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Clinical Trials/NCT00477217
NCT00477217WithdrawnPhase 2

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

Novartis1 site in 1 countryStarted: January 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Withdrawn
Sponsor
Novartis
Locations
1
Primary Endpoint
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.

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Other

Intervention: Zoledronic acid (Drug)

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.(6 months)
  • Safety as assessed by adverse events.

Investigators

Sponsor
Novartis
Sponsor Class
Industry

Study Sites (1)

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