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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/NCT00145275




Registration number
NCT00145275
Ethics application status
Date submitted
1/09/2005
Date registered
5/09/2005
Date last updated
27/04/2012

Titles & IDs
Public title
To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women
Scientific title
To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women
Secondary ID [1] 0 0
CZOL446H2407
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteopenia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

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

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

Outcomes
Primary outcome [1] 0 0
Temperature increase
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Questionnaires
Timepoint [1] 0 0
Secondary outcome [2] 0 0
VAS (visual analog scale)
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- Women greater than or equal to 45 years and less than or equal to 75 years of age
inclusive

- Low bone mineral density
Minimum age
45 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
Key exclusion criteria
- Certain prior treatments for low bone mass/osteopenia

- Current use of medicines (prescription or non-prescription) for pain, fever, or
inflammation

- Impaired kidney function

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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Multiple
Recruitment postcode(s) [1] 0 0
- Multiple
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Canada
State/province [7] 0 0
Multiple
Country [8] 0 0
Russian Federation
State/province [8] 0 0
Multiple
Country [9] 0 0
South Africa
State/province [9] 0 0
Multiple

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

Ethics approval
Ethics application status

Summary
Brief summary
Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such
as headache, fever, muscle aches, and pains, may occur following the infusion. This study
will investigate the use of over-the-counter medicines to improve these symptoms.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00145275
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT00145275