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

Phase 3CompletedNCT00219258

Novartis240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Treatment of Bone Metastases

Interventions

Zoledronic acidDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing

Beijing, China

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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