drugset / Trial / NCT00346242

Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events

NCT00346242

Phase 4 Completed 60 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupSingle-blindPrevention

Summary

The evaluation of efficacy is performed by laboratory monitoring of bone density and resorption markers and clinical monitoring of bone density improvement. This is a prospective, randomized, parallel group, single blind study of one year treatment with zoledronic acid every 6 months as compared to one year treatment with zoledronic acid every 3 months and to placebo every 3 months in patients with hemoglobin syndromes and risk of skeletal complications.

Timeline

Start
2004-03
Primary completion
2006-03
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Zoledronic acid Other / unclassified

Indications