UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003109 |
|---|---|
| Receipt number | 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 12:40:33 |
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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
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
kchiba@sc.itc.keio.ac.jp
Sponsor or person
Institute
Japanese Orthopaedic Association, Spine and Spinal Cord Disease Committee
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003773
