Background: Zoledronic acid, a third-generation amino bisphosphonate, reduces the incidence of skeletal-related events and pain in patients with bone metastases. The optimal dosing interval for zoledronic acid is uncertain.
Aim: To determine whether the Zoledronic acid 12 weeks regimen was equal to the Zoledronic acid 4 weeks regimen for safety profile with bone metastasis or not.
Patients and Methods: The study is a randomized, clinical trial that was conducted at the Clinical Oncology Department, Zagazig university hospitals in the period from December 2017 to December 2019. Patients with bone metastasis were enrolled in the study. Patients were randomized to receive zoledronic acid every 12 weeks (n = 54) group A vs. every 4 weeks (n = 54) group B for 2 years. Both groups were compared regarding the safety of Zoledronic acid.
Results: The studied groups A and B were matched regarding age and sex distribution. All patients in both groups had pre-treatment normal serum creatinine and serum calcium levels. There was no significant difference between group A and group B regarding post-treatment serum calcium and serum creatinine (p-value=0.243and 0.489) respectively. All patients in both groups did not have osteonecrosis of the jaw.
Conclusion: Zoledronic acid every 12 weeks regimen was equal to zoledronic acid every 4 weeks regimen for safety profile in patients with bone metastasis.
Zoledronic Acid; Safety; Bone Metastasis
Bone is the third most frequent site of metastasis, behind lung and liver. Prostate and breast cancer are responsible for the majority of the skeletal metastases (up to 70%) . Moreover, the bone disease is the most frequent disease-defining clinical feature of multiple myeloma, with 90% of patients developing bone lesions throughout their disease . The overall incidence of bone metastasis is not known . The relative incidence of bone metastasis by type of tumor, in patients with advanced metastatic disease, is 65-75% in BC; 65-75% in the prostate; 60% in the thyroid; 30-40% in the lung; 40% in bladder; 20-25% in renal cell carcinoma and 14-45% in melanoma . The major skeletal complications of bone metastatic disease including cancer-induced bone pain, hypercalcemia, pathological fractures, and spinal cord compression, all of which may profoundly impair a patient’s quality of life . Patients with Metastatic bone disease are generally treated with surgery, radiation therapy, chemotherapy, hormonal therapy according to primary tumor type . Zoledronic acid, a third-generation is given to patients with bone metastasis to decrease skeletal-related events such as bone fractures, spinal cord compression, radiation to bone, or bone surgery and pain. It slows the breakdown of bones, increases bone density, and decreases the amount of calcium being released by the bones into the blood. The optimal dosing interval for the drug has not been established .
It has serious side effects that include kidney problems, low blood calcium, and osteonecrosis of the jaw . So, the present study was conducted to evaluate whether Zoledronic acid every 12 weeks regimen was equal to zoledronic acid every 4 weeks regimen for safety profile with bone metastasis or not as this would result in less toxicity and more economic benefits.