Bone Neoplasm, Neoplasm Metastasis, Pain
Conditions
Brief summary
This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Interventions
6mg iv on days 1-3
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * breast cancer; * bone metastases; * mean worst pain score \>=4 during 3 day baseline period; * stable dose of analgesics over a 3 day baseline period; * adequate renal function.
Exclusion criteria
* bisphosphonate treatment within 3 weeks of study enrollment; * a change in antineoplastic treatment within 6 weeks of study enrollment; * bone radiation within 2 weeks of study enrollment; * active infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption | Days 5 - 7 |
Secondary
| Measure | Time frame |
|---|---|
| Mean worst pain score over first 7 days | Day 7 |
| Analgesic consumption | Day 7 |
| Karnofsky index | Day 7 |
| AEs, laboratory parameters | Throughout study |
Countries
Greece
Outcome results
None listed