UMIN-CTR Clinical Trial

Basic information
Public title	The optimal treatment for fresh osteoporotic vertebral fracture with poor prognostic MRI findings
Acronym	The optimal treatment for fresh OVF with poor prognostic MRI findings
Scientific Title	The optimal treatment for fresh osteoporotic vertebral fracture with poor prognostic MRI findings
Scientific Title:Acronym	The optimal treatment for fresh OVF with poor prognostic MRI findings
Region	Japan

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

Objectives
Narrative objectives1	To investigate whether a conservative treatment with initial bed rest prevents from vertebral collapse progression and decrease surgical cases in fresh OVF
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of conservative treatment failure within 6 months.
Key secondary outcomes	Fusion rate, progression of vertebral collapse, progression of local kyphosis, decrease in activity of daily living

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	60 years-old <=
Age-upper limit	110 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who begins to receive conservative treatment within 2 weeks after injury.
Key exclusion criteria	Secondary osteoporosis patients, high energy injury
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Funayama
Organization	University of Tsukuba
Division name	Orthopaedic Surgery
Zip code	3058575
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-3219
Email	funatoru3@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Funayama
Organization	University of Tsukuba
Division name	Orthopaedic Surgery
Zip code	3058575
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-3219
Homepage URL
Email	funatoru3@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Japan Osteoporosis Society
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tsukuba Clinical Research & Development Organization
Address	2-1-1 Amakubo, Tsukuba, Ibaraki
Tel	029-853-3914
Email	t-credo.adm@un.tsukuba.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	2021 Year 10 Month 10 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	82
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	Completed
Date of protocol fixation	2018 Year 10 Month 25 Day
Date of IRB	2018 Year 10 Month 25 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2022 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The rate of conservative treatment failure, fusion rate, progression of vertebral collapse, progression of local kyphosis and decrease of activity of daily living will be investigated.

Management information
Registered date	2021 Year 10 Month 02 Day
Last modified on	2022 Year 10 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052107