Bone Microstructure by Using HR-pQCT in Long Courses After Gastrectomy

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 in the long course after gastrectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

Official Title
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Assessment of Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography in Long Courses After Gastrectomy : a Prospective Observational Study

Conditions
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Osteoporosis, Sarcopenia, Gastric Cancer

Intervention / Treatment
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* Procedure: gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 5 years have elapsed since 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: 90 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>38 patients without gastrectomy , who are similar background in other group, are collected from date Pathologic analysis of primary osteoporosis: investigating age and osteoporosis related changes of bone microstructure by using HR-pQCT (UMIN000023535) | |
| Distal Gastrectomy (DG) group<br>38 patients with distal gastrectomy due to gastric cancer before no more than 5 years | Procedure: gastrectomy<br>* Distal gastrectomy, Total gastrectomy<br>|
| Total Gastrectomy (TG) group<br>38 patients with distal gastrectomy due to gastric cancer before no more than 5 years | Procedure: gastrectomy<br>* Distal gastrectomy, Total gastrectomy<br>|

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 | day1 | 

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 | day1 | 
| 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) | day1 | 
| Comparing bone microstructure with dual-energy X-ray absorptiometry | Correlation of bone mineral density between HR-pQCT and DXA | day1 | 
| Comparing bone microstructure with quality of life (QOL-C30) | Patients will be asked to complete a short debriefing questionnaire covering questions (QOL-C30) | day1 | 
| Comparing bone microstructure with quality of life (BDHQ) | Patients will be asked to complete a short debriefing questionnaire covering questions ( BDHQ) | day1 | 
| Comparing bone microstructure with quality of life (FRAX) | Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX) | day1 |