UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016345 |
|---|---|
| Receipt number | R000018967 |
| Scientific Title | To clarify the effects of anti-osteoporosis drugs on preventing patients from areterial calcification. A multicentric study. |
| Date of disclosure of the study information | 2015/02/10 |
| Last modified on | 2019/07/31 16:00:11 |
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Basic information
Public title
To clarify the effects of anti-osteoporosis drugs on preventing patients from areterial calcification. A multicentric study.
Acronym
The effects of anti-osteoporosis drugs on prevention of areterial calcification
Scientific Title
To clarify the effects of anti-osteoporosis drugs on preventing patients from areterial calcification. A multicentric study.
Scientific Title:Acronym
The effects of anti-osteoporosis drugs on prevention of areterial calcification
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Geriatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is conducted to clarify difference of extents of areterial cacification between osteoporsis patients with treatments and without treatment.
Basic objectives2
Others
Basic objectives -Others
To clarify the secondary effects of anti-soteoporotic drugs
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Whether there are differences of calcification in aorta, abdominal aretery, or iliac artery between osteoporosis patients with treatmets and without treatment
Key secondary outcomes
1. Wheter there are correlation between severity of osteoporosis and severity of arterial calcification.
2. Wheter there are different effects of anti-osteoporotic drugs on prevention of arterial calcification
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with primary osteoporosis, compatible to Japanese criteron of primary osteoporosis a revised edition in 2012.
2. Patients with glucocorticod induced osteoporosis, compatible to guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese society of bone and mineral research, 2014 update.
Key exclusion criteria
1. Metabolic bone diseases other than osteoporosis
2. Serious renal, hepatic, or cardiac disease
3. Patients who are considered appropriate for enrollement by the investigator.
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
Orthopaedic surgery
Zip code
Address
38, Morohongo, Moroyama-cho, Iruma-gun, Saitama
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
Orthopaedic surgery
Zip code
Address
38, Morohongo, Moroyama-cho, Iruma-gun, Saitama
TEL
+81-49-276-1238
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
Akita university
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 10 | 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
| 2015 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 09 | 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
Nothing
Management information
Registered date
| 2015 | Year | 01 | 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=R000018967
