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

NCT ID: NCT03251430

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-20
• Study Completion Date: 2019-03-31

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.

Conditions

Osteoporosis; Sarcopenia; Gastric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

Distal Gastrectomy (DG) group

38 patients with distal gastrectomy due to gastric cancer before no more than 5 years

gastrectomy

Intervention Type: PROCEDURE

Distal gastrectomy, Total gastrectomy

Total Gastrectomy (TG) group

38 patients with distal gastrectomy due to gastric cancer before no more than 5 years

gastrectomy

Intervention Type: PROCEDURE

Distal gastrectomy, Total gastrectomy

Interventions

gastrectomy

Distal gastrectomy, Total gastrectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kobayashi Shinichiro

OTHER

Sponsor Role: lead

Responsible Party

Kobayashi Shinichiro

Principal Investigator in department of Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shinichiro Kobayashi, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,

Locations

Nagasaki University Hospital

Nagasaki, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Shinichiro Kobayashi, MD

Role: CONTACT

shinichirokobayashi@nagasaki-u.ac.jp

81958197316

Facility Contacts

Kobayashi Shinichiro, M.D.

Role: primary

shinichirokobayashi@nagasaki-u.ac.jp

+81958197316

Other Identifiers

17061943

Identifier Type: -

Identifier Source: org_study_id