Clinical Trial: Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Randomized, Double-blind, Placebo-controlled, Proof of Concept Study of Zoledronic Acid in Spontaneous Osteonecrosis of the Knee (SONK)
Brief Summary: This study will assess the safety and efficacy of zoledronic acid in patients presenting with spontaneous osteonecrosis of the knee.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Changes from baseline after 3 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI. [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Changes from baseline after 6 months in a) knee pain scores (using the KOOS pain subscale), and b) volume of osteonecrotic lesion (indicated by bone marrow oedema) on MRI. [ Time Frame: 6 months ]
- Safety as assessed by adverse events.
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: May 22, 2007
Date Started: January 2008
Date Completion:
Last Updated: September 22, 2016
Last Verified: September 2016
