Back to resultsTo Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women
Primary Purpose
Osteopenia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Osteopenia focused on measuring zoledronic acid, bisphosphonate, Low bone mass
Eligibility Criteria
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 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Temperature increase
Secondary Outcome Measures
Questionnaires
VAS (visual analog scale)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00145275
Brief 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
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
Keywords
zoledronic acid, bisphosphonate, Low bone mass
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
455 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Primary Outcome Measure Information:
Title
Temperature increase
Secondary Outcome Measure Information:
Title
Questionnaires
Title
VAS (visual analog scale)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
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
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.
Facility Information:
City
Unavailable
State/Province
Georgia
Country
United States
City
Unavailable
State/Province
Illinois
Country
United States
City
Unavailable
State/Province
Indiana
Country
United States
City
Unavailable
State/Province
Iowa
Country
United States
City
Unavailable
State/Province
Kansas
Country
United States
City
Unavailable
State/Province
Washington
Country
United States
City
Multiple
Country
Australia
City
Multiple
Country
Canada
City
Multiple
Country
Russian Federation
City
Multiple
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
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
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