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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03251430
Enrollment
114
Registered
2017-08-16
Start date
2017-09-20
Completion date
2019-03-31
Last updated
2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Osteoporosis, Sarcopenia

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.

Interventions

PROCEDUREgastrectomy

Distal gastrectomy, Total gastrectomy

Sponsors

Kobayashi Shinichiro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Comparing bone microstructure in control, DG, and TG groupsday1volumetric bone mineral density

Secondary

MeasureTime frameDescription
Comparing bone microstructure with serum biomarkers of osteoporosisday1Correlation between bone mineral density in HR-pQCT and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)
Comparing bone microstructure with dual-energy X-ray absorptiometryday1Correlation of bone mineral density between HR-pQCT and DXA
Comparing bone microstructure with sarcopeniaday1Correlation between bone mineral density in HR-pQCT and cross-sectional area of the abdominal psoas major muscle
Comparing bone microstructure with quality of life (BDHQ)day1Patients will be asked to complete a short debriefing questionnaire covering questions ( BDHQ)
Comparing bone microstructure with quality of life (FRAX)day1Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX)
Comparing bone microstructure with quality of life (QOL-C30)day1Patients will be asked to complete a short debriefing questionnaire covering questions (QOL-C30)

Countries

Japan

Contacts

Primary ContactShinichiro Kobayashi, MD
shinichirokobayashi@nagasaki-u.ac.jp81958197316

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026