Efficacy and Safety of Zoledronic Acid in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma
This study has been completed.
Information provided by:
First received: September 12, 2005
Last updated: November 20, 2009
Last verified: November 2009
Zoledronic acid is a medication that slows the breakdown of bone. This study will assess the efficacy and safety of zoledronic acid in Chinese patients with multiple myeloma or other solid tumors with bone metastases.
Treatment of Bone Metastases
Drug: Zoledronic acid
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A Randomized, Double-blind, Multi-centre Study to Evaluate the Fficacy and Safety of Zometa as a Treatment in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma
Primary Outcome Measures:
- To compare in a randomized fashion the effect of zoledronate and pamidronate 90 mg on pain relief as assessed by pain score after 1-dose treatment in patients with bone pain induced by any solid tumors with bone metastases or Multiple Myeloma
Secondary Outcome Measures:
- Changes in bone markers (urinary N-telopeptide/creatinine ratio, urinary C-telopeptide/creatinine ratio).
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Cancer patients (multiple myeloma or other solid tumors) and confirmed evidence of bone lesions
- Significant bone pain
- Poor renal function
- Use of other investigational drugs within 30 days of visit 2
- Dental or other surgery to the jaw within 6 weeks of screening, or planned during the 4 week study
Other protocol-defined exclusion criteria may apply.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219258
No publications provided
||External Affairs, Novartis
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2005
||November 20, 2009
||China: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 23, 2014
Neoplasms, Plasma Cell
Bone Marrow Diseases
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Neoplasms by Site
Bone Density Conservation Agents
Physiological Effects of Drugs