UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preventive efficacy for second hip fracture
Title of the study (Brief title)	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	Takeshi Sawaguchi
Organization	Toyama City Hospital
Division name	Department of Orthopedic Surgery
Address	2-1 Imaizumi-hokubu, Toyama, Japan
TEL	076-422-1112
Email	sawaguch@mxq.mesh.ne.jp

Public contact
Name of contact person	Masao Sasaki
Organization	JCRSU.Co
Division name	TERIFIC study secretariat
Address	6-29 Shinogawatyo Shinjuku-ku Tokyo, Japan
TEL	03-5946-8264
Homepage URL
Email	terific@crsu.org

Sponsor
Institute	Japanese society for fracture repair
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016564