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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009610
Receipt No. R000011273
Scientific Title Clinical study for reducing the risk of progress of idiopathic osteonecrosis of the femoral head (ION) by teriparatide treatment
Date of disclosure of the study information 2012/12/26
Last modified on 2017/09/01

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Basic information
Public title Clinical study for reducing the risk of progress of idiopathic osteonecrosis of the femoral head (ION) by teriparatide treatment
Acronym Risk reduction of progress of ION
Scientific Title Clinical study for reducing the risk of progress of idiopathic osteonecrosis of the femoral head (ION) by teriparatide treatment
Scientific Title:Acronym Risk reduction of progress of ION
Region
Japan

Condition
Condition idiopathic osteonecrosis of the femoral head
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the risk reduction of femoral head collapse of ION by teriparatide treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of femoral head collapse by X-ray film
Rate of osteotomy or hip arthroplasty
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Teriparatide Acetate
Interventions/Control_2 Normal treatment
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria: Patients with ION over 20 years old

Diagnosis of ION:
Two or more items that meet the following;
1.Femoral head collapse or subchondral fracture in femoral head observed by X-ray film
2.Cystic and sclerotic changes in femoral head by X-ray film
3.Cold in hot image in femoral head by scintigraphy
4.Bone necrosis with repair reaction by bone biopsy
5.Band pattern in femoral head by MRI
Key exclusion criteria 1.Patients with contraindication of teriparatide
2.Patient who was not obtained informed consent
3.Hips already receiving osteotomy or hip arthroplasty by ION
4.Patients with severe renal dysfunction, hepatic dysfunction, and cardiac dysfunction
5.Hips with osteoarthritis changes
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromasa Tanino
Organization Asahikawa Medical University
Division name Department of Orthopaedic Surgery
Zip code
Address Midorigaoka Higashi 2-1-1-1, Asahikawa city, 078-8510
TEL 0166652111
Email taninohiromasa@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiromasa Tanino
Organization Asahikawa Medical University
Division name Department of Orthopaedic Surgery
Zip code
Address Midorigaoka Higashi 2-1-1-1, Asahikawa city, 078-8510
TEL 0166652111
Homepage URL
Email taninohiromasa@hotmail.com

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Asahikawa Medical University
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

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 26 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
2012 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 26 Day
Last follow-up date
2017 Year 08 Month 24 Day
Date of closure to data entry
2017 Year 09 Month 01 Day
Date trial data considered complete
2017 Year 09 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 12 Month 21 Day
Last modified on
2017 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011273

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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