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
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
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014