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NCT00145275 Clinical 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

Osteopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00145275
Other study ID # CZOL446H2407
Secondary ID
Status Completed
Phase Phase 3
First received September 1, 2005
Last updated April 26, 2012
Start date December 2004
Est. completion date October 2005

Study information
Verified date April 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 455
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers
Gender Female
Age group 45 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• zoledronic acid

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Russian Federation,  South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary Temperature increase
Secondary Questionnaires
Secondary VAS (visual analog scale)
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