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 [version 2; peer review: 2 approved]

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)

Premature death associated with long-term evacuation among a vulnerable population after the Fukushima nuclear disaster

Rationale: The health vulnerability of certain populations such as children, the elderly and individuals with illnesses or physical disability can become significant in disasters. After the 2011 Fukushima Daiichi Nuclear Power Plant (FDNPP) accident, significant health impacts on vulnerable populations were observed during early or mid-term phase of the disaster, presumably associated with the evacuation. However, there is limited information available on the health impacts owing to long-term evacuation after disaster among them. Patient concerns: A 56-year-old physically challenged male with arteriovenous malformation on his right lower limb, diagnosed when he was 2 years’ old, lived near the FDNPP. He and his family were forced to evacuate immediately after the accident. Diagnosis: Three months after evacuation following the FDNPP accident, he developed a refractory foot ulcer associated with atrial fibrillation and congestive cardiac failure because of deterioration of arteriovenous malformation, presumably led by repeated evacuations. Intervention: Although anticoagulation therapy and diuretic therapy improved his cardiac failure in the initial admission, he decided to only be treated with supportive care after revelation that his arteriovenous malformation was no longer eligible for aggressive intervention. Outcome: Three years after the long-term evacuation in temporary houses, the patient died of bleeding and infection of the ulcer. Lessons: This case suggests that long-term evacuation for individuals with physical disability may lead to significant health impacts, and even premature death, through the deterioration of daily life activities due to physical and psychological burdens. This case presents a need for further research on ways that disasters impact the health of individuals with physical disabilities, and greater disaster preparation for the needs of populations with physical disabilities