Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00477217

Enrollment

Registered

2007-05-23

Start date

2008-01-31

Completion date

2009-05-31

Last updated

2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteonecrosis

Keywords

Osteonecrosis, zoledronic acid, knee

Brief summary

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

Interventions

DRUGZoledronic acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026