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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001757
Receipt No. R000002114
Scientific Title Effect of Calcitonin Preparation for Acute Low Back Pain of Osteoporotic Fresh Vertebral Compression Fracture
Date of disclosure of the study information 2009/03/05
Last modified on 2009/10/05

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Basic information
Public title Effect of Calcitonin Preparation for Acute Low Back Pain of Osteoporotic Fresh Vertebral Compression Fracture
Acronym Effect of Calcitonin Preparation for Acute Low Back Pain of Osteoporotic Fresh Vertebral Compression Fracture
Scientific Title Effect of Calcitonin Preparation for Acute Low Back Pain of Osteoporotic Fresh Vertebral Compression Fracture
Scientific Title:Acronym Effect of Calcitonin Preparation for Acute Low Back Pain of Osteoporotic Fresh Vertebral Compression Fracture
Region
Japan

Condition
Condition Osteoporotic lower back pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the efficacy of elcatonin and oral NSAIDs in patients with osteoporosis who report acute low back pain of fresh vertebral compression fracture.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Effect of QOL(JSEQ) for pain
Key secondary outcomes VAS(visual analogue scale):pain scale
RDQ:Roland Morris Disability Questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 elcatonin
Interventions/Control_2 oral Nonsteroidal anti-inflammatory drugs(NSAIDs)
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
65 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Subjects are eligible for the study if they meet all the following criteria and give written informed consent for the study:
1) Women 65 years or older
2) Patients in whom acute low back pain developed within the past 2 weeks
3)Patients in whom a new fragile fracture of the thoracolumbar vertebra developed
*Subjects who report acute low back pain
*Pain is severe with body movement, but there is no or very little pain at rest.
*Percussion tenderness is observed.
4) Outpatients who understand the purpose of this clinical study
Key exclusion criteria 1) Secondary osteoporosis
2) Surgery for thoracolumbar vertebra
3) Obvious neurological deficit associated with spinal disease
4) Severe scoliosis
5) Patients in whom study drugs (calcitonin, NSAIDs) are contraindicated
6)Infectious spinal disease
7)Patients who have received NSAIDs continuously within 3 days before the start of this clinical study
8) Serious renal, hepatic, or cardiac disease
9)Treatment for malignant tumor
10)Patients who are considered inappropriate for enrollment by the investigator for any other reason
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiji Fujino
Organization Fujino orthopedic clinic
Division name director
Zip code
Address Jhouhoku 2-15-12, nakaku,Hamamatusi, Shizuokaken, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keiji Fujino
Organization Fujino orthopedic clinic
Division name director
Zip code
Address Jhouhoku 2-15-12, nakaku,Hamamatusi, Shizuokaken, Japan.
TEL 053-471-4196
Homepage URL
Email

Sponsor
Institute Japanese Society for Musclo-skeletal Rehabilitation
Institute
Department

Funding Source
Organization Japanese Society for Musclo-skeletal Rehabilitation
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 05 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 Completed
Date of protocol fixation
2008 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 05 Day
Last modified on
2009 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002114

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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