Abstract: FR-PO045

Denosumab: Is It Safe to Use in CKD?

Session Information

Category: Nephrology Education

  • 1302 Fellows and Residents Case Reports

Authors

  • Mckenna, Eimear, Altnagelvin Area Hospital, Coleraine, United Kingdom
  • Shivashankar, Girish H, Western Health and social care Trust, Londonderry, United Kingdom
  • Mccarroll, Francis, Western Health and Social Care Trust, Derry, United Kingdom
Background

Denosumab is a monoclonal antibody directed against receptor activator of RANK ligand used to treat osteoporosis. It has been promoted as safe to use in Chronic Kidney Disease (CKD) as it does not appear to accumulate in kidney failure and because of the experience in a small number of patients with CKD stages 3 and 4 in RCTs. There is no evidence for use in CKD stage 5. Published case reports suggest patients with severe CKD are at higher risk of developing hypocalcemia following Denosumab which may be due to hyperparathyroidism and vitamin D deficiency. In this case series we have examined the incidence of hypocalcemia following Denosumab to identify risk factors for hypocalcemia.

Methods

Retrospective data was collected using an electronic patient database on patients with CKD stages 3-5 attending our service who received Denosumab in the last 5 years. We examined Corrected calcium levels prior to and after each dose, Vitamin D and Parathormone (PTH) levels prior to each dose.

Results

14 patients were identified; 9 had a functioning renal transplant and 1 patient was on hemodialysis. 4 patients were male and 10 female. Mean duration of treatment was 2.2 years. Average eGFR was 27 ml/min/1.73m2. Mean patient age was 60 years. Mean BMI was 25. 11 patients were on oral steroids. The average calcium prior to dosing was 2.35 mmol/l, falling to 1.98mmol/l after dosing. 9 patients achieved their lowest calcium at 1 week, 2 at 4 weeks and 3 at 8 weeks. Average PTH level prior to dosing was 153ng/l and after was 888ng/l. 5 patients developed severe hypocalcemia (corrected calcium less than1.9mmol/l), the average prior calcium in this group was 2.39mmol/l, falling to 1.77mmol/l. The average prior PTH was 206ng/l, rising to 1171ng/l. Four patients did not have Vitamin D status checked before dosing.

Conclusion

Denosumab will cause a small but not clinically significant reduction in serum Calcium in most patients with CKD. Severe hypocalcaemia can result if Vitamin D levels are unknown or in higher PTH levels. eGFR does not seem to correlate with the risk of hypocalcaemia. Biochemical abnormalities associated with CKD should be corrected, specifically, calcium, phosphate, PTH and vitamin D. Densoumab is the preferred treatment in CKD 4/5 however its use should be avoided in severe hyperparathyroidism and vitamin D deficiency.