Abstract
Background and Aims
Recently, the importance of osteoporosis and chronic kidney disease-mineral bone disorder (CKD-MBD) has been highlighted as a cause of increased fracture risk in dialysis patients. However, many osteoporosis drugs require careful administration or are contraindicated in dialysis patients, and evidence for their use in dialysis patients is scarce. Here, we administered the new human anti-sclerostin antibody preparation romosozumab to hemodialysis patients with osteoporosis, and examined changes in bone density, bone metabolism markers and other values.
Method
Romosozumab was administered once per month to 12 hemodialysis patients (mean age: 72.6 ± 9.4 years old; 4 males, 8 females) who were diagnosed with osteoporosis while visiting our hospital and who had no history of cardiovascular complications in the preceding year. Bone density YAM value was measured every 3 months by dual energy X-ray absorptiometry (DXA). TRACP-5b, BAP, P1NP and whole-PTH values were measured every month as bone metabolic markers. Values at the start of observation were regarded as pre-dosing values and the mean values during the 6 months after administration were measured as post-treatment values. The results were then compared.
Results
At 6 months after the start of treatment, no change was seen in bone density of the proximal femur compared to the pre-dosing value. In contrast, lumbar spine bone density YAM value (%) was significantly improved, from 63.8% ± 9.4% to 70.9% ± 5.2% (P = 0.012). Regarding bone metabolism markers, mean value of bone resorption marker TRACP-5b after the start of administration did not significantly differ from that at the start of observation. BAP value increased significantly from 16.2 ± 8.7 to 25.2 ± 11.0 (p < 0.01) while whole-PTH significantly increased from 103.5 ± 52.8 to 236.1 ± 100.8 (p < 0.01). In addition, serial time changes for each bone metabolic marker, whole-PTH value, and corrected Ca value during the observation period are also reported.
Conclusion
Romosozumab may improve bone density in dialysis patients with osteoporosis.
SP363RELATIONSHIP BETWEEN SERUM SCLEROSTIN, BONE METABOLISM MARKERS, AND FRACTURE IN HEMODIALYSIS PATIENTS: TOKAI DIALYSIS COHORT STUDY