None listed
Conditions
Interventions
Drug : ibandronate 150mg or placebo every 4weeks, total 48weeks
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Rheumatoid arthritis fulfilling the 1987 ACR criteria 2. Women equal and above 18 years, less than 75 years old 3. L1-4 T score less than -1.0 and equal or above -3.0 SD measured by DXA (Dual Energy X-ray Absorptiometry) 4. Patient who has taken prednisolone 5mg or its equivalent for more than 3 consecutive months within 1 year and will be taking it for more than 3 months after enrollment 5. Patient who has signed the consent form
Exclusion criteria
Exclusion criteria: 1. Patient with more than 1 vertebral fracture at the time of screening (fractures due to trauma are allowed) 2. Patient with nonvertebral fracture associated with osteoporosis 3. Patient unable to do DXA owing to vertebral deformity 4. History or present illness of bone metabolism such as osteomalacia, Paget's disease 5. History or present illness of upper gastrointestinal tract 6. History or present illness of malabsorption 7. Patient diagnosed with malignancy within 5 years 8. History or present illness of endocrine dysfunction 9. Patient undergoing thyroid hormone replacement: TSH10.0mIU/L 10. History or present illness of gonandal dysfunction 11. Patient who has received a transplant 12. History or present illness of multiple myeloma, lymphoma, leukemia or hemolytic anemia 13. Patient with RA functional class 4 14. Patient who cannot sit up straight for 60 minutes 15. Patient who has hypersensitivity to ibandronate 16. Patient who participated in other clinical studies within a month 17. Patient who received medication affecting bone turnover within 24 hours of screening 18. Positive urine ß-hCG 19. AST, ALT elevation more than 2 times the normal limit 20. Impaired renal function (Creatinine clearance 11.0 mg/dL or < 8.0 mg/dL 22. Patient with nephrolithiasis 23. Patient who cannot tolerate calcium and vitamin D PO medication 24. History or present illness of alcohol or drug abuse, or present illness of psychiatric disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of BMD changes in L1-4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Ratio of BMD changen in total hip or femur neck;Ratio of changes in bone turn over markers | — |
Countries
Korea, Republic of
Contacts
Public ContactKichul Shin
Seoul National University Hospital
Outcome results
None listed