drugset / Trial / NCT00489424

Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass

NCT00489424

Phase 4 Completed 793 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post menopausal women with low bone mass.

Timeline

Start
2007-06
Primary completion
2007-12
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 325 mg
Subject Fluvastatin Other / unclassified 40 mg

Indications