UMIN ID: UMIN000001757
Registered date:05/03/2009
Effect of Calcitonin Preparation for Acute Low Back Pain of Osteoporotic Fresh Vertebral Compression Fracture
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Osteoporotic lower back pain |
Date of first enrollment | 2008/07/01 |
Target sample size | 300 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | elcatonin oral Nonsteroidal anti-inflammatory drugs(NSAIDs) |
Outcome(s)
Primary Outcome | Effect of QOL(JSEQ) for pain |
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Secondary Outcome | VAS(visual analogue scale):pain scale RDQ:Roland Morris Disability Questionnaire |
Key inclusion & exclusion criteria
Age minimum | 65years-old |
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Age maximum | Not applicable |
Gender | Female |
Include criteria | |
Exclude 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 |
Related Information
Primary Sponsor | Japanese Society for Musclo-skeletal Rehabilitation |
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Secondary Sponsor | |
Source(s) of Monetary Support | Japanese Society for Musclo-skeletal Rehabilitation |
Secondary ID(s) |
Contact
public contact | |
Name | Keiji Fujino |
Address | Jhouhoku 2-15-12, nakaku,Hamamatusi, Shizuokaken, Japan. Japan |
Telephone | 053-471-4196 |
Affiliation | Fujino orthopedic clinic director |
scientific contact | |
Name | Keiji Fujino |
Address | Jhouhoku 2-15-12, nakaku,Hamamatusi, Shizuokaken, Japan. Japan |
Telephone | |
Affiliation | Fujino orthopedic clinic director |