A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

Stopped early · Phase 3

Conditions studied: Pain, Bone Neoplasm, Neoplasm Metastasis

In brief

This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral 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 followed by Bondronat 5Omg po daily from day 22 to week 24) 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

NCT00099177

Run by

Hoffmann-La Roche

People needed

96

Starts

2005-08-01

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 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 — Miami, Florida, United States
• Study site — Macon, Georgia, United States
• Study site — Houston, Texas, United States
• Study site — Bahía Blanca, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Rosario, Argentina
• Study site — Santa Fe, Argentina
• Study site — Adelaide, Australia
• Study site — Brisbane, Australia
• Study site — Santiago, Chile
• Study site — Viña del Mar, Chile
• Study site — Hamburg, Germany
• Study site — Kalyftaki Kifissia, Greece
• Study site — Thessaloniki, Greece
• Study site — Guatemala City, Guatemala
• Study site — Budapest, Hungary
• Study site — Budapest, Hungary
• Study site — Deszk, Hungary
• Study site — Szeged, Hungary
• Study site — Rozzano, Italy
• Study site — Torino, Italy
• Study site — La Paz, Mexico
• Study site — Mexicali, Mexico
• Study site — Mexico City, Mexico

Full record on ClinicalTrials.gov

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