From the FDA Drug Label
Limitations of Use: The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia. Limitations of Use The safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non–tumor-related conditions have not been established.
Aclasta (zoledronic acid) is not indicated for the treatment of hyperparathyroidism. The safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism have not been established 1, 1, 1.
From the Research
Aclasta (zoledronic acid) can be used in patients with primary hyperparathyroidism, particularly when surgery is not an option or to manage bone-related complications, with the standard dose being 5 mg given as an intravenous infusion once yearly, as supported by the most recent and highest quality study available 2. The use of Aclasta in patients with primary hyperparathyroidism is based on its efficacy in increasing bone mineral density and reducing fracture risk, as demonstrated in studies on osteoporosis treatment 2, 3. Before administering Aclasta, it is essential to ensure the patient is adequately hydrated and has sufficient vitamin D levels (above 30 ng/mL) and normal calcium levels to prevent hypocalcemia, as hypocalcemia is a potential side effect of zoledronic acid therapy. Some key points to consider when using Aclasta in patients with primary hyperparathyroidism include:
- Monitoring renal function, as Aclasta is contraindicated in patients with creatinine clearance below 35 mL/min 2
- Managing common side effects, such as flu-like symptoms within the first three days after infusion, with acetaminophen
- Recognizing that Aclasta does not address the underlying cause of primary hyperparathyroidism or normalize calcium levels, and that parathyroidectomy remains the primary treatment for symptomatic primary hyperparathyroidism, with Aclasta serving as an adjunctive therapy for bone protection when surgery is delayed or contraindicated. It is also important to note that secondary hyperparathyroidism, which can occur in patients with chronic kidney disease, is a complex pathology that requires careful management to prevent bone disease and vascular calcification 4. Additionally, elevated parathyroid hormone levels have been associated with an increased risk of cardiovascular disease, highlighting the importance of managing primary hyperparathyroidism to reduce this risk 5.