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
Phase 3
Completed
- Conditions
- Osteopenia
- Registration Number
- NCT00145275
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 455
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Temperature increase
- Secondary Outcome Measures
Name Time Method Questionnaires VAS (visual analog scale)