Effects of follow-on therapy after denosumab discontinuation in patients with postmenopausal osteoporosis

Abstract

Objectives

To clarify the effects of follow-on therapy after denosumab (DMAb) discontinuation.

Methods

In this retrospective, multicenter study, postmenopausal patients with osteoporosis who were previously treated by oral bisphosphonates (BP) (n = 26) or teriparatide (TPTD) (n = 27) were switched to DMAb (administered 2.6 times), and then discontinued. Patients (73.1 years, T-scores of the lumbar spine [LS] − 2.7 and femoral neck [FN] − 2.2) were switched to either (1) raloxifene (RAL) (n = 13) or BP [(2) weekly or monthly BP (wmBP) (n = 29) or (3) zoledronate (ZOL) (n = 11)], based on each physician’s decision (mean interval after final DMAb administration was 7.2 months). Bone mineral density (BMD) at final DMAb administration were set as baseline.

Results

Changes in LS BMD at 1.5 years after final DMAb administration were −2.7% in the RAL, 0.7% in the wmBP, and 1.9% in the ZOL (p = .31 between groups), and in FN BMD were −3.8%, −0.8%, and 1.8%, respectively (p = .02 between the RAL and ZOL; p = .048 between the RAL and BP). Clinical vertebral fracture incidence during 1.5 years after final DMAb administration was 23.1% in the RAL, 3.4% in the wmBP, and 0.0% in the ZOL (p = .048 between the RAL and ZOL; p = .015 between the RAL and BP). No significant differences were observed in these parameters between the wmBP and ZOL.

Conclusion

These results may contribute to the selection of adequate follow-on therapy after DMAb discontinuation, although further investigations are required.

Keywords:

• Bisphosphonate
• denosumab
• discontinuation
• follow-on treatment
• postmenopausal osteoporosis

Acknowledgments

The authors thank Keiko Uchishiba for her excellent cooperation in conducting the study.

Conflict of interest

K. Ebina is affiliated with the Department of Musculoskeletal Regenerative Medicine, Osaka University, Graduate School of Medicine, which is supported by Taisho. K. Ebina, M. Hirao, and H. Yoshikawa have received research grants from Asahi-Kasei, Astellas, Chugai, Daiichi Sankyo, Eisai, and Ono. K. Ebina has received payments for lectures from Asahi-Kasei, Astellas, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, and Ono. J. Hashimoto has received research grants from Chugai, Teijin Pharma, and Pfizer, and has received payments for lectures from Chugai. M. Kashii has received payments for lectures from Asahi-Kasei and Astellas. S. Tsuji has received a research grant from Eli Lilly. S. Tsuji has received payments for lectures from Eisai and Eli Lilly. H. Tsuboi has received a research grant from Chugai, and has received payments for lectures from Asahi-Kasei, Astellas, Chugai, Eisai, Eli Lilly, and Pfizer. A. Miyama, H. Nakaya, K. Takahi, G. Okamura, Y. Etani, and K. Takami declare that they have no conflicts of interest. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.