Endocrinol Metab.  2021 Feb;36(1):60-69. 10.3803/EnM.2020.848.

Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study

• Baek KH
• Chung YS
• Koh JM
• Kim IJ
• Kim KM
• Min YK
• Park KD
• Dinavahi R
• Maddox J
• Yang W
• Kim S
• Lee SJ
• Cho H
• Lim SK

• KMID: 2513290
• DOI: http://doi.org/10.3803/EnM.2020.848

Abstract

Background
This phase 3 study evaluated the efficacy and safety of 6-month treatment with romosozumab in Korean postmenopausal women with osteoporosis.
Methods
Sixty-seven postmenopausal women with osteoporosis (bone mineral density [BMD] T-scores ≤–2.5 at the lumbar spine, total hip, or femoral neck) were randomized (1:1) to receive monthly subcutaneous injections of romosozumab (210 mg; n=34) or placebo (n=33) for 6 months.
Results
At month 6, the difference in the least square (LS) mean percent change from baseline in lumbar spine BMD (primary efficacy endpoint) between the romosozumab (9.5%) and placebo (–0.1%) groups was significant (9.6%; 95% confidence interval, 7.6 to 11.5; P<0.001). The difference in the LS mean percent change from baseline was also significant for total hip and femoral neck BMD (secondary efficacy endpoints). After treatment with romosozumab, the percent change from baseline in procollagen type 1 N-terminal propeptide transiently increased at months 1 and 3, while that in C-terminal telopeptide of type 1 collagen showed a sustained decrease. No events of cancer, hypocalcemia, injection site reaction, positively adjudicated atypical femoral fracture or osteonecrosis of the jaw, or positively adjudicated serious cardiovascular adverse events were observed. At month 9, 17.6% and 2.9% of patients in the romosozumab group developed binding and neutralizing antibodies, respectively.
Conclusion
Treatment with romosozumab for 6 months was well tolerated and significantly increased lumbar spine, total hip, and femoral neck BMD compared with placebo in Korean postmenopausal women with osteoporosis (ClinicalTrials.gov identifier NCT02791516).

Keyword

Bone density; Bone turnover markers; Korea; Randomized controlled trial; Romosozumab

Figure

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  Fig. 1 Study design. IP, investigational product; D, day; M, month; SC, subcutaneous; QM, once monthly.

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  Fig. 2 Patient disposition. BMD, bone mineral density; BTM, bone turnover marker.

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  Fig. 3 Percent change (least square mean and 95% confidence interval) from baseline in dual-energy X-ray absorptiometry (DXA) bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck at month 6.

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  Fig. 4 Median (interquartile range) percent change from baseline in (A) procollagen type 1 N-terminal propeptide (P1NP) and (B) serum C-terminal telopeptide of type 1 collagen (CTX) by visit. SC, subcutaneous; QM, once monthly.

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