drugset / Trial / NCT00352846
Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |