Effects of prior osteoporosis treatment on early treatment response of romosozumab in patients with postmenopausal osteoporosis

Ebina, Kosuke; Hirao, Makoto; Tsuboi, Hideki; Nagayama, Yoshio; Kashii, Masafumi; Kaneshiro, Shoichi; Miyama, Akira; Nakaya, Hiroyuki; Kunugiza, Yasuo; Okamura, Gensuke; Etani, Yuki; Takami, Kenji; Goshima, Atsushi; Nakata, Ken

Affiliations

¹Department of Musculoskeletal Regenerative Medicine, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

²Department of Orthopaedic Surgery, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka 565-0871, Japan

³Department of Orthopaedic Surgery, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Kita-ku, Sakai 591-8025, Japan

⁴Nagayama Rheumatology and Orthopaedic Clinic, 4-3-25 Hiokisounishi-machi, Higashi-ku, Sakai 599-8114, Japan

⁵Department of Orthopaedic Surgery, Toyonaka Municipal Hospital, 4-14-1 Shibahara-cho, Toyonaka, Osaka 560-8565, Japan

⁶Department of Orthopaedic Surgery, Osaka Toneyama Medical Center, 5-1-1 Toneyama, Toyonaka, Osaka 560-8552, Japan

⁷Department of Orthopaedic Surgery, Japan Community Health care Organization, Osaka Hospital, 4-2-78 Fukushima, Fukushima Ward, Osaka, Osaka 553-0003, Japan

⁸Department of Orthopaedic Surgery, Japan Community Health care Organization, Hoshigaoka Medical Center, 4-8-1 Hoshigaoka, Hirakata, Osaka 573-8511, Japan

⁹Department of Health and Sport Sciences, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

Abstract and keywords

Purpose: To investigate the effects of prior treatment and the predictors of early treatment response to romosozumab (ROMO) in patients with postmenopausal osteoporosis.

Methods: In this prospective, observational, multicenter study, 130 treatment-naïve patients (Naïve; n = 37) or patients previously treated with bisphosphonates (BP; n = 33), denosumab (DMAb; n = 45), or teriparatide (TPTD; n = 15) (age, 75.0 years; T-scores of the lumbar spine [LS] −3.2 and femoral neck [FN] −2.9) were switched to ROMO based on their physician's decision. Bone mineral density (BMD) and serum bone turnover markers were evaluated for six months.

Results: At six months, LS BMD changes were 13.6%, 7.5%, 3.6%, and 8.7% (P < .001 between groups) and FN BMD changes were 4.2%, 0.4%, 1.6%, and 1.5% (P = .16 between groups) for Naïve, BP, DMAb, and TPTD groups, respectively. Changes in N-terminal type I procollagen propeptide (PINP; μg/L) levels from baseline → one month were 72.7 → 139.0, 33.5 → 85.4, 30.4 → 54.3, and 98.4 → 107.4, and those of isoform 5b of tartrate-resistant acid phosphatase (TRACP-5b) (mU/dL) were 474.7 → 270.2, 277.3 → 203.7, 220.3 → 242.0, and 454.1 → 313.0 for Naïve, BP, DMAb, and TPTD groups, respectively. Multivariate regression analysis revealed that significant predictors of LS BMD change at six months were prior treatment difference (r = −3.1, P = .0027) and TRACP-5b percentage change (r = −2.8, P = .0071) and PINP value at one month (r = 3.2, P = .0021).

Conclusion: Early effects of ROMO on the increase in LS BMD are significantly affected by the difference of prior treatment and are predicted by the early change in bone turnover markers.

Mini abstract: Early effects of ROMO on the increase in LS BMD at six months is significantly affected by the difference of prior treatment and also predicted by the early change of bone turnover markers in patients with postmenopausal osteoporosis.

Keywords: Romosozumab; Prior treatment; Predictor; Bone turnover marker; Postmenopausal osteoporosis

Links

DOI: 10.1016/j.bone.2020.115574

PubMed: 32777516

WoS: 000573433100003

History

Received: 2020-06-24

Revised: 2020-08-3

Accepted: 2020-08-3

Online: 2020-08-8

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