UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038154 |
|---|---|
| Receipt number | R000043496 |
| Scientific Title | Related factors between romosozumab, a sclerostin monoclonal antibody, and bone mineral density as well as bone turnover markers: A prospective observational study |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2019/09/30 16:01:17 |
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Basic information
Public title
Related factors between romosozumab, a sclerostin monoclonal antibody, and bone mineral density as well as bone turnover markers: A prospective observational study
Acronym
Related factors between romosozumab, a sclerostin monoclonal antibody, and bone mineral density as well as bone turnover markers: A prospective observational study
Scientific Title
Related factors between romosozumab, a sclerostin monoclonal antibody, and bone mineral density as well as bone turnover markers: A prospective observational study
Scientific Title:Acronym
Related factors between romosozumab, a sclerostin monoclonal antibody, and bone mineral density as well as bone turnover markers: A prospective observational study
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to examine related factors between romosozumab, a sclerostin monoclonal antibody, and bone mineral density as well as bone turnover markers.
Basic objectives2
Others
Basic objectives -Others
We aim to examine related factors between romosozumab, a sclerostin monoclonal antibody, and bone mineral density as well as bone turnover markers.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Background (interview)
general blood, urine markers
bone-metabolism related markers
BMD
X ray
Key secondary outcomes
screlostin (pg/mL)
abodominal CT
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with osteoporosis who come to Internal Medicine 1 in Shimane University and agree with participation in this stusy
Key exclusion criteria
nothing
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichiro |
| Middle name | |
| Last name | Tanaka |
Organization
Shimane University
Division name
Internal medicine 1
Zip code
693-8503
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2183
ken1nai@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken-chiro |
| Middle name | |
| Last name | Tanaka |
Organization
Shimane University
Division name
Internal medicine 1
Zip code
693-8503
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2183
Homepage URL
ken1nai@med.shimane-u.ac.jp
Sponsor or person
Institute
Internal medicine 1, Shimane University
Institute
Department
Personal name
Funding Source
Organization
Internal medicine 1, Shimane University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University
Address
Internal Medicine 1, Shimane University Faculty of Medicine, 89-1 Enya-cho
Tel
0853202183
ken1nai@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
| 2019 | Year | 10 | Month | 01 | 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
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Related factors between romosozumab, a sclerostin monoclonal antibody, and bone mineral density as well as bone turnover markers are very important in the treatment of osteopososis.
Management information
Registered date
| 2019 | Year | 09 | Month | 30 | Day |
Last modified on
| 2019 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043496
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
