Effect of Calcitonin Preparation for Acute Low Back Pain of Osteoporotic Fresh Vertebral Compression Fracture

UMIN ID: UMIN000001757

Registered date:05/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• 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
• Secondary Outcome: VAS(visual analogue scale):pain scale RDQ:Roland Morris Disability Questionnaire

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: Not applicable
• Gender: Female
• 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
• Source(s) of Monetary Support: Japanese Society for Musclo-skeletal Rehabilitation