Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee

Phase 2

Withdrawn

• Conditions: Osteonecrosis
• Interventions: Drug: Zoledronic acid

• Registration Number: NCT00477217
• Lead Sponsor: Novartis

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 available

Study Timeline

• Study First Submitted: 2007-05-22
• Study First Submitted QC: 2007-05-22
• Study First Posted: 2007-05-23
• Study Start: 2008-01
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Zoledronic acid	-

Primary Outcome Measures

Name	Time	Method
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.	3 months

Secondary Outcome Measures

Name	Time	Method
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.	6 months
Safety as assessed by adverse events.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇦🇺 Gordon, Australia