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Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00477217
First received: May 22, 2007
Last updated: September 22, 2016
Last verified: September 2016

May 22, 2007
September 22, 2016
January 2008
May 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00477217 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee
A Randomized, Double-blind, Placebo-controlled, Proof of Concept Study of Zoledronic Acid in Spontaneous Osteonecrosis of the Knee (SONK)
This study will assess the safety and efficacy of zoledronic acid in patients presenting with spontaneous osteonecrosis of the knee.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteonecrosis
Drug: Zoledronic acid
Other Name: Reclast, Aclasta
1
Intervention: Drug: Zoledronic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults 40-85 years of age
  • Diagnosis of painful osteonecrosis of the knee within the last month.

Exclusion Criteria:

  • Intravenous (iv) bisphosphonates within the last 2 years.
  • Abnormal thyroid, kidney or liver function.
  • Abnormal blood calcium or alkaline phosphatase levels.

Other protocol-defined inclusion/exclusion criteria may apply

Both
40 Years to 85 Years   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00477217
CZOL446HAU21
Not Provided
Not Provided
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Principal Investigator: Novartis . Novartis Pharmaceuticals
Novartis
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP