A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

This study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals

Official Title

A Randomized, Placebo-Controlled, Double-Blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain

Conditions

Pain; Bone Neoplasms; Neoplasm Metastasis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Pain, as measured by Brief Pain Inventory and analgesic use

Secondary Outcome Measures:

• Efficacy: Opioid side effects, and Quality of Life measures Safety: Adverse events and laboratory measurements Opioid side effects, skeletal-related events

Study Start

July 2005

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• patients with malignant bone disease
• patients with moderate to severe pain.

Exclusion Criteria:

• patients who have received a bisphosphonate within 3 weeks from the signing of the informed consent
• patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing
• untreated esophagitis or gastric ulcers
• recent or pre-scheduled radiotherapy to bone
• patients who are pregnant or breast-feeding.

Total Enrolment

Contact Details

• ST. LEONARDS, 2065, Australia
• WARATAH, 2298, Australia

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