UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009610 |
|---|---|
| Receipt number | 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 14:55:16 |
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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
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
taninohiromasa@hotmail.com
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011273
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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