NCT00219258

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

November 23, 2009

Status Verified

November 1, 2009

First QC Date

September 12, 2005

Last Update Submit

November 20, 2009

Conditions

Treatment of Bone Metastases

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

Zoledronic acidDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing

Beijing, China

Location

MeSH Terms

Interventions

Zoledronic Acid

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

July 1, 2005

Last Updated

November 23, 2009

Record last verified: 2009-11

Locations

CN(1)