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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00434447




Registration number
NCT00434447
Ethics application status
Date submitted
9/02/2007
Date registered
13/02/2007
Date last updated
27/02/2017

Titles & IDs
Public title
Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases
Scientific title
A Phase IV Study of Zoledronic Acid Therapy in Patients With Bone Metastases From Breast Cancer or Hormone Resistant Prostate Cancer, or Bone Involvement From Multiple Myeloma, Assessing Long-term Efficacy and Safety
Secondary ID [1] 0 0
CZOL446EAU22
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Children's - Other

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

Experimental: Zoledronic Acid - ZOL446


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

Outcomes
Primary outcome [1] 0 0
Safety assessed by incidence of renal impairment, osteonecrosis of the Jaw (ONJ), adverse events and serious adverse events. Efficacy assessed by incidence of skeletal related events (SREs).
Timepoint [1] 0 0
52 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

- Documented bone metastases from breast cancer, prostate cancer or multiple myeloma

- Prior treatment with zoledronic acid for 1-2 yrs

- Life expectancy of at least 6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Prior treatment with bisphosphonates other than zoledronic acid

- Abnormal kidney function

- Current or previous dental problems or planned dental surgery

- Pregnant or likely to become pregnant during the study

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Canberra
Recruitment hospital [2] 0 0
Novartis Investigative Site - Concord
Recruitment hospital [3] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [4] 0 0
Novartis Investigative Site - Wagga Wagga
Recruitment hospital [5] 0 0
Novartis Investigative Site - Redcliffe
Recruitment hospital [6] 0 0
Novartis Investigative Site - Townsville
Recruitment hospital [7] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [8] 0 0
Novartis Investigative Site - Ballarat
Recruitment hospital [9] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [10] 0 0
Novartis Investigative Site - Frankston
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
- Wagga Wagga
Recruitment postcode(s) [5] 0 0
- Redcliffe
Recruitment postcode(s) [6] 0 0
- Townsville
Recruitment postcode(s) [7] 0 0
- Woolloongabba
Recruitment postcode(s) [8] 0 0
- Ballarat
Recruitment postcode(s) [9] 0 0
- Box Hill
Recruitment postcode(s) [10] 0 0
- Frankston

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to monitor the safety and efficacy of long-term treatment with
zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the
jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment
Trial website
https://clinicaltrials.gov/ct2/show/NCT00434447
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmeceuticals
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/NCT00434447