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

NCT00099203

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Pain, Bone Neoplasm, Neoplasm Metastasis

Interventions: ibandronate [Bondronat], zoledronic acid

Countries: United States, Argentina, Australia, Belgium, Canada, Chile, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (72)

Birmingham, Alabama, United States
Sedona, Arizona, United States
Ocoee, Florida, United States
Macon, Georgia, United States
Galesburg, Illinois, United States
Indianapolis, Indiana, United States
Kansas City, Missouri, United States
Henderson, Nevada, United States
Reno, Nevada, United States
Albany, New York, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Arlington, Texas, United States
Beaumont, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Fredericksburg, Texas, United States
Longview, Texas, United States
Round Rock, Texas, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Vancouver, Washington, United States
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
La Plata, Argentina
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