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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019960
Receipt No. R000021320
Scientific Title Reserch about precision of HR-pQCT
Date of disclosure of the study information 2015/11/27
Last modified on 2016/12/08

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Basic information
Public title Reserch about precision of HR-pQCT
Acronym Reserch about precision of HR-pQCT
Scientific Title Reserch about precision of HR-pQCT
Scientific Title:Acronym Reserch about precision of HR-pQCT
Region
Japan

Condition
Condition not designated
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the precision of measurement of high-resolution peripheral quantitative CT (HR-pQCT)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraobserver reproducibility of trabecular and cortical microstructure, and finite-element analysis
Key secondary outcomes Interobserver reproducibility of trabecular and cortical microstructure, and finite-element analysis

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
80 years-old >=
Gender Male and Female
Key inclusion criteria Age:over 20 when we get consent
Sex:no object

In or out patient: no object

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 Those with missing limbs

Those who can not be limbs of rest and retention

Patients that may have been pregnant and pregnant

Others, who principal investigator has determined to be inappropriate as a subject
Target sample size 15

Research contact person
Last 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
1st 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 Nagaski University Hospital
Institute
Department

Funding Source
Organization Nagaski University Hospital Department of orthopaedic surgery
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 YES
Study ID_1 27-5-16
Org. issuing International ID_1 Clinical reserch, Nagasaki University Hospital
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
2015 Year 11 Month 27 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2015 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design: A cohort study
Patients recruitment: All that meet the selection criteria in patients admitted to our facility or volunteers from August 2015 to September 2015.
Data collection: Trabecular and cortical bone microstructure parameters and micro-finite-element analysis

Management information
Registered date
2015 Year 11 Month 27 Day
Last modified on
2016 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021320

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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