Bone Microstructure After Gastrectomy Evaluating by Using HR-pQCT

Gastric Cancer Clinical Trial

Official title:

Chronological Change of Bone Microstructure After Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03398226
• Other study ID #: 17082126
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2017
• Last updated: January 12, 2018
• Start date: September 18, 2017
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2018
• Source: Nagasaki University
• Contact: Shinichiro Kobayashi, MD
• Phone: 958197316
• Email: shinichirokobayashi[@]nagasaki-u.ac.jp
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 79 Years

Eligibility

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).

Related Conditions & MeSH terms

• Gastric Cancer
• Osteoporosis
• Sarcopenia
• Stomach Neoplasms

Locations

Country	Name	City	State
Japan	Nagasaki University Hospital	Nagasaki

Sponsors (1)

Lead Sponsor	Collaborator
Nagasaki University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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