UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of low-intensity pulsed ultrasound (LIPUS) against the atypical femur fractures assosiated with long term bisphosphonate use.
Title of the study (Brief title)	The effect of low-intensity pulsed ultrasound (LIPUS) against the atypical femur fractures.
Region	Japan

Condition
Condition	The atypical femur fractures associated with long-term bisphosphonate use
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect of Low-intensity pulsed ultrasound for The atypical femur fractures associated with long-term bisphosphonate use
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	bony union rate, bony union period, clinical outcomes
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	LIPUS
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	agree more than 20 years old more than 5 years use of bisphosphonate Xp: atypical subtrochanteric fractures or lateral cortical bone hypertrophy/transverse fracture line in femoral shaft Patients who received enough informed consent and understand and agree to the study
Key exclusion criteria	complete fracture was occur during study others
Target sample size	10

Research contact person
Name of lead principal investigator	Tomohiro Onodera
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Address	Kita 15, Nishi 7, Kita-ku, Sapporo
TEL	011-706-5935
Email	tomozou@med.hokudai.ac.jp

Public contact
Name of contact person	Tomohiro Onodera
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Address	Kita 15, Nishi 7, Kita-ku, Sapporo
TEL	011-706-5935
Homepage URL
Email	tomozou@med.hokudai.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Hokkaido University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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	2015 Year 04 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 28 Day
Anticipated trial start date	2014 Year 04 Month 28 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	2015 Year 04 Month 21 Day
Last modified on	2017 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019953