UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027927 |
|---|---|
| Receipt number | R000031990 |
| Scientific Title | Bone structural changes long-term after gastrectomy evaluated by HR-pQCT |
| Date of disclosure of the study information | 2018/06/30 |
| Last modified on | 2018/02/24 21:33:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Bone structural changes long-term after gastrectomy evaluated by HR-pQCT
Acronym
Bone structural changes long-term after gastrectomy evaluated by HR-pQCT
Scientific Title
Bone structural changes long-term after gastrectomy evaluated by HR-pQCT
Scientific Title:Acronym
Bone structural changes long-term after gastrectomy evaluated by HR-pQCT
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate changes in the bone architectures as assessed using
HR-pQCT, more than 5 years after gastrectomy and correlate them to changes in selected biochemical markers.
Basic objectives2
Others
Basic objectives -Others
The bone architectures more than 5 years after gastrectomy are compared with case matched selected peoples without gastrectomy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of bone architectures as assessed using HR-pQCT
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Survivers 5 years after subtotal and total gastrectomy to gastric cancer
2. Age: 60 - 90 years old
3. Gender: male and female
4. Obtaining informed consent
Key exclusion criteria
1. pregnancy
2. continuing treatment to advanced malignant tumor
3. treatment to osteoporosis with teriparatide, denosumab, and bisphosphonate
4. The patients who are not appropriate for this research
Target sample size
114
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Eguchi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgery
Zip code
Address
sakamoto 1-7-1, Nagasaki city
TEL
095-819-7316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Kobayashi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgery
Zip code
Address
sakamoto 1-7-1, Nagasaki city
TEL
095-819-7316
Homepage URL
shinichirokobayashi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
a Grant-in-Aid for Scientific Research from Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2017 | Year | 06 | Month | 25 | Day |
Last modified on
| 2018 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031990
