UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008979 |
|---|---|
| Receipt number | R000010530 |
| Scientific Title | effect of biochemical markers of bone turnover for treating and predicting fracture risk risk of metabolic bone disease |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2012/09/25 18:41:34 |
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Basic information
Public title
effect of biochemical markers of bone turnover for treating and predicting fracture risk risk of metabolic bone disease
Acronym
effect of biochemical markers of bone turnover for treating and predicting fracture risk risk of metabolic bone disease
Scientific Title
effect of biochemical markers of bone turnover for treating and predicting fracture risk risk of metabolic bone disease
Scientific Title:Acronym
effect of biochemical markers of bone turnover for treating and predicting fracture risk risk of metabolic bone disease
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether bone turnover markers reflect the long-term therapeutic effect and whether bone turnover markers predict fracture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
new fracture
Key secondary outcomes
changes of biochemical markers of bone turnover and changes of the bone mineral density in lumbar and hip
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
given bisphosphonate in patient
Interventions/Control_2
Given the 60 mg once daily Raloxifene
in patients
Interventions/Control_3
given the 0.5-1g once daily active type Vitamin D in patient
Interventions/Control_4
receive 45 mg/day treatment of menatetrenone (MK-4)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
osteoporosis and metabolic bone disease
Key exclusion criteria
The patient who has been already treated with medicine for osteoporosis
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takami Miki |
Organization
Osaka City University Graduate School of Medicine
Division name
Gerontology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka Japan
TEL
06-6645-3889
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Masaki |
Organization
Osaka City University Graduate School of Medicine
Division name
Gerontology
Zip code
Address
TEL
Homepage URL
h-masaki@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2012 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 25 | Day |
Last modified on
| 2012 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010530
