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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 22, 2007

Last Updated Date

November 10, 2008

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00477217 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of Zoledronic Acid in Spontaneous Osteonecrosis of the Knee (SONK)

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Osteonecrosis

Intervention ^ICMJE

Drug: Zoledronic acid

Other Name: Reclast, Aclasta

Study Arm (s)

Intervention: Drug: Zoledronic acid

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2009

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 85 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00477217

Other Study ID Numbers ^ICMJE

CZOL446HAU21

Has Data Monitoring Committee

Not Provided

Responsible Party

External Affairs, Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Novartis .

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

November 2008

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

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