Status:
TERMINATED
A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Pain
Bone Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- patients with malignant bone disease;
- patients with moderate to severe pain.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00099177
Start Date
August 1 2005
End Date
December 1 2007
Last Update
August 16 2017
Active Locations (41)
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1
Miami, Florida, United States, 33136
2
Macon, Georgia, United States, 31201
3
Houston, Texas, United States, 77030
4
Bahía Blanca, Argentina, B8001HXM