Back to resultsZoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee
Primary Purpose
Osteonecrosis
Status
Withdrawn
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Osteonecrosis focused on measuring Osteonecrosis, zoledronic acid, knee
Eligibility 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
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
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.
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.
Safety as assessed by adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00477217
Brief Title
Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee
Official Title
A Randomized, Double-blind, Placebo-controlled, Proof of Concept Study of Zoledronic Acid in Spontaneous Osteonecrosis of the Knee (SONK)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will assess the safety and efficacy of zoledronic acid in patients presenting with spontaneous osteonecrosis of the knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteonecrosis
Keywords
Osteonecrosis, zoledronic acid, knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Reclast, Aclasta
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Safety as assessed by adverse events.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis .
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Gordon
ZIP/Postal Code
NSW,2072
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee
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