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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003109
Receipt No. R000003773
Scientific Title Prospective clinical trial to establish optimal strategy of conservative management for osteoporotic vertebral fractures
Date of disclosure of the study information 2010/02/01
Last modified on 2011/01/28

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Basic information
Public title Prospective clinical trial to establish optimal strategy of conservative management for osteoporotic vertebral fractures
Acronym Prospective study on different conservative managements for osteoporotic vertebral fractures
Scientific Title Prospective clinical trial to establish optimal strategy of conservative management for osteoporotic vertebral fractures
Scientific Title:Acronym Prospective study on different conservative managements for osteoporotic vertebral fractures
Region
Japan

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

Objectives
Narrative objectives1 To establish an optimal treatment strategy for acute osteoporotic vertebral fractures, outcomes of different conservative treatments will be compared prospectively.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes bone union, development of pseudoarthorosis, progression of vertebral compression on plain radiogarphs
Key secondary outcomes assessment of pain (visual analog scale), neurological functions, SF-36, bone density (DXA)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 3 weeks bed rest followed by 9 weeks of semi-rigid brace wear.
Interventions/Control_2 After, immediate ambulation, 4 weeks plaster cast fixation, followed by 4 weeks semi-rigid brace, then, 4 weeks ready-made corset wear.
Interventions/Control_3 Immediate ambulation, followed by 12 weeks ready-made corset wear.
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
90 years-old >
Gender Female
Key inclusion criteria 1. Female between 65 and 90 years of age
2. Sustained a vertebral fracture between T11 and L2 level
3. Clear diagnosis of vertebral fracture can be established on plain radiographs and MRI
4. Satisfies diagnositic criteria for idiopathic osteoporosis
5. Has no motor paralysis
6. Written consent can be obtain from herself or a family member
Key exclusion criteria Patient who
1. has pathological fracture
2. has malignancies
3. has participated in a different trail on osteoporosis within 6 months
4. is unable to undergo MRI
5. had been unable to walk before injury
6. has unhealed previous vertebral fractures
7. has demintia
8. is judged inappropriate to participate in this study by the investigators
8. has severe general complications that hampers proper rehabilitation
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensei Nagata
Organization Kurume University School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 67 Asahicho, Kurume, Fukuoka, Japan
TEL 0942-35-3311
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Chiba
Organization School of Medicine, Keio University
Division name Department of Orthopaedic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL 03-5363-3812
Homepage URL
Email kchiba@sc.itc.keio.ac.jp

Sponsor
Institute Japanese Orthopaedic Association, Spine and Spinal Cord Disease Committee
Institute
Department

Funding Source
Organization Japanese Orthopaedic Association
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 久留米大学病院(福岡)、東京医科歯科大学病院(東京)、杏林大学病院(東京)、福島県立医科大学病院(福島)、慶應義塾大学病院(東京)、関西医科大学病院(大阪)、福井大学医学部付属病院(福井)、山口大学医学部付属病院(山口)、東北中央病院(宮城)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Introduction: Optimal conservative management for acute thoracolumbar osteoporotic vertebral compression fractures (VCF) are still under debate. This multicenter prospective RCT was undertaken to verify optimal treatment protocol for VCF. Methods: Patients with acute osteoporotic VCF who visited participating hospitals were enrolled. Inclusion criteria were 1) 65 to 90 y/o female; 2) fractures between T11 and L2; 3) those without neurological deficits. Diagnosis of VCF was established by X-ray and MRI. Pathological fractures and those with significant canal compromise were excluded. Patients were randomly assigned to one of three treatment groups. Group 1: 3 weeks bed rest followed by semirigid brace, Group 2: early mobilization with cast, followed by semirigid brace then simple corset, and Group 3: early mobilization with simple brace only. External supports were continued until 12 weeks post-injury. Rate of nonunion, progression of vertebral deformity, pain, SF-36 and neurological status were compared among three groups. Results: Forty-three patients were included and 14, 15, and 14 patients were assigned to each group. Nonunion rates were not significantly different among three groups, however, union tended to be delayed in Group 1. Most vertebral deformity occurred between 4-8 weeks, and none of treatments could prevent vertebral deformity completely. Vertebral wedge rate and Social Function score of SF-36 were significantly superior in Group 2 than 1. There were no other parameters that were significantly different among three groups. Discussion: This is first RCT comparing clinical and radiological results of different conservative treatments for patients with VCF. Prolonged bed rest did not prevent vertebral deformity nor improved clinical results, therefore, early mobilization is justified. Although complete prevention of deformity progression was not possible, rigid external support may be favored over simple corset.
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
2007 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 08 Month 01 Day
Date trial data considered complete
2010 Year 10 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 28 Day
Last modified on
2011 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003773

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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