UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031971 |
|---|---|
| Receipt number | R000036502 |
| Scientific Title | Effect of denosumab on healing of femoral trochanteric fracture and rehabilitation |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/03/29 12:39:22 |
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Basic information
Public title
Effect of denosumab on healing of femoral trochanteric fracture and rehabilitation
Acronym
Denosumab and fracture healing
Scientific Title
Effect of denosumab on healing of femoral trochanteric fracture and rehabilitation
Scientific Title:Acronym
Denosumab and fracture healing
Region
| Japan |
Condition
Condition
femoral trochnanteric fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of early administration of denosumab on healing of femoral trochanteric fracture by quantitating callus formation on CT iamges
Basic objectives2
Others
Basic objectives -Others
postoperative rehab
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Callus formation at postoperative 1,2 and 3 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Denosumab 60ug
subcutaneous injection within one week after surgery
1,25OHD within one week after surgery
Interventions/Control_2
bisphosphonate monthly drug
1,25OHD within one week after surgery
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
femoral trochanteric fracture
Key exclusion criteria
open fracture
multiple injuries
major nerves or vessels injury
bedridden
under osteoporotic treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeharu Uchiyama |
Organization
Okaya City Hospital
Division name
Orthopaedic Surgery
Zip code
Address
Okaya
TEL
0266238000
sigeuti@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeharu Uchiyama |
Organization
Okaya City Hospital
Division name
Orthopaedic Surgery
Zip code
Address
Okaya City
TEL
+81263373095
Homepage URL
sigeuti@shinshu-u.ac.jp
Sponsor or person
Institute
Okaya City Hospital
Institute
Department
Personal name
Funding Source
Organization
Okaya City Hospital
Organization
Division
Category of Funding Organization
Local Government
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2018 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036502
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
