UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014221 |
|---|---|
| Receipt number | R000016564 |
| Scientific Title | Preventive efficacy for second hip fracture |
| Date of disclosure of the study information | 2014/06/30 |
| Last modified on | 2017/02/06 09:04:30 |
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Basic information
Public title
Preventive efficacy for second hip fracture
Acronym
TERIFIC study
Scientific Title
Preventive efficacy for second hip fracture
Scientific Title:Acronym
TERIFIC study
Region
| Japan |
Condition
Condition
Hip fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate secondary hip fracture risk reduction by therapeutic drug of osteoporosis including teriparatide.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of secondary hip fracture
Key secondary outcomes
Incidence of other fragility fracture, fracture healing, ADL, etc.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Patients with a first unilateral hip fracture.
2.Patient who can walk indoor before injury.
Key exclusion criteria
1.Patient with morbid fracture or fracture by high energy accident.
2.Patient with previous hip fracture.
3.Patient with previous osteoporosis treatment.
4.Patient who cannot walk indoor before injury.
5.Patient with sever dementia, hemiplegia, severe renal dysfunction.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Sawaguchi |
Organization
Toyama City Hospital
Division name
Department of Orthopedic Surgery
Zip code
Address
2-1 Imaizumi-hokubu, Toyama, Japan
TEL
076-422-1112
sawaguch@mxq.mesh.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Sasaki |
Organization
JCRSU.Co
Division name
TERIFIC study secretariat
Zip code
Address
6-29 Shinogawatyo Shinjuku-ku Tokyo, Japan
TEL
03-5946-8264
Homepage URL
terific@crsu.org
Sponsor or person
Institute
Japanese society for fracture repair
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Pharma Corporation
Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2014 | Year | 06 | Month | 30 | 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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Prospective study about second hip fracture
Management information
Registered date
| 2014 | Year | 06 | Month | 10 | Day |
Last modified on
| 2017 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016564
