Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee

Novartis

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Osteonecrosis

Interventions

Zoledronic acidDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigative Site

Gordon, Australia

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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