Bone Microstructure After Gastrectomy Evaluating by Using HR-pQCT

Study Overview
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Brief Summary
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Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

Detailed Description
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The patients after gastrectomy loss appetite and decrease the weight. Total gastrectomy especially cause severe sarcopenia and metabolic change. Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The primary tools for assessing volumetric density and bone structure are quantitative computed tomography (QCT) and more recently, high-resolution peripheral quantitative computed tomography (HR-pQCT). However the validation of osteoporosis with HR-pQCT before and after gastrectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT before and after after endoscopic resection, distal gastrectomy, and total gastrectomy in the patients with gastric cancer.

Official Title
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Chronological Change of Bone Microstructure After Gastrectomy

Conditions
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Osteoporosis, Sarcopenia, Gastric Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planning ESD, DG, or TG due to gastric cancer Provide signed informed consent Exclusion Criteria: pregnancy Current use of the following osteoporosis agents; Teriparatide, Denosumab, and bisphosphonate Hyperthyroidism Hyperparathyroidism Present malignancy (except in situ carcinoma) Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy Other diseases which affect bone metabolism Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures Received > 3 months (or equivalent) of osteoporosis treatment Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br> | |
| Distal Gastrectomy (DG) group<br>38 patients planing distal gastrectomy due to gastric cancer | |
| Total Gastrectomy (TG) group<br>38 patients planing total gastrectomy due to gastric cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing bone microstructure in control, DG, and TG groups | volumetric bone mineral density loss comparing with before the treatments | 2 years after the treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing bone microstructure with sarcopenia | Correlation between bone mineral density in HR-pQCT and cross-sectional area of the abdominal psoas major muscle | Before the treatments and 1 and 2 years after the treatments | 
| Comparing bone microstructure with serum biomarkers of osteoporosis | Correlation between bone mineral density in HR-pQCT and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b) | Before the treatments and 1 and 2 years after the treatments | 
| Comparing bone microstructure with dual-energy X-ray absorptiometry | Correlation of bone mineral density between HR-pQCT and DXA | Before the treatments and 1 and 2 years after the treatments | 
| Comparing bone microstructure with quality of life (QOL-C30) | Patients will be asked to complete a short debriefing questionnaire covering questions.(QOL-C30). We compared the average sore about Valid and reliable 30-item questionnaire assessing health related quality of life (6 functional, 9 symptom) before and after treatments. The score about QOL-C30 is evaluated on a four level scale without Global quality of life. Global quality of life is evaluated on a seven level scale. | Before the treatments and 1 and 2 years after the treatments | 
| Comparing bone microstructure with quality of life (BDHQ) | Patients will be asked to complete a short debriefing questionnaire covering questions (BDHQ) B-DHQ is 58-item fixed-portion-type questionnaire The score about BDHQ is evaluated on a seven level scale. | Before the treatments and 1 and 2 years after the treatments | 
| Comparing bone microstructure with quality of life (FRAX) | Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX). FRAX score is 12. FRAX is 12-item fixed-portion-type questionnaire. The score about FRAX is evaluated on a two level scale. | Before the treatments and 1 and 2 years after the treatments |