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

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 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


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

Value
https://center6.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