This study is designed to evaluate long term efficacy of intravenous bisphosphonates for bone marrow edema in patients with SAPHO syndrome.
The study will evaluate the long term efficacy at 3 days, 3 and 6 months after pamidronate disodium administered. Patients will be administered pamidronate disodium 1 mg/kg, IV, QD, for 3 days, and every 3 months (up to month 6).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
the patients will be administered pamidronate disodium 1 mg/kg, IV, QD, for 3 days, and every 3 month (up to month 6)
response to the treatment by the change of MRI result at screening, baseline, month 3 and month 6
Time frame: 3 and 6 month (up to 6 month)
physician's global assessment of disease activity at screening, baseline, month 3 and month 6
Time frame: 3 days, 3 and 6 month (up to 6 month)
response to the treatment by the change of Visual Analogue ale/Score (VAS) at screening, baseline, month 3 and month 6
Time frame: 3 days, 3 and 6 month (up to 6 month)
response to the treatment by the change of bath ankylosing spondylitis disease activity index (BASDAI) at screening, baseline, month 3 and month 6
Time frame: 3 days, 3 and 6 month (up to 6 month)
response to the treatment by the change of bath ankylosing spondylitis functional index (BASFI) at screening, baseline, month 3 and month 6
Time frame: 3 days, 3 and 6 month (up to 6 month)
response to the treatment by the change of bath ankylosing spondylitis metroloty index (BASMI) at screening, baseline, month 3 and month 6
Time frame: 3 days, 3 and 6 month (up to 6 month)
response to the treatment by the change of ankylosing spondylitis disease activity score (ASDAS) at screening, baseline, month 3 and month 6
Time frame: 3 days, 3 and 6 month (up to 6 month)
response to the treatment by the change of erythrocyte sedimentation rate (ESR) at screening, baseline, month 3 and month 6
Time frame: 3 days, 3 and 6 month (up to 6 month)
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response to the treatment by the change of high sensitivity-C reaction protein (hs-CRP) at screening, baseline, month 3 and month 6
Time frame: 3 days, 3 and 6 month (up to 6 month)
response to the treatment by the change of Osteocalcin at screening, baseline, month 3 and month 6
Time frame: 3 days, 3 and 6 month (up to 6 month)
response to the treatment by the change of beta-Crosslaps (beta-CTx) at screening, baseline, month 3 and month 6
Time frame: 3 days, 3 and 6 month (up to 6 month)