UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of denosumab on healing of femoral trochanteric fracture and rehabilitation
Title of the study (Brief title)	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	Shigeharu Uchiyama
Organization	Okaya City Hospital
Division name	Orthopaedic Surgery
Address	Okaya
TEL	0266238000
Email	sigeuti@shinshu-u.ac.jp

Public contact
Name of contact person	Shigeharu Uchiyama
Organization	Okaya City Hospital
Division name	Orthopaedic Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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