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Trial Title:
Bone Microstructure by Using HR-pQCT After Esophagectomy
NCT ID:
NCT05812235
Condition:
Osteoporosis
Sarcopenia
Esophageal Cancer
Conditions: Official terms:
Osteoporosis
Sarcopenia
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
esophagectomy
Description:
esophagectomy
Arm group label:
Esophagectomy
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.
Criteria for eligibility:
Study pop:
Japanese
Sampling method:
Probability Sample
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).
Gender:
Male
Minimum age:
50 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
May 25, 2023
Completion date:
March 31, 2027
Lead sponsor:
Agency:
Nagasaki University
Agency class:
Other
Source:
Nagasaki University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05812235
