UMIN-CTR Clinical Trial

Basic information
Public title	Neurological deficit associated with osteoporotic vertebral fracture: evaluation of clinical features from a prospective multicenter study
Acronym	Neurological deficit associated with osteoporotic vertebral fracture: a prospective multicenter study
Scientific Title	Neurological deficit associated with osteoporotic vertebral fracture: evaluation of clinical features from a prospective multicenter study
Scientific Title:Acronym	Neurological deficit associated with osteoporotic vertebral fracture: a prospective multicenter study
Region	Japan

Condition
Condition	Osteoporotic vertebral fracture
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the clinical characteristics in epidemiology, symptoms and radiological findings in patients with osteoporotic vertebral fracture associated with neurological deficit
Basic objectives2	Others
Basic objectives -Others	Analysis of clinical features of osteoporotic vertebral fracture causing neurological deficit
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patients' background Symptoms and neurological findings Imaging findings
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Investigation of patients' background, symptoms, neurological deficits and imaging findings on plain x-ray, CT and MRI of the spine. The investigation will be performed in patients having osteoporotic vertebral fracture associated with neurological deficit.
Interventions/Control_2	Investigation of patients' background, symptoms, neurological deficits and imaging findings on plain x-ray, CT and MRI of the spine. The investigation will be performed in patients having osteoporotic vertebral fracture without neurological deficit.
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion criteria of patients with neurological deficit: 1. having osteoporotic vertebral fracture 2. having neurological symptom due to the fracture 3. having neurological sign 4. the neurological disturbance caused at the fracture site or at the upper or lower adjacent intervertebral level 5. regardless of presence of degenerative change in the lumbar spine such as spondylolisthesis and spinal canal narrowing 6. regardless of the treatment method Inclusion criteria of patients without neurological deficit is to meet the criteria 1, 5 and 6 but not 2, 3, or 4 in above.
Key exclusion criteria	i) Neurological disturbance caused from other factor than ii) the fracture iii) Fracture united and healed completely iv) Secondary osteoporosis v) Incapability of the imaging examination vi) Without the patient's consent
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Haruo Middle name Last name Kanno
Organization	Tohoku University Hospital
Division name	Department of Orthopaedic Surgery
Zip code	9808574
Address	1-1 Seiryo-machi Aoba-ku Sendai
TEL	022-717-7245
Email	kanno-h@isis.ocn.ne.jp

Public contact
Name of contact person	1st name Haruo Middle name Last name Kanno
Organization	Tohoku University Hospital
Division name	Department of Orthopaedic Surgery
Zip code	9808574
Address	1-1 Seiryo-machi Aoba-ku Sendai
TEL	022-717-7245
Homepage URL
Email	kanno-h@isis.ocn.ne.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Tohoku University school of Medicine
Institute
Department

Funding Source
Organization	Department of Orthopaedic Surgery, Tohoku University school of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Independent Ethics Committee of Tohok University School of Medicine
Address	1-1 Seiryo-machi Aoba-ku Sendai
Tel	022-717-8007
Email	med-kenkyo@bureau.tohoku.ac.jp

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 05 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	2016 Year 12 Month 22 Day
Date of IRB	2016 Year 12 Month 22 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 04 Month 30 Day
Last modified on	2021 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019163