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

NCT00099177

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Pain, Bone Neoplasm, Neoplasm Metastasis

Interventions: ibandronate [Bondronat], zoledronic acid

Countries: United States, Argentina, Australia, Chile, Germany, Greece, Guatemala, Hungary

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.

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 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 (41)

Miami, Florida, United States
Macon, Georgia, United States
Houston, Texas, United States
Bahía Blanca, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Rosario, Argentina
Santa Fe, Argentina
Adelaide, Australia
Brisbane, Australia
Santiago, Chile
Viña del Mar, Chile
Hamburg, Germany
Kalyftaki Kifissia, Greece
Thessaloniki, Greece
Guatemala City, Guatemala
Budapest, Hungary
Budapest, Hungary
Deszk, Hungary
Szeged, Hungary
Rozzano, Italy
Torino, Italy
La Paz, Mexico
Mexicali, Mexico
Mexico City, Mexico
Monterrey, Mexico
Panama City, Panama
Poznan, Poland
Poznan, Poland
San Juan, Puerto Rico
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