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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00219258
• Collaborator: (none)
• Enrollment: 240
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Treatment of Bone Metastases	Drug: Zoledronic acid	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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
• Study Start Date: Jul 1, 2005

Outcome Measures

Primary Outcome Measures

1. 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

1. Changes in bone markers (urinary N-telopeptide/creatinine ratio, urinary C-telopeptide/creatinine ratio). []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing	Beijing		China

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00219258
• Other Study ID Numbers: CZOL446E2301
• First Posted: Sep 22, 2005
• Last Update Posted: Nov 23, 2009
• Last Verified: Nov 1, 2009

• Additional relevant MeSH terms: Multiple Myeloma; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases; Zoledronic Acid

Study Results

No Results Posted as of Nov 23, 2009