Clinical trial NCT03251430: Bone Microstructure by Using HR-pQCT in Long Courses After Gastrectomy
Official title: Assessment of Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography in Long Courses After Gastrectomy : a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Sarcopenia
Gastric Cancer
Lead sponsor: Nagasaki University
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 114
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese

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.

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).

Primary outcomes:
measure: Comparing bone microstructure in control, DG, and TG groups
timeFrame: day1
Secondary outcomes:
measure: Comparing bone microstructure with sarcopenia
timeFrame: day1
measure: Comparing bone microstructure with serum biomarkers of osteoporosis
timeFrame: day1
measure: Comparing bone microstructure with dual-energy X-ray absorptiometry
timeFrame: day1
measure: Comparing bone microstructure with quality of life (QOL-C30)
timeFrame: day1
measure: Comparing bone microstructure with quality of life (BDHQ)
timeFrame: day1
measure: Comparing bone microstructure with quality of life (FRAX)
timeFrame: day1
Other outcomes:
Locations:
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
Study officials:
affiliation: Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,
name: Shinichiro Kobayashi, MD
role: PRINCIPAL_INVESTIGATOR
References: