Clin Osteol 2015; 20(3): 123-129

Retrospective study of denosumab treatment in dialysis patientsCase reports

V. Spustová, J. Rosenberger, I. Lajdová, L. Wsolová

Objective: The aim of this retrospective study was to evaluate exp on hemodialysis (CKD 5D) based on available laboratory parameters.

Patients and Methods: The study comprised 33 hemodialysis patients from 18 dialysis centers in Slovakia. Patients received a single dose of denosumab and, on a monthly basis, concentrations of calcium, phosphorus and intact parathyroid hormone (iPTH) were mo­ nitored over a period of six months. The da of p < 0.05 were considered significant.

Results: Serum calcium concentration significantly decreased at one month after denosumab administration, with 15 patients (45 %) having concentrations 1.8 mmol/L. At the same time, there was a significant increase in iPTH concentrations and a decrease in serum phosphorus levels. These changes resulted in treatment modification in each patient. Fifteen patients had baseline iPTH concentra­ tions above 150 pg/mL (suspected mixed or high turnover bone disease; Group I); the other 18 patients had concentrations below 150 pg/mL (suspected adynamic bone disease; Group II). The wing the administration of denosumab varied in the groups.

Conclusion: Treatment with denosumab in patients with CKD 4-5D is currently not evidence-based. Cooperation is necessary between nephrologists and specialists who decide on denosumab treatment. Further research is needed for identification of patients at the hig­ hest risk, finding optimal strategies to minimize serious adverse events and especially histological co

Keywords: chronic kidney disease-mineral and bone disorder (CKD-MBD), denosumab, hypocalcemia, parathy­ roid hormone (PTH), high and low turnover bone disease

Published: December 11, 2015  Show citation

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Spustová V, Rosenberger J, Lajdová I, Wsolová L. Retrospective study of denosumab treatment in dialysis patients. Osteologický bulletin. 2015;20(3):123-129.
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References

  1. Moe S, Drueke T, Cunningham J Goodman W, Martin K, Olgaard K, Ott S, Sprague S, Lameire N, Eknoyan G. Definition, evalution, and classification of renal osteodystrophy: A position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int 2006;69:1945-1953. Go to original source...
  2. Malluche HH, Mawad HW, Monier-Faugere MC. Renal osteodystrophy in the first decade of the new millenium: Analysis of 630 bone biopsies in black and white patients. J Bone Mine Res 2011;26: 1368-1376. Go to original source...
  3. Jamal SA, West SL, Miller PD. Fracture risk assess­ ment in patients with chronic kidney disease. Osteoporos Int 2012;23:1191-1198. Go to original source...
  4. KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int 2009;76(Suppl 113): S1-S130.
  5. Jamal SA, Ljunggren O, Stehman-Breen C, Cummings SR, McClung MR, Goemaere S, Ebeling PR, Franek E, Yang Y, Egbuna OI, Boonen S, Miller PD. Effects of denosumab on fracture and bone mi­ neral density by level ofkidney function. J Bone Min Res 2011;26:1829-1835. Go to original source...
  6. Toussaint ND, Elder GJ, Kerr PG. Bisphosphonates in chronic kidney disease; ba­ lancing potential benefits and adverse effects on bone and soft tissue. Clin J Soc Nephrol 2009;4:221-233. Go to original source...
  7. Block GA, Bone HG, Fang L, Lee E, Padhi D. A single-dose study of denosumab in patients with various degrees of renal impairment. J Bone Min Res 2012;27: 1471-1479. Go to original source...
  8. McCormick BD, Davis J, Burns KD. Severe hypocalcemia following denosumab injection in a hemodialysis patient. Am J Kidney Dis 2012;60:626-628. Go to original source...
  9. Torregrosa JV. Dramatic increase in parathyroid hormone and hypocalcae ter denosumab in a kidney transplanted patient. Clin Kidney J 2013;6:122. Go to original source...
  10. Ivanov P, Khedr M. Prolonged hypocalcaemia following a single dose of 60 mg denosumab in two patients with CKD 4/5 on ci perparathyroidism. Clin Kidney J 2013;6:245. Go to original source...
  11. Ungprasert P, Cheungpasitporn W, Srivali N, Kittanamongkolchai W, Bischof Life-threatening hypocalcemia associated with denosumab in a patient with mo­ derate renal insufficiency. Am J Emergency Med 2013;31:756.e1-756.e2. Go to original source...
  12. Agarwal M, Csongrádi É, Koch CA, Juncos LA, Echols V, Tapolyai M, Fulop T. Severe symptomatic hypocalcemia after denosumab administration in an end-sta­ ge renal disease patient on peritoneal dialysis with controlled secondary hyper rathyroidism. Brit Med J Med Res 2013;3:1398-1406. Go to original source...
  13. Dave V, Chiang CY, Booth J, Mount PF. Hypocalcemia post denosumab in pa­ tients with chronic kidney disease stage 4-5. Am J Nephrol 2015;41:129-137. Go to original source...
  14. Marcelli D, Kirchgessner J, Amato C, Steil H, Mitteregger A, Moscardo V, Carioni C, Orlandini G, Gatti E. EuCliD (European Clinical Database): a databa­ se comparing different realities. J Nephrol 2001;14(Suppl 4):S94-S100.
  15. Stopper A, Amato C, Gioberge S, Giordana G, Marcelli D, Gatti E. Managing complexity at dialysis service centers across Europe. Blood Purif 2007;25(1): 77-89. Go to original source...
  16. Dusilová Sulková S, Horáček J, Šafránek R, Gorun P, Viklický O, Palička V. Denosumab associated with bone density increase and clinical improvement is a long-term hemodialysis patient. Case report and review of the literature. Medica (Hradec Králové) 2014;57:30-34. Go to original source...
  17. Chen CL, Chen NC, Hsu CY, Chou KJ, Lee PT, Fang HC, Renn JH. An open-la­ bel, prospective pilot clinical study of denosumab for severe hyperparathyr in patients with low bone mass undergoing dialysis. J Clin Endocrinol Metab 2014;99:2426-2432. Go to original source...




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