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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This study has been withdrawn prior to enrollment.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
Endpoint Classification: Safety/Efficacy Study
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)
Genders Eligible for Study:   Both

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: Australia: Therapeutic Goods Administration

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 October 25, 2016