UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015903 |
|---|---|
| Receipt number | R000018510 |
| Scientific Title | Evaluation of the efficacy of teriparatide for distal radial fracture repair after plate fixation in osteoporotic patients:A prospective randomized control study. |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2019/02/18 17:34:06 |
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Basic information
Public title
Evaluation of the efficacy of teriparatide for distal radial fracture repair after plate fixation in osteoporotic patients:A prospective randomized control study.
Acronym
Evaluation of the efficacy of teriparatide for fracture repair.
Scientific Title
Evaluation of the efficacy of teriparatide for distal radial fracture repair after plate fixation in osteoporotic patients:A prospective randomized control study.
Scientific Title:Acronym
Evaluation of the efficacy of teriparatide for fracture repair.
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of teriparatide for acceleration of fracture repair in osteoporotic patient with distal radial fractures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcome is the comparison of the percent chage of bone mineral density (BMD)of the fracture site as measured by dual-energy x-ray absorptiometry(DEXA)with or without teriparatide administration from baseline to 24 weeks after surgery.
Key secondary outcomes
Secondary outcome is the comparison of the percent change in markers of bone formation and resorption with or without teriparatide administration from baseline to 24 weeks after surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Teriparatide 20 microg is administrated subcutaneously once daily for 24 weeks.
Interventions/Control_2
Active vitamine D3 1.0 microg is orally administrated once daily for 24 weeks.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Distal radial fracture with surgical treatment
2)Gender:any gender
3)Age:any ages but correspond with diagnostic criteria for primary osteoporosis
4)Cases who have ability to consent to the study
5)case expected to attend a hospital regularly as planned
Key exclusion criteria
1)Primary malignant bone tumors or bone metastasis
2)Metabolic bone disease except primary osteoporosis
3)Under medication for osteoporosis(bisphosphonates, teriparatide, or SERM )
4)Under medication of steroid
5)Hypercalcemia
6)Suspection of metal allergy
7)Dementia, Schizophrenia, Panic disorder and other diseases that may have affect the evaluation or obstruct obtaining consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohiko Ota |
Organization
Yokohama City University Medical Center
Division name
Orthopaedics
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
ota_1080@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohiko Ota |
Organization
Yokohama City University Medical Center
Division name
Orthopaedics
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
ota_1080@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 10 | Day |
Last modified on
| 2019 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018510
