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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03251430
• Other study ID #: 17061943
• Status: Recruiting
• Phase: N/A
• First received: August 7, 2017
• Last updated: January 8, 2018
• Start date: September 20, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: January 2018
• Source: Nagasaki University
• Contact: Shinichiro Kobayashi, MD
• Phone: 81958197316
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: March 31, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Gastric Cancer
• Osteoporosis
• Sarcopenia
• Stomach Neoplasms

Intervention

Procedure:
• gastrectomy
Distal gastrectomy, Total gastrectomy

Locations

Country	Name	City	State
Japan	Nagasaki University Hospital	Nagasaki

Sponsors (1)

Lead Sponsor	Collaborator
Kobayashi Shinichiro

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	day1
Secondary	Comparing bone microstructure with sarcopenia	Correlation between bone mineral density in HR-pQCT and cross-sectional area of the abdominal psoas major muscle	day1
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)	day1
Secondary	Comparing bone microstructure with dual-energy X-ray absorptiometry	Correlation of bone mineral density between HR-pQCT and DXA	day1
Secondary	Comparing bone microstructure with quality of life (QOL-C30)	Patients will be asked to complete a short debriefing questionnaire covering questions (QOL-C30)	day1
Secondary	Comparing bone microstructure with quality of life (BDHQ)	Patients will be asked to complete a short debriefing questionnaire covering questions ( BDHQ)	day1
Secondary	Comparing bone microstructure with quality of life (FRAX)	Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX)	day1