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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002274
Receipt No. 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

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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
Email

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
Email twada@sapmed.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Sapporo Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002573

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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