UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023535 |
|---|---|
| Receipt number | R000027107 |
| Scientific Title | Pathologic analysis of primary osteoporosis: investigating age and osteoporosis related changes of bone microstructure by using HR-pQCT |
| Date of disclosure of the study information | 2016/08/09 |
| Last modified on | 2025/01/28 13:01:51 |
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Basic information
Public title
Pathologic analysis of primary osteoporosis: investigating age and osteoporosis related changes of bone microstructure by using HR-pQCT
Acronym
Pathologic analysis of primary osteoporosis by using HR-pQCT
Scientific Title
Pathologic analysis of primary osteoporosis: investigating age and osteoporosis related changes of bone microstructure by using HR-pQCT
Scientific Title:Acronym
Pathologic analysis of primary osteoporosis by using HR-pQCT
Region
| Japan |
Condition
Condition
Primary osteoporosis
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyzing the microstructure of the cortical and trabecular bone in younger and older adults cross-sectionally and longitudinally by using HR-pQCT, and investigating the age-related and the osteoporosis-related changes
Basic objectives2
Others
Basic objectives -Others
Analyzing bone microstructure by using HR-pQCT
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Age-related and the osteoporosis-related changes of cortical and trabecular bone microstructure
Key secondary outcomes
The difference of age-related and osteoporosis-related charges of cortical and trabecular bone microstructure between men and women, or weight bearing and non weight bearing site
The relationship between bone microstructure, and bone mineral density or bone metabolic marker
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age: over 20 when we get consent
2) Sex: no object
3) In or out patient: no object
4) Patients after receiving a sufficient explanation Upon participation in this study, on the thorough understanding, that document consent is obtained by the free will of the study in person
Key exclusion criteria
1) Patients with rheumatoid arthritis, with paralysis due to a stroke, with malignancy, undergoing hemodialysis, or taking osteoporosis drugs or glucocorticoid
2) Those who can not keep their limbs stable
3) Patients who are pregnant and have a possibility of being pregnant
4) Others who the principal investigator has determined are inappropriate as a subject
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Ko |
| Middle name | |
| Last name | Chiba |
Organization
Nagasaki University Hospital
Division name
Department of orthopaedic surgery
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan
TEL
095-819-7321
kohchiba@estate.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Chiba |
Organization
Nagasaki University Hospital
Division name
Department of orthopaedic surgery
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan
TEL
095-819-7321
Homepage URL
kohchiba@estate.ocn.ne.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of orthopaedic surgery, Nagaski University Hospital
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
長崎大学病院（長崎県）/ Nagasaki University Hospital (Nagasaki prefecture)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design;
Observational study
Object recruitment;
All patients who admitted in Nagasaki university hospital and meet the selection criteria from December 2015 to November 2018
Management information
Registered date
| 2016 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027107
