Clinical Trial: Efficacy of Bisphosphonates in Patients With Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Unrandomized, Open Label Single-center Study to Assess the Long Term Efficacy of Intravenous Bisphosphonates for Bone Marrow Edema in Patients With SAPHO Syndrome
Brief Summary: This study is designed to evaluate long term efficacy of intravenous bisphosphonates for bone marrow edema in patients with SAPHO syndrome.
Detailed Summary: 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).
Sponsor: Peking Union Medical College Hospital
Current Primary Outcome: 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) ]
Original Primary Outcome: response to the treatment by the change of Visual Analogue ale/Score (VAS) [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
Current Secondary Outcome:
- 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) ]
- 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) ]
Original Secondary Outcome:
- physician's global assessment of disease activity at screening, baseline, and month 3 [ 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, and month 3 [ 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, and month 3 [ 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, and month 3 [ 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, and month 3 [ 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, and month 3 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
- response to the treatment by the change of high sensitivity-C reaction protein (hs-CRP) at screening, baseline, and month 3 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
- response to the treatment by the change of Osteocalcin at screening, baseline, and month 3 [ 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, and month 3 [ Time Frame: 3 days, 3 and 6 month (up to 6 month) ]
- response to the treatment by the change of MRI result at screening, baseline, and month 3 [ Time Frame: 3 and 6 month (up to 6 month) ]
Information By: Peking Union Medical College Hospital
Dates:
Date Received: August 28, 2015
Date Started: October 2015
Date Completion:
Last Updated: October 12, 2016
Last Verified: September 2015