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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031971
Receipt No. 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

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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
Email 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
Email sigeuti@shinshu-u.ac.jp

Sponsor
Institute Okaya City Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036502

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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