Efficacy and Safety of Zoledronic Acid in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma

Treatment of Bone Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219258
• Other study ID #: CZOL446E2301
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 20, 2009
• Start date: July 2005

Study information

• Verified date: November 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Cancer patients (multiple myeloma or other solid tumors) and confirmed evidence of bone lesions

• Significant bone pain

Exclusion Criteria

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Neoplasms
• Multiple Myeloma
• Neoplasm Metastasis
• Neoplasms, Plasma Cell
• Treatment of Bone Metastases

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
China	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in bone markers (urinary N-telopeptide/creatinine ratio, urinary C-telopeptide/creatinine ratio).