UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002114 |
|---|---|
| Receipt number | R000002576 |
| Scientific Title | Effect of bisphosphonate on healing of fragility distal radius fracture treated surgically. |
| Date of disclosure of the study information | 2009/06/23 |
| Last modified on | 2012/11/08 16:37:58 |
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Basic information
Public title
Effect of bisphosphonate on healing of fragility distal radius fracture treated surgically.
Acronym
Effect of bisphosphonate on healing of distal radius fracture
Scientific Title
Effect of bisphosphonate on healing of fragility distal radius fracture treated surgically.
Scientific Title:Acronym
Effect of bisphosphonate on healing of distal radius fracture
Region
| Japan |
Condition
Condition
fragility distal radius fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clairy if bisphosphonate adversely affects fracture healing both on X-ray and clnical examinations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bony healing on X-ray, ROM, grip strength, tenderness over the fracture site, QuickDASH score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bisphosphonate is prescribed within one week after surgery
Interventions/Control_2
Bisphosphonate is prescribed after 4months postoperatively.
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
fragility distal radius fracture
indication for ORIF using locking plate and screws
Key exclusion criteria
open fracture
accompanied by neurovascular complications
taking bisphosphonate before injury
systemic disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Uchiyama Shigeharu |
Organization
Shinshu University, School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
Asahi 3-1-1, Matsumoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shinshu University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
TEL
Homepage URL
sigeuti@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu Society for Upper Extremity Surgery
Institute
Department
Personal name
Funding Source
Organization
The Univers foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Community medicine foundation
Banyu Parmaceutical co.,LTD
Teijin Limited
JSSH research project
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 | 06 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
80 patients have been followed up for at least 4 months after surgery.
There has been no case of nonunion in both groups.
Some differences of radiographic parameters related to fracture healing process were detected.
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
| 2007 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2012 | Year | 10 | Month | 10 | Day |
Date analysis concluded
| 2012 | Year | 11 | Month | 11 | Day |
Other
Other related information
Bony union in the radiographs is evaluated by three independent observers, including two orthopaedic surgeons and one radiologist.
Management information
Registered date
| 2009 | Year | 06 | Month | 23 | Day |
Last modified on
| 2012 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002576
