Safety of Denosumab in CKD 5 patients

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SUN 234-256-Bone & Calcium Metabolism: Clinical Trials & Case Series
Clinical
Sunday, June 16, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SUN-254
Fatima Al kaabi*1, Qutaiba Hussain2, Bachar Afandi2 and Bassam Bernieh2
1AL Ain Hospital, Al Ain, United Arab Emirates, 2Tawam Hospital, Al Ain, United Arab Emirates
Safety of Denosumab in CKD 5 patients

Fatima Al Kaabi1 ,  Qutaiba Hussain 2 , Bachar Afandi1 , and Bassam Bernieh2

Endocrinology1 and Nephrology2  Divisions, Department of Medicine, Tawam Hospital, Al Ain, UAE

Background:

Denosumab is a fully human monoclonal antibody that targets RANKL (receptor activator for nuclear factor κB ligand). By blocking the binding of RANKL to RANK, denosumab decreases the number and activity of osteoclasts, decreases bone resorption, and increases bone mineral density (BMD). Denosumab is currently approved for use in postmenopausal osteoporotic women. Its safety in CKD stage 1-4 was demonstrated in a large prospective study. We herein report a case of stage 5 CKD, osteoporotic patient, who received Denosumab and developed significant hypocalcemia.

Cases:

This is a 70 year old lady with history of T2 DM, HTN, and stage 5 chronic kidney disease (CKD 5) (S.Cr.427 µmol/l). Her DEXA scan revealed osteoporosis in the lumbar spine and right femur. Her corrected calcium before the injection was 2.38mmol/l, and her S. Cr. 427 µmol/l. she was maintained on calcium and vitamin D supplements.

Patient was treated with 60 mg Denosumab as SC injection and was instructed to continue all her medications. Three weeks after the injection, she presented to the emergency room with severe weakness, numbness, anorexia, nausea and vomiting which started 3 days after the injection, and led her to stop all her medications. Her evaluation revealed ill looking, and dehydrated, old lady. Her corrected ca was 1.3mmol/l, and S. Cr.432 µmol/l.Patient was managed by IV fluids and calcium then switched to oral ca and active vitamin D. she improved dramatically and was discharged home with corrected calcium of 2.22 mmol/L, and S. Cr.349 µmol/l

Conclusions: 

Denosumab might induce significant hypocalcemia in CKD 5 patients. Therefore, it should be used very carefully, if ever, in this group of patients with close monitoring of calcium level on weekly basis. Patients’ instructions should include appropriate dosing of calcium and vitamin D supplements. Finally, Denosumab had no adverse effect on kidney function in our CKD5 patient.

Nothing to Disclose: FA, QH, BA, BB

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm