vitamin D
OT  - bone metabolism disorders
OT  - gastrectomy
OT  - intervention
OT  - minodronate
COIS- Conflicts of interest: Masashi Hirota, Tsuyoshi Takahashi, Yurina Saito, Ryohei 
      Kawabata, Rie Nakatsuka, Hiroshi Imamura, Masaaki Motoori, Yoichi Makari, Atsushi 
      Takeno, Kentaro Kishi, Shinichi Adachi, Hiromichi Miyagaki, Yukinori Kurokawa, 
      Makoto Yamasaki, Hidetoshi Eguchi, and Yuichiro Doki report no conflicts of 
      interest or financial ties with any of the firms mentioned in this report.
EDAT- 2021/11/11 06:00
MHDA- 2021/11/11 06:01
PMCR- 2021/07/09
CRDT- 2021/11/10 06:47
PHST- 2021/02/01 00:00 [received]
PHST- 2021/05/04 00:00 [revised]
PHST- 2021/05/10 00:00 [accepted]
PHST- 2021/11/10 06:47 [entrez]
PHST- 2021/11/11 06:00 [pubmed]
PHST- 2021/11/11 06:01 [medline]
PHST- 2021/07/09 00:00 [pmc-release]
AID - AGS312474 [pii]
AID - 10.1002/ags3.12474 [doi]
PST - epublish
SO  - Ann Gastroenterol Surg. 2021 Jul 9;5(6):754-766. doi: 10.1002/ags3.12474. 
      eCollection 2021 Nov.