Assessment of Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography in Long Courses After Gastrectomy : a Prospective Observational Study
| Registry | NCT03251430 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 114 (Estimated) |
| Sponsor | Kobayashi Shinichiro (Other) |
| Conditions | Osteoporosis, Sarcopenia, Gastric Cancer |
| Interventions | gastrectomy (Procedure) |
| Dates | start 2017-09-20, primary completion 2019-03-01 (estimated), completion 2019-03-31 (estimated), first posted 2017-08-16, last updated 2018-01-09 |
| Locations | 1 site in Japan |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control group | 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 | Procedure: gastrectomy | 38 patients with distal gastrectomy due to gastric cancer before no more than 5 years | |
| Total Gastrectomy (TG) group | Procedure: gastrectomy | 38 patients with distal gastrectomy due to gastric cancer before no more than 5 years |
Sex: All, ages: 60 Years to 90 Years, accepts healthy volunteers
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).
| Facility | City | Country | Status |
|---|---|---|---|
| Nagasaki University Hospital | Nagasaki | Japan | Recruiting |