Bisphosphonates, such as pamidronate and more recently zoledronate, are commonly used for palliation of pain related to malignant osteolysis. Acute systemic inflammatory responses, cardiac arrhythmias, ocular toxicity and significant elevations in pro-inflammatory cytokines have been observed in association with bisphosphonate therapy in humans, although the frequency is uncertain. The primary objective of this study is to investigate if there is an increase in biomarkers of inflammation and myocardial injury after zoledronate administration in dogs with malignant osteolysis. A secondary objective is to assess body temperature and to determine if there is an association between zoledronic acid-induced rise in temperature and elevation in inflammatory biomarkers.
All dogs must be at least one year old on Day 0.
All dogs must weigh at least 5kg on Day 0.
All dogs must have complete baseline cancer staging involving physical exam, chemistry profile and urinalysis prior to enrollment.
Dogs must have adequate organ function as indicated by standard laboratory tests: hematology (CBC), clinical chemistry and urinalysis.
All dogs must have either radiographic or advanced imaging to confirm the presence of a lytic bone lesion.
All dogs must be intended to receive intravenous zoledronate to alleviate associated bone pain as part of their therapeutic plan.
Dogs that had received prior bisphosphonate (pamidronate or zoledronate) administration.
Evidence of severe kidney dysfunction.
Dogs that are receiving corticosteroids for at least 7 days prior to enrollment.
The study will cover the costs associated with one administration of one dose of zoledronate, three CBCs, and the costs of blood tests involved in the study. This amounts to a total financial benefit of approximately $550. The client will be responsible for all other costs associated with the cancer staging (initial consult, chemistry profile, urinalysis, and radiographic or other advanced imaging evidence of a lytic bone lesion) as well as any additional treatments with zoledronate or other cancer therapy during and after completion of the study. Each patient’s participation will allow us to gain information which will help in the side effect management of future dogs undergoing treatment with zoledronate.
If you believe you have a patient who is eligible for this clinical trial study or you would like additional information from the Clinical Trials Office at the Cummings Veterinary Medical Center, complete a referring physician questionnaire.