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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023535
Receipt No. 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 2016/08/09

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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 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ko Chiba
Organization Nagasaki University Hospital
Division name Department of orthopaedic surgery
Zip code
Address 1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan
TEL 095-819-7321
Email kohchiba@estate.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ko Chiba
Organization Nagasaki University Hospital
Division name Department of orthopaedic surgery
Zip code
Address 1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan
TEL 095-819-7321
Homepage URL
Email kohchiba@estate.ocn.ne.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
Address
Tel
Email

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
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 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 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
2016 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027107

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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