OsteoporosisNCT05812235
Bone Microstructure by Using HR-pQCT After Esophagectomy
An observational study of Osteoporosis and Sarcopenia, run by Nagasaki University.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Sarcopenia, Esophageal Cancer
- What is being tested?
- esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2023to 31 Mar 2027
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Japanese
Who may be able to join
- At least 3 years have elapsed since esophagectomy due to esophageal cancer
- Provide signed informed consent
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography After Esophagectomy
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.
Read the 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.
- Conditions
- Osteoporosis, Sarcopenia, Esophageal Cancer
- Being tested
- esophagectomy
- Medical subject headings
- Osteoporosis, Sarcopenia, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagectomyProcedure or surgery
esophagectomy
| Study group | Role | What they receive |
|---|---|---|
| Esophagectomy | 48 patients with esophagectomy due to esophageal cancer before no more than 3 years Receives: Procedure: esophagectomy | |
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing bone microstructure in control and Esophagectomy groups
volumetric bone mineral density
Measured: 1day
Secondary outcomes (2)
Comparing bone microstructure with serum biomarkers of osteoporosis
Correlation between bone mineral density in esophagectomy and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)
Measured: 1day
Comparing bone microstructure with dual-energy X-ray absorptiometry
Correlation of bone mineral density between esophagectomy and DXA
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start25 May 2023 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Nagasaki University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kobayashi Shinichiro, Nagasaki University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812235
- Sponsor's protocol ID
- NagasakiU3
- Status last verified
- Apr 2023
- First submitted
- 2 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography After Esophagectomy
- ClinicalTrials.gov ID
- NCT05812235
- Acronym / sponsor ID
- NagasakiU3
- Conditions
- Osteoporosis, Sarcopenia, Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Nagasaki UniversityUniversity, hospital or other
- Study start
- 25 May 2023 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esophagectomy | – | Procedure: esophagectomy48 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) |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Japanese
Key inclusion criteria (2 listed)
- At least 3 years have elapsed since esophagectomy due to esophageal cancer
- Provide signed informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esophagectomyesophagectomy | Procedure or surgery | Esophagectomy |
Primary outcome
Comparing bone microstructure in control and Esophagectomy groups
Time frame: 1day
volumetric bone mineral density
2 secondary outcomes
Comparing bone microstructure with serum biomarkers of osteoporosis
Time frame: 1day
Comparing bone microstructure with dual-energy X-ray absorptiometry
Time frame: 1day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Sarcopenia, run by Nagasaki University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shinichiro Kobayashi (0958197316, shinichirokobayashi@nagasaki-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing bone microstructure in control and Esophagectomy groups (time frame: 1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.