NCT00477217

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

May 22, 2007

Last Update Submit

September 22, 2016

Conditions

Osteonecrosis

Keywords

Osteonecrosiszoledronic acidknee

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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.

Study Arms (1)

1

OTHER
Drug: Zoledronic acid

Interventions

Zoledronic acidDRUG
Also known as: Reclast, Aclasta
1

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 40-85 years of age
  • Diagnosis of painful osteonecrosis of the knee within the last month.

You may not qualify if:

  • Intravenous (iv) bisphosphonates within the last 2 years.
  • Abnormal thyroid, kidney or liver function.
  • Abnormal blood calcium or alkaline phosphatase levels.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Gordon, NSW,2072, Australia

Location

MeSH Terms

Conditions

Osteonecrosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis .

    Novartis Pharmaceuticals

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 22, 2007

First Posted

May 23, 2007

Study Start

January 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

AU(1)