PURPOSE: A few studies have reported the safety of the treatment of elderly osteoporotic patients with chronic kidney disease (CKD) and the possibility of hypocalcemia. The aim of the present study was to examine the relationship between the incidence of hypocalcemia and the CKD stage in elderly osteoporotic patients treated with denosumab. MATERIALS AND METHODS: This study was designed as a parallel-group comparison study between the denosumab-associated hypocalcemia (DAH) groups: the concentration of serum calcium was under 8.6 mg/dl and the normal calcium (NC) groups: the concentration of serum calcium was over 8.6 mg/dl. Fifty-two subjects over 70 years old were enrolled in this study, with 16 patients classified into the DAH group and 36 patients assigned to the NC group. All patients were further classified into two subgroups according to their age, into an around 75 years group to clarify the relevance of old age and an around 85 years group and also into a mild CKD group and a moderate CKD group by based on estimated glomerular filtration (eGFR). Serum calcium concentration, tartrate-resistant acid phosphatase (TRACP-5b), and type 1 procollagen N terminal propeptide (P1NP) were measured, and adverse drug reactions were evaluated. RESULTS: The eGFR and serum calcium were significantly lower in the DAH group than in the NC group in the starting phase. Moreover, TRACP-5b was significantly higher in the DAH group than in the NC group in the starting phase. There were no significant differences in P1NP. The incidence of hypocalcemia was significantly higher in the around 85 groups than in the around 75 groups. The frequency of hypocalcemia was also significantly higher in the severe CKD group than in the mild CKD group. CONCLUSION: Advanced age combined with low eGFR and low serum Ca status appear to be associated with the incidence of hypocalcemia when using denosumab for the treatment of osteoporosis.
PURPOSE: A few studies have reported the safety of the treatment of elderly osteoporotic patients with chronic kidney disease (CKD) and the possibility of hypocalcemia. The aim of the present study was to examine the relationship between the incidence of hypocalcemia and the CKD stage in elderly osteoporotic patients treated with denosumab. MATERIALS AND METHODS: This study was designed as a parallel-group comparison study between the denosumab-associated hypocalcemia (DAH) groups: the concentration of serum calcium was under 8.6 mg/dl and the normal calcium (NC) groups: the concentration of serum calcium was over 8.6 mg/dl. Fifty-two subjects over 70 years old were enrolled in this study, with 16 patients classified into the DAH group and 36 patients assigned to the NC group. All patients were further classified into two subgroups according to their age, into an around 75 years group to clarify the relevance of old age and an around 85 years group and also into a mild CKD group and a moderate CKD group by based on estimated glomerular filtration (eGFR). Serum calcium concentration, tartrate-resistant acid phosphatase (TRACP-5b), and type 1 procollagen N terminal propeptide (P1NP) were measured, and adverse drug reactions were evaluated. RESULTS: The eGFR and serum calcium were significantly lower in the DAH group than in the NC group in the starting phase. Moreover, TRACP-5b was significantly higher in the DAH group than in the NC group in the starting phase. There were no significant differences in P1NP. The incidence of hypocalcemia was significantly higher in the around 85 groups than in the around 75 groups. The frequency of hypocalcemia was also significantly higher in the severe CKD group than in the mild CKD group. CONCLUSION: Advanced age combined with low eGFR and low serum Ca status appear to be associated with the incidence of hypocalcemia when using denosumab for the treatment of osteoporosis.
Authors: D Miyaoka; Y Imanishi; M Ohara; N Hayashi; Y Nagata; S Yamada; K Mori; M Emoto; M Inaba Journal: Osteoporos Int Date: 2018-09-05 Impact factor: 4.507