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Recruitment status Terminated
Unique ID issued by UMIN UMIN000011579
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email tnk_sny@saitama-med.ac.jp

Sponsor
Institute Saitama medical university
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013230


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