Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00477217




Registration number
NCT00477217
Ethics application status
Date submitted
22/05/2007
Date registered
23/05/2007
Date last updated
23/09/2016

Titles & IDs
Public title
Zoledronic Acid Treatment of Spontaneous Osteonecrosis of the Knee
Scientific title
A Randomized, Double-blind, Placebo-controlled, Proof of Concept Study of Zoledronic Acid in Spontaneous Osteonecrosis of the Knee (SONK)
Secondary ID [1] 0 0
CZOL446HAU21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteonecrosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zoledronic acid

Other: 1 -


Treatment: Drugs: Zoledronic acid
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Safety as assessed by adverse events.
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- Adults 40-85 years of age

- Diagnosis of painful osteonecrosis of the knee within the last month.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Gordon
Recruitment postcode(s) [1] 0 0
NSW,2072 - Gordon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the safety and efficacy of zoledronic acid in patients presenting with
spontaneous osteonecrosis of the knee.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00477217
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis .
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00477217