OsteoporosisNCT03398226
Bone Microstructure After Gastrectomy Evaluating by Using HR-pQCT
An observational study of Osteoporosis and Sarcopenia, run by Nagasaki University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Sarcopenia, Gastric Cancer
- How many people
- 42 participants
- Where
- 1 siteJapan
- Study dates
- 18 Sep 2017to 31 Mar 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Japanese
Who may be able to join
- Planning ESD, DG, or TG due to gastric cancer
- Provide signed informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Nagasaki University Hospital
Nagasaki, 852-8501
Kobayashi Shinichiro, M.D., +81958197316, shinichirokobayashi@nagasaki-u.ac.jp
About this study
Official title: Chronological Change of Bone Microstructure After Gastrectomy
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.
Read the 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.
- Conditions
- Osteoporosis, Sarcopenia, Gastric Cancer
- Medical subject headings
- Osteoporosis, Sarcopenia, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Not described | |
| Distal Gastrectomy (DG) group | 38 patients planing distal gastrectomy due to gastric cancer | |
| Total Gastrectomy (TG) group | 38 patients planing total gastrectomy due to gastric cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing bone microstructure in control, DG, and TG groups
volumetric bone mineral density loss comparing with before the treatments
Measured: 2 years after the treatments
Secondary outcomes (6)
Comparing bone microstructure with sarcopenia
Correlation between bone mineral density in HR-pQCT and cross-sectional area of the abdominal psoas major muscle
Measured: Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with serum biomarkers of osteoporosis
Correlation between bone mineral density in HR-pQCT and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)
Measured: Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with dual-energy X-ray absorptiometry
Correlation of bone mineral density between HR-pQCT and DXA
Measured: Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with quality of life (QOL-C30)
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.
Measured: Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with quality of life (BDHQ)
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.
Measured: Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with quality of life (FRAX)
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.
Measured: Before the treatments and 1 and 2 years after the treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start18 Sep 2017
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2023 (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
- 42 participants (estimated)
- Target duration
- 2 Years
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
- NCT03398226
- Sponsor's protocol ID
- 17082126
- Status last verified
- Jan 2018
- First submitted
- 17 Sep 2017
- Last updated
- 17 Jan 2018
- Results posted
- 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 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronological Change of Bone Microstructure After Gastrectomy
- ClinicalTrials.gov ID
- NCT03398226
- Acronym / sponsor ID
- 17082126
- Conditions
- Osteoporosis, Sarcopenia, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Nagasaki UniversityUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 12 Jan 2018 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | – |
| Distal Gastrectomy (DG) group | – | –38 patients planing distal gastrectomy due to gastric cancer |
| Total Gastrectomy (TG) group | – | –38 patients planing total gastrectomy due to gastric cancer |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Japanese
Key inclusion criteria (2 listed)
- Planning ESD, DG, or TG due to gastric cancer
- Provide signed informed consent
Key exclusion criteria (10 listed)
- pregnancy
- Current use of the following osteoporosis agents; Teriparatide, Denosumab, and bisphosphonate
- Hyperthyroidism
- Hyperparathyroidism
- Present malignancy (except in situ carcinoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparing bone microstructure in control, DG, and TG groups
Time frame: 2 years after the treatments
volumetric bone mineral density loss comparing with before the treatments
6 secondary outcomes
Comparing bone microstructure with sarcopenia
Time frame: Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with serum biomarkers of osteoporosis
Time frame: Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with dual-energy X-ray absorptiometry
Time frame: Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with quality of life (QOL-C30)
Time frame: Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with quality of life (BDHQ)
Time frame: Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with quality of life (FRAX)
Time frame: Before the treatments and 1 and 2 years after the treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Sarcopenia, run by Nagasaki University at 1 site in Japan.
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 10 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: status not confirmed, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shinichiro Kobayashi, MD (958197316, 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, DG, and TG groups (time frame: 2 years after the treatments). 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 17 Jan 2018; AzTrials last refreshed its copy on 27 Oct 2026.