Category: Federal Forum Posters
Purpose: The purpose of this study is to determine if initiating bone-targeted therapy with zoledronic acid with a longer interval (every 3 months) is safe and effective in a Veteran population. The primary objective of this trial is incidence of skeletal related events (SREs) in a Veteran population receiving 1 month vs 3 month dosing of zoledronic acid within 2 years of therapy initiation compared to a randomized clinical trial results.
Methods: This is a retrospective, non-inferiority trial that will include patients who have received intravenous zoledronic acid for the prevention or treatment of skeletal complications associated with bone metastases. The study will be sent to the Institutional Review Board for approval. Electronic medical records will be reviewed to determine the incidence and timeline of skeletal related events. The following data will be collected: age, gender, cancer diagnosis, prior bisphosphonate use, documented bone lesion, zoledronic acid dose, zoledronic acid dosing interval, number of zoledronic acid doses, type of SRE, history of SRE, time to first SRE, time to second SRE, SRE while on treatment, baseline creatinine, renal dose adjustments, hypocalcemia while on treatment, incidence of osteonecrosis of the jaw, and calcium/vitamin D supplementation prescriptions. Confidentially will be maintained with data collected. The primary outcome of this study will be the incidence rates of SREs in this trial compared to incidence of SREs in a published clinical study with 1 month vs 3 month dosing of zoledronic acid. Additionally, safety data will be assessed including incidence of renal toxicity, hypocalcemia, and osteonecrosis of the jaw with use of zoledronic acid.
Results: not applicable
Conclusion: not applicable
Andrea Bailey– PGY1 Pharmacy Resident, Southern Arizona VA Healthcare System, Tucson, AZ