Bone Microstructure After Gastrectomy Evaluating by Using HR-pQCT
- Conditions
- Gastric CancerOsteoporosisSarcopenia
- Registration Number
- NCT03398226
- Lead Sponsor
- Nagasaki University
- 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 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
- Planning ESD, DG, or TG due to gastric cancer
- Provide signed informed consent
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparing bone microstructure in control, DG, and TG groups 2 years after the treatments volumetric bone mineral density loss comparing with before the treatments
- Secondary Outcome Measures
Name Time Method Comparing bone microstructure with quality of life (QOL-C30) Before the treatments and 1 and 2 years after the treatments 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.
Comparing bone microstructure with quality of life (BDHQ) Before the treatments and 1 and 2 years after the treatments 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.
Comparing bone microstructure with quality of life (FRAX) Before the treatments and 1 and 2 years after the treatments 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.
Comparing bone microstructure with sarcopenia Before the treatments and 1 and 2 years after the treatments Correlation between bone mineral density in HR-pQCT and cross-sectional area of the abdominal psoas major muscle
Comparing bone microstructure with serum biomarkers of osteoporosis Before the treatments and 1 and 2 years after the treatments Correlation between bone mineral density in HR-pQCT and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)
Comparing bone microstructure with dual-energy X-ray absorptiometry Before the treatments and 1 and 2 years after the treatments Correlation of bone mineral density between HR-pQCT and DXA
Trial Locations
- Locations (1)
Nagasaki University Hospital
🇯🇵Nagasaki, Japan