UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002274 |
|---|---|
| Receipt number | R000002573 |
| Scientific Title | Clinical trial on preventive effect of calcitonin to Complex Regional Pain Syndrome (CRPS) associated with distal radius fracture |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2014/04/09 15:17:15 |
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Basic information
Public title
Clinical trial on preventive effect of calcitonin to Complex Regional Pain Syndrome (CRPS) associated with distal radius fracture
Acronym
Preventive effect of calcitonin to CRPS associated with distal radius fracture
Scientific Title
Clinical trial on preventive effect of calcitonin to Complex Regional Pain Syndrome (CRPS) associated with distal radius fracture
Scientific Title:Acronym
Preventive effect of calcitonin to CRPS associated with distal radius fracture
Region
| Japan |
Condition
Condition
distal radius fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the preventive effect of calcitonin to complex regional pain syndrome associated with distal radius fracture by randomized controled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the presence of complex regional syndrome at any time within three months after the fracture
Key secondary outcomes
Pain and function after the fracture
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intervention group: Patients receive 4 intramuscular injections of 20U of elcatonin weekly.
Interventions/Control_2
Control group: Only treatment and rehabilitation for distal radius fracture is performed.
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women aged 45 years and over.
Distal radius fracture occurring as fragility fracture.
AO/ASIF classification 23-A, B , and C.
Patients who are seen in each hospital within 7 days after fracture.
Patients willing to participate in this study.
Key exclusion criteria
CRPS at presentation or past history of CRPS.
Administration of elcatonin before fracture.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuro Wada |
Organization
Sapporo Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
South 1, West 16, Chuo-ku, Sapporo
TEL
011-611-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuro Wada |
Organization
Sapporo Medicak University
Division name
Department of Orthopaedic Surgery
Zip code
Address
TEL
011-611-2111
Homepage URL
twada@sapmed.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Sapporo 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
| 2009 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 31 | Day |
Last modified on
| 2014 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002573
