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

January 8, 2018 updated by: Kobayashi Shinichiro

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Nagasaki, Japan, 852-8501
        • Recruiting
        • Nagasaki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Japanese

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
38 patients with distal gastrectomy due to gastric cancer before no more than 5 years
Procedure: gastrectomy
Distal gastrectomy, Total gastrectomy
Total Gastrectomy (TG) group
38 patients with distal gastrectomy due to gastric cancer before no more than 5 years
Procedure: gastrectomy
Distal gastrectomy, Total gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing bone microstructure in control, DG, and TG groups
Time Frame: day1
volumetric bone mineral density
day1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing bone microstructure with sarcopenia
Time Frame: day1
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
Time Frame: day1
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
Time Frame: day1
Correlation of bone mineral density between HR-pQCT and DXA
day1
Comparing bone microstructure with quality of life (QOL-C30)
Time Frame: day1
Patients will be asked to complete a short debriefing questionnaire covering questions (QOL-C30)
day1
Comparing bone microstructure with quality of life (BDHQ)
Time Frame: day1
Patients will be asked to complete a short debriefing questionnaire covering questions ( BDHQ)
day1
Comparing bone microstructure with quality of life (FRAX)
Time Frame: day1
Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX)
day1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kobayashi Shinichiro

Investigators

  • Principal Investigator: Shinichiro Kobayashi, MD, Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 20, 2017

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

March 31, 2019

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

August 13, 2017

First Posted (ACTUAL)

August 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17061943

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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