Multiple Adverse Effects of Denosumab: Management Implications in the Elderly Patients

Presentation Number: SUN 327
Date of Presentation: April 2nd, 2017

Satbir Kaur Singh*1, Kaitlin Ditch1, Deepika Santosh Reddy1 and Vishnu Sundaresh2
1University of Utah, Salt Lake City, UT, 2University Of Utah, Salt Lake City, UT


BACKGROUND: Osteoporosis management is challenging as patients are choosing to forego therapy due to potential adverse effects. We present an elderly postmenopausal female with severe osteoporosis and renal insufficiency who developed symptomatic hypocalcemia, severe musculoskeletal pain, and persistent tongue numbness after one dose of Denosumab.

CLINICAL CASE: A 75-year-old postmenopausal white female with history of Diabetes Mellitus Type 2 and CKD Stage 3 presented with gross hematuria. She had acute kidney injury secondary to pauci-immune vasculitis and was treated with corticosteroids. She received a course of cyclophosphamide and rituximab with no adverse effects. She also required treatment with short-term hemodialysis and plasmapheresis. Prednisone 60 mg alone was continued. Sixty days later she sustained a non-traumatic right hip fracture. Pertinent medications included prednisone, warfarin, esomeprazole, bumetanide, oxycodone, cyanocobalamin, calcium carbonate and ergocalciferol. Family history was significant for osteoporosis related hip fracture in her mother and osteoporosis in her sister. Laboratory revealed serum calcium of 8.7 (8.4-10.5 mg/dL), albumin 3.7 (3.5-5.0 g/dL), BUN 57 (8-24 mg/dL), eGFR 18 mL/min/1.73 BSA, serum creatinine 2.5 (0.57-1.11 mg/dL), 25 hydroxyvitamin-D3 17 (30-80 ng/mL), PTH 176 (15-65 pg/mL), and vitamin B12 134 (180-915 pg/mL). DXA BMD was consistent with osteoporosis. She was treated with Denosumab 60 mcg subcutaneously. Within four days, she reported tingling and numbness of the lips, tongue and fingers. She also complained of severe generalized muscle and joint pain. Nadir calcium was 7.0 mg/dL, albumin 3.5 g/dL, BUN 56 mg/dL, serum creatinine 3.0 mg/dL, and eGFR 15. She was treated with calcium carbonate 2000 mg PO QID, calcitriol 0.25 mcg PO daily, and ergocalciferol 50,000 IU weekly with normalization of serum calcium levels. Four months later, musculoskeletal symptoms persisted but improved, and tongue numbness persisted despite the normalization of vitamin B12 to 243 pg/mL.

CONCLUSION: Denosumab, an anti-resorptive agent, has unique advantages in the setting of renal insufficiency. Apart from the known adverse effects, we report persistent numbness of the tongue as a suspected adverse effect of Denosumab. Continued research is required to identify predictors of adverse effects in the elderly and guidelines should emphasize preventive measures. Shared decision making tools must be developed to facilitate patient-physician discussion to improve patient knowledge, medication adherence and clinical outcomes.


Nothing to Disclose: SKS, KD, DSR, VS