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

• Conditions: Gastric Cancer; Osteoporosis; Sarcopenia
• Interventions: Procedure: gastrectomy

• Registration Number: NCT03251430
• Lead Sponsor: Kobayashi Shinichiro

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-13
• Study First Posted: 2017-08-16
• Study Start: 2017-09-20
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-09
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Distal Gastrectomy (DG) group	gastrectomy	38 patients with distal gastrectomy due to gastric cancer before no more than 5 years
Total Gastrectomy (TG) group	gastrectomy	38 patients with distal gastrectomy due to gastric cancer before no more than 5 years

Primary Outcome Measures

Name	Time	Method
Comparing bone microstructure in control, DG, and TG groups	day1	volumetric bone mineral density

Secondary Outcome Measures

Name	Time	Method
Comparing bone microstructure with serum biomarkers of osteoporosis	day1	Correlation between bone mineral density in HR-pQCT and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)
Comparing bone microstructure with sarcopenia	day1	Correlation between bone mineral density in HR-pQCT and cross-sectional area of the abdominal psoas major muscle
Comparing bone microstructure with quality of life (FRAX)	day1	Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX)
Comparing bone microstructure with quality of life (QOL-C30)	day1	Patients will be asked to complete a short debriefing questionnaire covering questions (QOL-C30)
Comparing bone microstructure with dual-energy X-ray absorptiometry	day1	Correlation of bone mineral density between HR-pQCT and DXA
Comparing bone microstructure with quality of life (BDHQ)	day1	Patients will be asked to complete a short debriefing questionnaire covering questions ( BDHQ)

Trial Locations

Locations (1)

Nagasaki University Hospital; 🇯🇵 Nagasaki, Japan