UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011579 |
|---|---|
| Receipt number | R000013230 |
| Scientific Title | A cohort study of osteoporosis with treatments |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2019/07/31 16:15:01 |
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Basic information
Public title
A cohort study of osteoporosis with treatments
Acronym
Moroyama cohort
Scientific Title
A cohort study of osteoporosis with treatments
Scientific Title:Acronym
Moroyama cohort
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify effective threpies on prevention of fractures, increases of BMD, and improving QOL
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Prevention of fractures
2. Increases of BMD
3. Improving QOL
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients sufferd from osteoporosis.
Key exclusion criteria
Illiterate persons
Patients with sever complications
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Tanaka |
Organization
Saitama medical university
Division name
Department of orthopaedic surgery
Zip code
Address
Morohongo 38, Moroyama-cho, Iruma-gun
TEL
+81-49-276-1238
tnk_sny@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Tanaka |
Organization
Saitama medical university
Division name
Department of orthopaedic surgery
Zip code
Address
Morohongo 38, Moroyama-cho, Iruma-gun
TEL
049-276-1238
Homepage URL
tnk_sny@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university
Institute
Department
Personal name
Funding Source
Organization
None
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
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
埼玉医科大学病院（埼玉県）
あずまリウマチクリニック（埼玉県）
関越病院（埼玉県）
埼玉慈恵病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to clarify the best protocol to prevent fractures, increase BMD, and improve QOL with osteoporotic patients, by mean of analysis of detabase.
Management information
Registered date
| 2013 | Year | 08 | Month | 26 | Day |
Last modified on
| 2019 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013230
| 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 |
