Bone Microstructure by Using HR-pQCT After Esophagectomy
1 other identifier
observational
118
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2023
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2023
CompletedFirst Posted
Study publicly available on registry
April 13, 2023
CompletedStudy Start
First participant enrolled
May 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedApril 24, 2023
April 1, 2023
2.8 years
April 2, 2023
April 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Comparing bone microstructure in control and Esophagectomy groups
volumetric bone mineral density
1day
Secondary Outcomes (2)
Comparing bone microstructure with serum biomarkers of osteoporosis
1day
Comparing bone microstructure with dual-energy X-ray absorptiometry
1day
Study Arms (2)
Esophagectomy
48 patients with esophagectomy due to esophageal cancer before no more than 3 years
Healthy Control
70 patients without gastrectomy , who are similar background in other group, are collected from date Pathologic analysis of primary osteoporosis: investigating age and osteoporosis related changes of bone microstructure by using HR-pQCT (UMIN000023535)
Interventions
Eligibility Criteria
Japanese
You may qualify if:
- At least 3 years have elapsed since esophagectomy due to esophageal cancer
- Provide signed informed consent
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Protein
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Surgery
Study Record Dates
First Submitted
April 2, 2023
First Posted
April 13, 2023
Study Start
May 25, 2023
Primary Completion
March 1, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
April 24, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share