UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045408 |
|---|---|
| Receipt number | R000051848 |
| Scientific Title | The effect of geometric bone quality on bone strength in patients with secondary osteoporosis: Cross-sectional observational research |
| Date of disclosure of the study information | 2021/09/07 |
| Last modified on | 2021/09/07 18:20:07 |
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Basic information
Public title
The effect of geometric bone quality on bone strength in patients with
secondary osteoporosis: Cross-sectional observational research
Acronym
The effect of geometric bone quality on bone strength in patients with
secondary osteoporosis: Cross-sectional observational research
Scientific Title
The effect of geometric bone quality on bone strength in patients with
secondary osteoporosis: Cross-sectional observational research
Scientific Title:Acronym
The effect of geometric bone quality on bone strength in patients with
secondary osteoporosis: Cross-sectional observational research
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the role of bone microarchitecture on bone fragility in patients with secondary osteoporosis.
Basic objectives2
Others
Basic objectives -Others
This study aims to identify factors causing bone fragility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vertebral fracture
bone microarchitecture
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have attended the Department of Endocrinology and Metabolism, Shimane University Hospital between April 1, 1998, and March 31, 2021.
Key exclusion criteria
Nothing particular
Target sample size
1150
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Shimane University Faculty of Medicine
Division name
Internal medicine 1
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2183
masa-ya@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Shimane University Faculty of Medicine
Division name
Internal medicine 1
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2183
Homepage URL
masa-ya@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University Hospital, Clinical Trial Review Board
Address
89-1 Enya-cho, Izumo, Shimane
Tel
0853-20-2515
kenkyu@med.shimane-u.ac.jp
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
| 2021 | Year | 09 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will investigate the effect of bone microarchitecture on bone fragility in patients with secondary osteoporosis.
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2021 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051848
