Bone Neoplasm, Neoplasm Metastasis, Pain
Conditions
Brief summary
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.
Interventions
6mg iv on days 1-3, and every 3-4 weeks
DRUGzoledronic acid
4mg iv on day 1 and every 3-4 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain, as measured by Brief Pain Inventory and analgesic use | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Performance score and QoL measures | Week 24 |
| AEs and laboratory parameters | Throughout study |
| Opioid side effects | Throughout study |
| Skeletal-related events | Throughout study |
Countries
Argentina, Australia, Belgium, Canada, Chile, France, Germany, Guatemala, Hungary, Italy, Mexico, Panama, Poland, Puerto Rico, Russia, Switzerland, United Kingdom, United States
Outcome results
None listed