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NCT00477217 Clinical Trial

Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee

Osteonecrosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00477217
Other study ID # CZOL446HAU21
Secondary ID
Status Withdrawn
Phase Phase 2
First received May 22, 2007
Last updated September 22, 2016
Start date January 2008
Est. completion date May 2009

Study information
Verified date September 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Australia: Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers
Gender Both
Age group 40 Years to 85 Years
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• Zoledronic acid

Locations
Country Name City State
Australia Novartis Investigative Site Gordon

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Safety as assessed by adverse events.
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