Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee

This study has been terminated.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00477217
First received: May 22, 2007
Last updated: November 10, 2008
Last verified: November 2008
  Purpose

This study will assess the safety and efficacy of zoledronic acid in patients presenting with spontaneous osteonecrosis of the knee.


Condition Intervention Phase
Osteonecrosis
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.

Estimated Enrollment: 20
Study Start Date: January 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Zoledronic acid
Other Name: Reclast, Aclasta

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Criteria

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 ClinicalTrials.gov identifier: NCT00477217

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

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00477217     History of Changes
Other Study ID Numbers: CZOL446HAU21
Study First Received: May 22, 2007
Last Updated: November 10, 2008
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by Novartis:
Osteonecrosis
zoledronic acid
knee

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014