Unique ID issued by UMIN | UMIN000001757 |
---|---|
Receipt number | 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 19:35:05 |
Effect of Calcitonin Preparation for Acute Low Back Pain of Osteoporotic Fresh Vertebral Compression Fracture
Effect of Calcitonin Preparation for Acute Low Back Pain of Osteoporotic Fresh Vertebral Compression Fracture
Effect of Calcitonin Preparation for Acute Low Back Pain of Osteoporotic Fresh Vertebral Compression Fracture
Effect of Calcitonin Preparation for Acute Low Back Pain of Osteoporotic Fresh Vertebral Compression Fracture
Japan |
Osteoporotic lower back pain
Orthopedics |
Others
NO
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.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
Effect of QOL(JSEQ) for pain
VAS(visual analogue scale):pain scale
RDQ:Roland Morris Disability Questionnaire
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
elcatonin
oral Nonsteroidal anti-inflammatory drugs(NSAIDs)
65 | years-old | <= |
Not applicable |
Female
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
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
300
1st name | |
Middle name | |
Last name | Keiji Fujino |
Fujino orthopedic clinic
director
Jhouhoku 2-15-12, nakaku,Hamamatusi, Shizuokaken, Japan.
1st name | |
Middle name | |
Last name | Keiji Fujino |
Fujino orthopedic clinic
director
Jhouhoku 2-15-12, nakaku,Hamamatusi, Shizuokaken, Japan.
053-471-4196
Japanese Society for Musclo-skeletal Rehabilitation
Japanese Society for Musclo-skeletal Rehabilitation
Self funding
Japan
NO
2009 | Year | 03 | Month | 05 | Day |
Unpublished
Completed
2008 | Year | 07 | Month | 12 | Day |
2008 | Year | 07 | Month | 01 | Day |
2009 | Year | 06 | Month | 01 | Day |
2009 | Year | 03 | Month | 05 | Day |
2009 | Year | 10 | Month | 05 | Day |
Value
https://center6.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 |