Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis

Lung Cancer Clinical Trial

Official title: A Randomized Study to Evaluate the Safety and Efficacy of Loading Dose of Bondronat Versus Standard Dose of Bondronat in Patients With Lung Cancer and Skeletal Metastasis Experiencing Moderate to Severe Pain

Status Terminated

Clinical Trial Summary

The objective of this trial is to assess the efficacy and safety of loading doses versus standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone metastatic disease.

Clinical Trial Description

Patients with lung cancer and bone metastatic disease may experience moderate or severe bone pain. Some researches have reported that loading doses Bondronat (6mg Bondronat on three consecutive days) had great efficacy in reducing pain in patients with malignant bone disease without unacceptable toxicities. So,we designed this clinical trial to compare the efficacy and safety profiles between loading doses Bondronat and standard dose Bondronat.Enrolled patients will receive an intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day. The targeted sample size is 120 individuals. Primary outcome measures will be bone pain response ( ≥ 25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption). Secondary outcome measures will be efficacy including ECOG Performance status, analgesic consumption, bone markers, and safety profiles including AE and laboratory parameters. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

• NCT number: NCT00492843
• Study type: Interventional
• Source: Chinese Society of Lung Cancer
• Status: Terminated
• Phase: Phase 4
• Start date: July 2007
• Completion date: July 2008