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Abstract: SA-PO182

Therapy With Romosozumab Followed by 1 Year of Denosumab in Hemodialysis Patients With Osteoporosis: An Observational Study

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Saito, Tomohiro, Showa Daigaku, Shinagawa-ku, Tokyo, Japan
  • Mizobuchi, Masahide, Showa Daigaku, Shinagawa-ku, Tokyo, Japan
  • Kato, Tadashi, Showa Daigaku, Shinagawa-ku, Tokyo, Japan
  • Suzuki, Taihei, Showa Daigaku, Shinagawa-ku, Tokyo, Japan
  • Fujiwara, Yasuro, sannoudai hospital, Ibaraki, Japan
  • Kanamori, Naoaki, sannoudai hospital, Ibaraki, Japan
  • Makuuchi, Mikio, sannoudai hospital, Ibaraki, Japan
  • Honda, Hirokazu, Showa Daigaku, Shinagawa-ku, Tokyo, Japan
Background

Evidence of the treatment with romosozumab (ROMO) in hemodialysis (HD) patients is limited. Accordingly, here we report clinical characteristics of ROMO in these patients.

Methods

We conducted a 24-month prospective, observational, single-center cohort study that analyzed 17 HD patients with osteoporosis. These patients received ROMO (210mg) subcutaneously once monthly for 12 months and were then followed by denosumab (60mg) subcutaneously every six months for an additional 12 months. We examined the incidence of new fractures, safety, changes in bone mineral density (BMD), bone metabolism markers, and coronary artery calcification.

Results

There were no cases of new fractures in the study period. The annual percent changes from baseline in the lumbar spine (LS), total hip (TH), and femoral neck (FN) BMD were +9.3%, +3.2%, and +6.9%, respectively. These effects were maintained for 24 months. Relative changes from baseline to 24 months were +14.4%, +5.7%, and +5.6%, respectively. The percent change in TH (r = -0.80; P <0.001) and FN (r= - 0.84; P <0.001) showed negative correlation with the BMD at baseline. Although coronary artery calcification scores slightly increased from 1094.2 at baseline to 1313.1 at 12 months (P = 0.013), fatal events including CVD death and all causes of death were not observed during the ROMO treatment period. Asymptomatic hypocalcemia was observed from 1 to 2 months after the start of ROMO. However, no concomitant drug administration was required, and serum calcium levels returned to approximately baseline levels.

Conclusion

Our study suggests that ROMO followed by denosumab treatment is safe and has effectiveness in increasing LS, TH, and FN BMD. Studies with larger sample sizes are necessary to confirm the clinical utilities of ROMO in HD patients with osteoporosis.