Safety and Efficacy of Denosumab in Osteoporotic Hemodialysed Patients

Overview

Journal J Nephrol

Publisher Springer

Specialty Nephrology

Date 2016 Jul 11

PMID 27394428

Citations 24

Authors

Francescaromana Festuccia

Maryam Tayefeh Jafari

Alessandra Moioli

Claudia Fofi

Simona Barberi

Stefano Amendola

Salvatore Sciacchitano

Giorgio Punzo

Paolo Mene

Affiliations

Soon will be listed here.

Abstract

Background And Aims: In elderly subjects, renal insufficiency and osteoporosis often coexist with high risk of fracture and elevated socio-economic burden. Today a large number of effective anti-osteoporotic drugs are available but generally they are contraindicated in patients with chronic kidney disease (CKD) because of their progressive accumulation. Denosumab, instead, does not require dose adjustments for different degrees of renal impairment so it can be a valid treatment in osteoporotic patients with CKD. Limited data are available in the literature concerning the use of denosumab in hemodialysis (HD). The aim of our study was, therefore, to study the efficacy and tolerability of this drug in this particular subset of patients.

Methods: We retrospectively reviewed the charts of 12 osteoporotic HD patients who received a single 60-mg subcutaneous dose of denosumab every 6 months for an observation period of 24 months. Serum electrolyte, markers of bone turnover and quantitative ultrasound (QUS) were evaluated.

Results: Over 24 months, we observed a gradual improvement of bone metabolism: β-CrossLaps from 2567.08 ± 1264 to 1492.5 ± 1182.5 pg/ml; bone alkaline phosphatase (BALP) from 33.5 ± 28.8 to 11.8 ± 3.7 mcg/l, and of QUS index (T-score from -5.33 ± 1.58 to -4.84 ± 1.2; risk of fracture from 13.9 ± 4.7 to 11.07 ± 5.3 %). Few cases of hypocalcemia were detected, more significant after the first and second injection, but with careful monitoring of serum calcium and rapid therapy adjustment we could easily manage serum Ca levels.

Conclusions: Our pilot experience highlights the safety and efficacy of denosumab in the treatment of osteoporosis in HD patients, potentially supporting its use to reduce the burden of fractures in this patient population.

Citing Articles

Long-Term Efficacy and Safety of Denosumab: Insights beyond 10 Years of Use.

Ha J, Lee Y, Kim J, Jeong C, Lim Y, Lee J Endocrinol Metab (Seoul). 2025; 40(1):47-56.

PMID: 39801038 PMC: 11898325. DOI: 10.3803/EnM.2024.2125.

Effect of denosumab on the incidence of fractures and mortality in patients undergoing hemodialysis: A retrospective cohort study.

Kobayashi A, Yaginuma T, Kato K, Nakashima A, Ohkido I, Yokoo T PLoS One. 2024; 19(8):e0309657.

PMID: 39208258 PMC: 11361560. DOI: 10.1371/journal.pone.0309657.

Is denosumab an efficient and safe drug for osteoporosis in dialysis patients? Considerations and state of the art about its use in this setting.

Simonini M, Bologna A, Vezzoli G Int Urol Nephrol. 2024; 56(10):3285-3293.

PMID: 38856936 DOI: 10.1007/s11255-024-04110-9.

Effect of Denosumab on Bone Health, Vascular Calcification, and Health-Related Quality of Life in Hemodialysis Patients with Osteoporosis: A Prospective Observational Study.

Kim H, Lee E, Woo S, Rho S, Jung J J Clin Med. 2024; 13(5).

PMID: 38592300 PMC: 10934499. DOI: 10.3390/jcm13051462.

Long-term effects of denosumab on bone mineral density and turnover markers in patients undergoing hemodialysis.

Kato K, Yaginuma T, Kobayashi A, Nakashima A, Ohkido I, Yokoo T J Bone Miner Metab. 2024; 42(2):264-270.

PMID: 38512458 PMC: 10982096. DOI: 10.1007/s00774-024-01505-7.

References

Jamal S, West S, Miller P . Fracture risk assessment in patients with chronic kidney disease. Osteoporos Int. 2011; 23(4):1191-8. DOI: 10.1007/s00198-011-1781-0. View

Fernandez-Martin J, Carrero J, Benedik M, Bos W, Covic A, Ferreira A . COSMOS: the dialysis scenario of CKD-MBD in Europe. Nephrol Dial Transplant. 2012; 28(7):1922-35. DOI: 10.1093/ndt/gfs418. View

Babayev R, Nickolas T . Can one evaluate bone disease in chronic kidney disease without a biopsy?. Curr Opin Nephrol Hypertens. 2014; 23(4):431-7. PMC: 4144009. DOI: 10.1097/01.mnh.0000447014.36475.58. View

Kazama J, Matsuo K, Iwasaki Y, Fukagawa M . Chronic kidney disease and bone metabolism. J Bone Miner Metab. 2015; 33(3):245-52. DOI: 10.1007/s00774-014-0639-x. View

Tentori F, McCullough K, Kilpatrick R, Bradbury B, Robinson B, Kerr P . High rates of death and hospitalization follow bone fracture among hemodialysis patients. Kidney Int. 2013; 85(1):166-73. PMC: 3910091. DOI: 10.1038/ki.2013.279. View

Dusilova Sulkova S, Horacek J, Safranek R, Gorun P, Viklicky O, Palicka V . Denosumab associated with bone density increase and clinical improvement in a long-term hemodialysis patient. Case report and review of the literature. Acta Medica (Hradec Kralove). 2014; 57(1):30-3. DOI: 10.14712/18059694.2014.6. View

Olszynski W, Adachi J, Hanley D, Davison K, Brown J . Comparison of Speed of Sound Measures Assessed by Multisite Quantitative Ultrasound to Bone Mineral Density Measures Assessed by Dual-Energy X-Ray Absorptiometry in a Large Canadian Cohort: the Canadian Multicentre Osteoporosis Study (CaMos). J Clin Densitom. 2015; 19(2):234-41. DOI: 10.1016/j.jocd.2015.04.004. View

Min Y . Update on denosumab treatment in postmenopausal women with osteoporosis. Endocrinol Metab (Seoul). 2015; 30(1):19-26. PMC: 4384669. DOI: 10.3803/EnM.2015.30.1.19. View

Brown J, Prince R, Deal C, Recker R, Kiel D, de Gregorio L . Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial. J Bone Miner Res. 2008; 24(1):153-61. DOI: 10.1359/jbmr.0809010. View

10.

Goldfarb M, Gondek S, Lim S, Farra J, Nose V, Lew J . Postoperative hungry bone syndrome in patients with secondary hyperparathyroidism of renal origin. World J Surg. 2012; 36(6):1314-9. DOI: 10.1007/s00268-012-1560-x. View

11.

Yano S, Suzuki K, Sumi M, Tokumoto A, Shigeno K, Himeno Y . Bone metabolism after cinacalcet administration in patients with secondary hyperparathyroidism. J Bone Miner Metab. 2009; 28(1):49-54. DOI: 10.1007/s00774-009-0102-6. View

12.

Altun E, Paydas S, Kaya B, Balal M . Prolonged hypophosphatemia following parathyroidectomy in chronic hemodialysis patients. Saudi J Kidney Dis Transpl. 2015; 26(5):976-9. DOI: 10.4103/1319-2442.164582. View

13.

. Osteoporosis prevention, diagnosis, and therapy. NIH Consens Statement. 2001; 17(1):1-45. View

14.

Bandeira F, Costa A, Soares Filho M, Pimentel L, Lima L, Bilezikian J . Bone markers and osteoporosis therapy. Arq Bras Endocrinol Metabol. 2014; 58(5):504-13. DOI: 10.1590/0004-2730000003384. View

15.

Dempster D, Lambing C, Kostenuik P, Grauer A . Role of RANK ligand and denosumab, a targeted RANK ligand inhibitor, in bone health and osteoporosis: a review of preclinical and clinical data. Clin Ther. 2012; 34(3):521-36. DOI: 10.1016/j.clinthera.2012.02.002. View

16.

Kazama J, Iwasaki Y, Fukagawa M . Uremic osteoporosis. Kidney Int Suppl (2011). 2014; 3(5):446-450. PMC: 4089591. DOI: 10.1038/kisup.2013.93. View

17.

Nickolas T, Leonard M, Shane E . Chronic kidney disease and bone fracture: a growing concern. Kidney Int. 2008; 74(6):721-31. PMC: 4139042. DOI: 10.1038/ki.2008.264. View

18.

Moe S, Drueke T, Cunningham J, Goodman W, Martin K, Olgaard K . Definition, evaluation, and classification of renal osteodystrophy: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2006; 69(11):1945-53. DOI: 10.1038/sj.ki.5000414. View

19.

Delanaye P, Souberbielle J, Lafage-Proust M, Jean G, Cavalier E . Can we use circulating biomarkers to monitor bone turnover in CKD haemodialysis patients? Hypotheses and facts. Nephrol Dial Transplant. 2013; 29(5):997-1004. DOI: 10.1093/ndt/gft275. View

20.

Eastell R, Christiansen C, Grauer A, Kutilek S, Libanati C, McClung M . Effects of denosumab on bone turnover markers in postmenopausal osteoporosis. J Bone Miner Res. 2010; 26(3):530-7. DOI: 10.1002/jbmr.251. View