Denosumab for dialysis patients with osteoporosis: A cohort study

Abstract

Evidence for the efficacy of denosumab in HD patients is limited. Accordingly, here we report a study on the safety and efficacy of denosumab in these patients. We prospectively followed 324 patients (121 HD and 203 non-HD patients) receiving denosumab between June 2013 and May 2018, assessing changes in bone mineral density (BMD) and bone metabolic markers, and noting side-effects. Annual changes in BMD at the lumbar spine in HD and non-HD patients from baseline were, respectively, 6.7 ± 11.1% and 7.5 ± 10.2% (p = 0.60), those at the femoral neck were 4.3 ± 7.9% and 3.1 ± 9.5% (p = 0.32), and those at the distal radius were −0.5 ± 6.4% and 0.2 ± 13.0% (p = 0.66). The prevalence of hypocalcemia (<8.5 mg/dL) was significantly higher in HD than in non-HD patients (35.6% vs 5.4%, p < 0.001). The median elapsed time between the first injection of denosumab and the occurrence of hypocalcemia was 7 days in HD patients. The decrease of serum calcium was greater in patients with higher TRACP5b, corticosteroid use, and those without CaCO3 supplementation. Our study suggests that denosumab was equally as effective in HD as non-HD patients. However, careful hypocalcemia monitoring, for at least 4 weeks, is recommended for HD patients.

Effects of bone turnover status on the efficacy and safety of denosumab among haemodialysis patients

“…We showed that TRACP-5b, BAP and ALP were associated with a large decline in serum Adj Ca levels. The results were consistent with recent cohort studies of HD patients with osteoporosis treated with denosumab 13 , 14 .…”

“…Recent studies have shown that a higher tartrate-resistant acid phosphatase-5b (TRACP-5b) level, which reflects high bone turnover, is a predictor of hypocalcaemic events 13 , 14 . However, little is known about markers for predicting the effect of denosumab.…”

Differentiating the causes of adynamic bone in advanced chronic kidney disease informs osteoporosis treatment

“…The validity of studies investigating the efficacy of denosumab 79,[118][119][120][121][122][123][124][125][126] and bisphosphonates 79,106,[127][128][129][130] in patients with advanced CKD, including those on dialysis, or in patients with earlier CKD stages presenting with biochemical disturbances of mineral metabolism is limited by small sample sizes.…”

Denosumab for the treatment of HIV-associated osteoporosis with fractures in a premenopausal woman

“…Another important factor to consider is that Dmab is not contraindicated in patients with OP associated with chronic kidney damage (CKD). Dmab, unlike BPs, can be employed also in patients on hemodialysis (17). It is worth mentioning that renal impairment and haemodialysis are associated with an increased risk of hypocalcaemia, especially if proper calcium and vitamin D supplementation is not prescribed, and patients should be monitored closely for the aforementioned side effect.…”