Bone Microstructure After Gastrectomy Evaluating by Using HR-pQCT

Chronological Change of Bone Microstructure After Gastrectomy

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: Recruiting
• Conditions: Gastric Cancer; Sarcopenia; Osteoporosis

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 before and after gastrectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT before and after after endoscopic resection, distal gastrectomy, and total gastrectomy in the patients with gastric cancer.

• Study Type: Observational
• Enrollment (Anticipated): 42

Contacts and Locations

• Study Contact: Name: Shinichiro Kobayashi, MD; Phone Number: 958197316; Email: shinichirokobayashi@nagasaki-u.ac.jp

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Japanese

Description

Inclusion Criteria:

• Planning ESD, 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Control group
Distal Gastrectomy (DG) group; 38 patients planing distal gastrectomy due to gastric cancer
Total Gastrectomy (TG) group; 38 patients planing total gastrectomy due to gastric cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing bone microstructure in control, DG, and TG groups	volumetric bone mineral density loss comparing with before the treatments	2 years after the treatments

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	Before the treatments and 1 and 2 years after the treatments
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)	Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with dual-energy X-ray absorptiometry	Correlation of bone mineral density between HR-pQCT and DXA	Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with quality of life (QOL-C30)	Patients will be asked to complete a short debriefing questionnaire covering questions.(QOL-C30). We compared the average sore about Valid and reliable 30-item questionnaire assessing health related quality of life (6 functional, 9 symptom) before and after treatments. The score about QOL-C30 is evaluated on a four level scale without Global quality of life. Global quality of life is evaluated on a seven level scale.	Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with quality of life (BDHQ)	Patients will be asked to complete a short debriefing questionnaire covering questions (BDHQ) B-DHQ is 58-item fixed-portion-type questionnaire The score about BDHQ is evaluated on a seven level scale.	Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with quality of life (FRAX)	Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX). FRAX score is 12. FRAX is 12-item fixed-portion-type questionnaire. The score about FRAX is evaluated on a two level scale.	Before the treatments and 1 and 2 years after the treatments

Collaborators and Investigators

• Sponsor: Nagasaki University

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Anticipated): March 31, 2020
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: September 17, 2017
• First Submitted That Met QC Criteria: January 7, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Bone Diseases; Muscular Atrophy; Atrophy; Bone Diseases, Metabolic; Sarcopenia; Osteoporosis
• Other Study ID Numbers: 17082126

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