UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study for reducing the risk of progress of idiopathic osteonecrosis of the femoral head (ION) by teriparatide treatment
Title of the study (Brief title)	Risk reduction of progress of ION
Region	Japan

Condition
Condition	idiopathic osteonecrosis of the femoral head
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the risk reduction of femoral head collapse of ION by teriparatide treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of femoral head collapse by X-ray film Rate of osteotomy or hip arthroplasty
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	Teriparatide Acetate
Interventions/Control_2	Normal treatment
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	Inclusion criteria: Patients with ION over 20 years old Diagnosis of ION: Two or more items that meet the following; 1.Femoral head collapse or subchondral fracture in femoral head observed by X-ray film 2.Cystic and sclerotic changes in femoral head by X-ray film 3.Cold in hot image in femoral head by scintigraphy 4.Bone necrosis with repair reaction by bone biopsy 5.Band pattern in femoral head by MRI
Key exclusion criteria	1.Patients with contraindication of teriparatide 2.Patient who was not obtained informed consent 3.Hips already receiving osteotomy or hip arthroplasty by ION 4.Patients with severe renal dysfunction, hepatic dysfunction, and cardiac dysfunction 5.Hips with osteoarthritis changes
Target sample size	50

Research contact person
Name of lead principal investigator	Hiromasa Tanino
Organization	Asahikawa Medical University
Division name	Department of Orthopaedic Surgery
Address	Midorigaoka Higashi 2-1-1-1, Asahikawa city, 078-8510
TEL	0166652111
Email	taninohiromasa@hotmail.com

Public contact
Name of contact person	Hiromasa Tanino
Organization	Asahikawa Medical University
Division name	Department of Orthopaedic Surgery
Address	Midorigaoka Higashi 2-1-1-1, Asahikawa city, 078-8510
TEL	0166652111
Homepage URL
Email	taninohiromasa@hotmail.com

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	Asahikawa Medical University
Organization
Division
Category of Funding Organization	Self funding
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	2012 Year 12 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 28 Day
Anticipated trial start date	2012 Year 12 Month 26 Day
Last follow-up date	2017 Year 08 Month 24 Day
Date of closure to data entry	2017 Year 09 Month 01 Day
Date trial data considered complete	2017 Year 09 Month 01 Day
Date analysis concluded

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

Management information
Registered date	2012 Year 12 Month 21 Day
Last modified on	2017 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011273