Status:
COMPLETED
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
Lead Sponsor:
Novartis
Conditions:
Osteopenia
Eligibility:
FEMALE
45-75 years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- Women greater than or equal to 45 years and less than or equal to 75 years of age inclusive
- Low bone mineral density
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
455 Patients enrolled
Trial Details
Trial ID
NCT00145275
Start Date
December 1 2004
End Date
October 1 2005
Last Update
April 27 2012
Active Locations (10)
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1
Unavailable, Georgia, United States
2
Unavailable, Illinois, United States
3
Unavailable, Indiana, United States
4
Unavailable, Iowa, United States