Utility of monthly minodronate for osteoporosis after gastrectomy: Prospective multicenter randomized controlled trials

Hirota, Masashi; Takahashi, Tsuyoshi; Saito, Yuya; Kawabata, Ryohei; Nakatsuka, Rie; Imamura, Hiroshi; Motoori, Masaaki; Makari, Yoichi; Takeno, Atsushi; Kutsukake, Kentaro; Adachi, Shin‐ichi; Miyagaki, Hiromichi; Kurokawa, Yukinori; Yamasaki, Makoto; Eguchi, Hidetoshi; Doki, Yuichiro

doi:10.1002/ags3.12474

Cited by 3 publications

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References 48 publications

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“…23 Hirota et al, compared minodronate and eldecalcitol in post-operative patients with gastric cancer and the increase in mineral density of the lumbar spine was 4.52% in the minodronate group and 1.72% in the eldecalcitol group. 25 Similarly, Ha et al, compared outcomes of administration of a weekly dose of alendronate (70 mg) + daily elemental calcium (500 mg) with cholecalciferol (1,000 IU) with those of administration of daily elemental calcium (500 mg) with cholecalciferol (100 IU) only. They reported a significantly smaller decrease in mineral density of the lumbar spine in patients who received alendronate and those who did not (-0.28 AE 5.20 vs. 8.39 AE 7.41, respectively).…”

Section: Discussionmentioning

confidence: 99%

Protocol for a randomized study of the efficacy of ibandronic acid plus eldecalcitol in patients with gastric cancer after gastrectomy: A comparative study of different routes of administration of ibandronic acid

et al. 2023

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Background: Patients who undergo gastrectomy for gastric cancer are susceptible to osteoporosis. To prevent a decrease in bone mineral density, an appropriate prophylaxis is considered important to adjust the post-gastrectomy condition. In this study, we will compare two different routes of administration of ibandronic acid (oral or intravenous) plus eldecalcitol as a potentially more suitable treatment for patients at a high risk of fragile fracture. Protocol: This study protocol describes a randomized, active-controlled, non-blind, single-center, phase II trial. For patients in the investigational arm (Group A), sodium ibandronate hydrate will be administered intravenously once a month with daily oral intake of eldecalcitol; for those in the control arm (Group B), sodium ibandronate hydrate will be administered orally once a month with daily oral intake of eldecalcitol. We will recruit patients aged 45–85 years who have undergone gastrectomy for gastric cancer and are at a risk of fragility fractures. The study will include patients with existing vertebral fractures and/or femoral proximal fractures, or with lumbar and/or proximal femur bone mineral density of less than 80% of the young adult mean. The primary outcome of this study will be the change in lumbar bone mineral density. We will also evaluate the changes in femur bone mineral density, bone metabolism markers, health-related quality of life as evaluated using the EuroQol 5 Dimension (EQ-5D), and digestive symptoms as evaluated using the Gastrointestinal Symptom Rating Scale after 52 weeks of treatment. Conclusions: We believe that appropriate treatments that are adjusted to the condition of patients after gastrectomy are important for the prevention of bone mineral loss. Registration: This study was accepted by the Japan Registry of Clinical Trials (jRCT1041200059, November 6, 2021).

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Section: Discussionmentioning

confidence: 99%

Protocol for a randomized study of the efficacy of ibandronic acid plus eldecalcitol in patients with gastric cancer after gastrectomy: A comparative study of different routes of administration of ibandronic acid

et al. 2023

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show abstract

“…24 Similarly, Ha et al, compared outcomes of administration of a weekly dose of alendronate (70 mg) + daily elemental calcium (500 mg) with cholecalciferol (1,000 IU) with those of administration of daily elemental calcium (500 mg) with cholecalciferol (100 IU) only. They reported a significantly smaller decrease in mineral density of the lumbar spine in patients who received alendronate and those who did not (-0.28 AE 5.20 vs. 8.39 AE 7.41, respectively).…”

mentioning

confidence: 99%

Protocol for a randomized study of the efficacy of ibandronic acid plus eldecalcitol in patients with gastric cancer after gastrectomy: A comparative study of different routes of administration of ibandronic acid

et al. 2022

View full text Add to dashboard Cite

Background: Patients who undergo gastrectomy for gastric cancer are susceptible to osteoporosis. To prevent a decrease in bone mineral density, an appropriate prophylaxis is considered important to adjust the post-gastrectomy condition. In this study, we will compare two different routes of administration of ibandronic acid (oral or intravenous) plus eldecalcitol as a potentially more suitable treatment for patients at a high risk of fragile fracture. Protocol: This study protocol describes a randomized, active-controlled, non-blind, single-center, phase II trial. For patients in the investigational arm (Group A), sodium ibandronate hydrate will be administered intravenously once a month with daily oral intake of eldecalcitol; for those in the control arm (Group B), sodium ibandronate hydrate will be administered orally once a month with daily oral intake of eldecalcitol. We will recruit patients aged 20–85 years who have undergone gastrectomy for gastric cancer and are at a risk of fragility fractures. The study will include patients with existing vertebral fractures and/or femoral proximal fractures, or with lumbar and/or proximal femur bone mineral density of less than 80% of the young adult mean. The primary outcome of this study will be the change in lumbar bone mineral density. We will also evaluate the changes in femur bone mineral density, bone metabolism markers, health-related quality of life as evaluated using the EuroQol 5 Dimension (EQ-5D), and digestive symptoms as evaluated using the Gastrointestinal Symptom Rating Scale after 52 weeks of treatment. Conclusions: We believe that appropriate treatments that are adjusted to the condition of patients after gastrectomy are important for the prevention of bone mineral loss. Registration: This study was accepted by the Japan Registry of Clinical Trials (jRCT1041200059, November 6, 2021).

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Analysis of the risk factors for osteoporosis and its prevalence after gastrectomy for gastric cancer in older patients: a prospective study

et al. 2022

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Utility of monthly minodronate for osteoporosis after gastrectomy: Prospective multicenter randomized controlled trials

Abstract: This is an open access article under the terms of the Creat ive Commo ns Attri butio n-NonCo mmerc ial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Cited by 3 publications

References 48 publications

Protocol for a randomized study of the efficacy of ibandronic acid plus eldecalcitol in patients with gastric cancer after gastrectomy: A comparative study of different routes of administration of ibandronic acid

Protocol for a randomized study of the efficacy of ibandronic acid plus eldecalcitol in patients with gastric cancer after gastrectomy: A comparative study of different routes of administration of ibandronic acid

Protocol for a randomized study of the efficacy of ibandronic acid plus eldecalcitol in patients with gastric cancer after gastrectomy: A comparative study of different routes of administration of ibandronic acid

Analysis of the risk factors for osteoporosis and its prevalence after gastrectomy for gastric cancer in older patients: a prospective study

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