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

Stopped early · Phase 3

Conditions studied: Pain, Bone Neoplasm, Neoplasm Metastasis

In brief

This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00099203

Run by

Hoffmann-La Roche

People needed

163

Starts

2005-07-01

Expected to finish

2007-12-01

Last updated by the study team

2017-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Study site — Brussels, Belgium
• Study site — Turnhout, Belgium
• Study site — Wilrijk, Belgium
• Study site — Greenfield Park, Quebec, Canada
• Study site — Santiago, Chile
• Study site — Lyon, France
• Study site — Nice, France
• Study site — Paris, France
• Study site — Dessau, Germany
• Study site — Duisburg, Germany
• Study site — Heidelberg, Germany
• Study site — Trier, Germany
• Study site — Guatemala City, Guatemala
• Study site — Guatemala City, Guatemala
• Study site — Guatemala City, Guatemala
• Study site — Budapest, Hungary
• Study site — Győr, Hungary
• Study site — Naples, Italy
• Study site — Chihuahua City, Mexico
• Study site — Mexico City, Mexico
• Study site — Mérida, Mexico
• Study site — Panama City, Panama
• Study site — Lodz, Poland
• Study site — Olsztyn, Poland
• Study site — Waratah, Australia

Full record on ClinicalTrials.gov

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