OsteoporosisNCT03251430
Bone Microstructure by Using HR-pQCT in Long Courses After Gastrectomy
An observational study of Osteoporosis and Sarcopenia, run by Kobayashi Shinichiro 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 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Sarcopenia, Gastric Cancer
- What is being tested?
- gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 114 participants
- Where
- 1 siteJapan
- Study dates
- 20 Sep 2017to 31 Mar 2019
- How long will I take part?
- 1 Day
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Japanese
Who may be able to join
- At least 5 years have elapsed since 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: Assessment of Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography in Long Courses After Gastrectomy : a Prospective Observational Study
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 in the long course after gastrectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.
- Conditions
- Osteoporosis, Sarcopenia, Gastric Cancer
- Being tested
- gastrectomy
- 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.
gastrectomyProcedure or surgery
Distal gastrectomy, Total gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Control group | 38 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) | |
| Distal Gastrectomy (DG) group | 38 patients with distal gastrectomy due to gastric cancer before no more than 5 years Receives: Procedure: gastrectomy | |
| Total Gastrectomy (TG) group | 38 patients with distal gastrectomy due to gastric cancer before no more than 5 years Receives: Procedure: gastrectomy |
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
Measured: day1
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: day1
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: day1
Comparing bone microstructure with dual-energy X-ray absorptiometry
Correlation of bone mineral density between HR-pQCT and DXA
Measured: day1
Comparing bone microstructure with quality of life (QOL-C30)
Patients will be asked to complete a short debriefing questionnaire covering questions (QOL-C30)
Measured: day1
Comparing bone microstructure with quality of life (BDHQ)
Patients will be asked to complete a short debriefing questionnaire covering questions ( BDHQ)
Measured: day1
Comparing bone microstructure with quality of life (FRAX)
Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX)
Measured: day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start20 Sep 2017
- Primary completion1 Mar 2019 (estimated)
- Study completion31 Mar 2019 (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
- 114 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kobayashi Shinichiro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kobayashi Shinichiro, Nagasaki University
- Investigators
- Shinichiro Kobayashi, MD, Principal investigator, Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251430
- Sponsor's protocol ID
- 17061943
- Status last verified
- Jan 2018
- First submitted
- 7 Aug 2017
- Last updated
- 9 Jan 2018
- 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 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography in Long Courses After Gastrectomy : a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03251430
- Acronym / sponsor ID
- 17061943
- Conditions
- Osteoporosis, Sarcopenia, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Kobayashi ShinichiroUniversity, hospital or other
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 16 Aug 2017 (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 in the long course after gastrectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –38 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) |
| Distal Gastrectomy (DG) group | – | Procedure: gastrectomy38 patients with distal gastrectomy due to gastric cancer before no more than 5 years |
| Total Gastrectomy (TG) group | – | Procedure: gastrectomy38 patients with distal gastrectomy due to gastric cancer before no more than 5 years |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Japanese
Key inclusion criteria (2 listed)
- At least 5 years have elapsed since 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastrectomyDistal gastrectomy, Total gastrectomy | Procedure or surgery | Distal Gastrectomy (DG) group, Total Gastrectomy (TG) group |
Primary outcome
Comparing bone microstructure in control, DG, and TG groups
Time frame: day1
volumetric bone mineral density
6 secondary outcomes
Comparing bone microstructure with sarcopenia
Time frame: day1
Comparing bone microstructure with serum biomarkers of osteoporosis
Time frame: day1
Comparing bone microstructure with dual-energy X-ray absorptiometry
Time frame: day1
Comparing bone microstructure with quality of life (QOL-C30)
Time frame: day1
Comparing bone microstructure with quality of life (BDHQ)
Time frame: day1
Comparing bone microstructure with quality of life (FRAX)
Time frame: day1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis
Recruiting
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
Osteoporosis, Arthroplasty Complications
Not yet recruiting
Exercise and Fall Prevention
Osteopenia, Osteoporosis
Enrolling by invitationPhase 3
Quanduzhong Capsules for Primary Osteoporosis
Primary Osteoporosis
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia
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.
Shinichiro Kobayashi, MD principal investigator
Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,
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 Kobayashi Shinichiro 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 9 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 (81958197316, 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: day1). 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 9 Jan 2018.