Trial intelligence / Profile preview

Bondronat vs. zoledronic acid for malignant bone pain

NCT00099203Phase 3

Key facts

Status: Terminated
Start: Jul 2005
Primary completion: Dec 2007
Countries: 18
Sponsor: Roche
Modality: Small Molecules

Drugs: ibandronic acid
Conditions: pain

Overview

Phase 3, randomised, double-blind trial of ibandronic acid in pain (2 arms), sponsored by Roche. Primary endpoint: Pain, as measured by Brief Pain Inventory and analgesic use at 24 weeks. Started Jul 2005; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Arm 1
Bondronat (ibandronate)
Arm 2
Zoledronic acid

Who it enrols

Inclusion of patients with malignant bone disease and moderate to severe pain. Exclusion of patients who have recently received bisphosphonates or investigational therapy, have untreated esophagitis or gastric ulcers, recent or planned bone radiotherapy, or are pregnant or breast-feeding.

Endpoints

Primary

Pain, as measured by Brief Pain Inventory and analgesic use24 weeks

Secondary

Performance score and QoL measures24 weeks
Adverse Events and laboratory parametersThroughout study
Opioid side effectsThroughout study
Skeletal-related eventsThroughout study

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