drugset / Trial / NCT00352846

Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss

NCT00352846

Phase 3 Completed 135 enrolled M.D. Anderson Cancer Center Novartis · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: * Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total lumbar spine and femoral neck. Secondary Objectives: * Evaluate the effect of zoledronate on change in BMD at the total hip * Evaluate risk factors for developing osteoporosis on chemotherapy * Determine correlative markers for response to zoledronate 4. Evaluate zoledronate effect on new bone fractures 5. Evaluate the cost-effectiveness of zoledronic acid (with calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).

Timeline

Start
2006-01
Primary completion
2011-09
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Zoledronic acid Other / unclassified 4 mg/m2 Intravenous
Background Calcium carbonate Other / unclassified 1200 mg Oral
Background Vitamin D Other / unclassified 400 mg Oral

Indications