Clinical trial NCT05812235: Bone Microstructure by Using HR-pQCT After Esophagectomy
Official title: Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography After Esophagectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoporosis
Sarcopenia
Esophageal Cancer
Lead sponsor: Nagasaki University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 118
Sex: MALE
Minimum age (years): 50
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: Esophagectomy is most curative treatment to esophageal cancer. However, osteoporosis , 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 surgery. 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 esophagectomy. At least 3 years should have elapsed since operation without recurrence of esophageal cancer.

Detailed description: The patients after esophagectomy loss appetite and decrease the weight. Esophagectomy especially cause severe sarcopenia and metabolic change. Osteoporosis, 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 esophagectomy. 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 esophagectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT in the long course after esophagectomy. At least 3 years should have elapsed since esophagectomy without any recurrence.

Eligibility criteria: Inclusion Criteria:

* At least 3 years have elapsed since esophagectomy due to esophageal cancer
* Provide signed informed consent

Exclusion Criteria:

* Current use of the following osteoporosis agents; Teriparatide, Denosumab, and - -
* bisphosphonate
* Present malignancy (except in situ carcinoma)
* Radiotherapy
* 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 and Esophagectomy groups
timeFrame: 1day
Secondary outcomes:
measure: Comparing bone microstructure with serum biomarkers of osteoporosis
timeFrame: 1day
measure: Comparing bone microstructure with dual-energy X-ray absorptiometry
timeFrame: 1day
Other outcomes:
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