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Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee

This study has been withdrawn prior to enrollment.
Information provided by:
Novartis Identifier:
First received: May 22, 2007
Last updated: September 22, 2016
Last verified: September 2016
This study will assess the safety and efficacy of zoledronic acid in patients presenting with spontaneous osteonecrosis of the knee.

Condition Intervention Phase
Drug: Zoledronic acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Proof of Concept Study of Zoledronic Acid in Spontaneous Osteonecrosis of the Knee (SONK)

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.

Enrollment: 0
Study Start Date: January 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Zoledronic acid
Other Name: Reclast, Aclasta


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00477217

Novartis Investigative Site
Gordon, Australia, NSW,2072
Sponsors and Collaborators
Principal Investigator: Novartis . Novartis Pharmaceuticals
  More Information

Responsible Party: External Affairs, Novartis Identifier: NCT00477217     History of Changes
Other Study ID Numbers: CZOL446HAU21
Study First Received: May 22, 2007
Last Updated: September 22, 2016

Keywords provided by Novartis:
zoledronic acid

Additional relevant MeSH terms:
Bone Diseases
Musculoskeletal Diseases
Pathologic Processes
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on May 25, 2017