Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee

September 22, 2016 updated by: Novartis

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Gordon, Australia, NSW,2072
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Drug: Zoledronic acid
Other Names:
  • Reclast, Aclasta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months
Safety as assessed by adverse events.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Principal Investigator: Novartis ., Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

May 22, 2007

First Submitted That Met QC Criteria

May 22, 2007

First Posted (Estimate)

May 23, 2007

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446HAU21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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