Skip to main content
Erschienen in: Journal of Bone and Mineral Metabolism 5/2021

05.04.2021 | Original Article

Short-term efficacy and safety of zoledronate acid or denosumab in Japanese patients with postmenopausal osteoporosis

verfasst von: Yumejiro Nakamura, Tomohiro Shimizu, Tsuyoshi Asano, Shun Shimodan, Hotaka Ishizu, Daisuke Takahashi, Masahiko Takahata, Norimasa Iwasaki

Erschienen in: Journal of Bone and Mineral Metabolism | Ausgabe 5/2021

Einloggen, um Zugang zu erhalten

Abstract

Introduction

We aimed to compare the efficacy after switching from either bisphosphonates (BPs) or non-BPs (NBPs) to combination therapies of denosumab (DMAb) or zoledronic acid (Zol) with eldecalcitol (ELD) in bone mineral density (BMD) and bone metabolism and investigate the prognostic and risk factors of side effects of this therapy.

Materials and methods

One-hundred forty-eight patients with postmenopausal osteoporosis were recruited; their therapy was switched from BPs or NBPs to Zol or DMAb plus ELD (BP-Zol: 43, NBP-Zol: 32, BP-DMAb: 35, and NBP-DMAb: 38). Longitudinal changes in bone metabolic markers (P1NP and TRACP-5b) and BMD were evaluated.

Results

In the BP-Zol group, P1NP did not change after 6 months and increased by 38.9% after 12 months. TRACP-5b decreased 15.8% after 6 months, but came back to baseline values 12 months after administration. In the rest of the groups, the bone metabolic markers remained suppressed after 6 and 12 months. Compared with baseline, all groups showed increase in BMD after 6 and 12 months. Bone metabolic markers at baseline were correlated with %change in lumbar spine BMD from baseline to 12 months. P1NP and 25-hydroxy vitamin D levels at baseline were identified as potential predictors of development of acute-phase reactions.

Conclusions

The combination therapy of Zol or DMAb and ELD may increase BMD at 12 months after the first administration in Japanese patients with postmenopausal osteoporosis, regardless of BPs pretreatment. Bone metabolic markers at baseline may be useful predictors for reaction to the therapy and side effects caused by these combination therapies in postmenopausal osteoporosis.
Literatur
2.
Zurück zum Zitat Who are candidates for prevention and treatment for osteoporosis? (1997). Osteoporos Int 7:1–6 Who are candidates for prevention and treatment for osteoporosis? (1997). Osteoporos Int 7:1–6
13.
Zurück zum Zitat Brown JP, Prince RL, Deal C, Recker RR, Kiel DP, de Gregorio LH, Hadji P, Hofbauer LC, Alvaro-Gracia JM, Wang H, Austin M, Wagman RB, Newmark R, Libanati C, San Martin J, Bone HG (2009) Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial. J Bone Miner Res 24:153–161. https://doi.org/10.1359/jbmr.08090110.1359/jbmr.0809010CrossRefPubMed Brown JP, Prince RL, Deal C, Recker RR, Kiel DP, de Gregorio LH, Hadji P, Hofbauer LC, Alvaro-Gracia JM, Wang H, Austin M, Wagman RB, Newmark R, Libanati C, San Martin J, Bone HG (2009) Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial. J Bone Miner Res 24:153–161. https://​doi.​org/​10.​1359/​jbmr.​08090110.​1359/​jbmr.​0809010CrossRefPubMed
14.
Zurück zum Zitat Brown JP, Roux C, Ho PR, Bolognese MA, Hall J, Bone HG, Bonnick S, van den Bergh JP, Ferreira I, Dakin P, Wagman RB, Recknor C (2014) Denosumab significantly increases bone mineral density and reduces bone turnover compared with monthly oral ibandronate and risedronate in postmenopausal women who remained at higher risk for fracture despite previous suboptimal treatment with an oral bisphosphonate. Osteoporos Int 25:1953–1961. https://doi.org/10.1007/s00198-014-2692-7CrossRefPubMed Brown JP, Roux C, Ho PR, Bolognese MA, Hall J, Bone HG, Bonnick S, van den Bergh JP, Ferreira I, Dakin P, Wagman RB, Recknor C (2014) Denosumab significantly increases bone mineral density and reduces bone turnover compared with monthly oral ibandronate and risedronate in postmenopausal women who remained at higher risk for fracture despite previous suboptimal treatment with an oral bisphosphonate. Osteoporos Int 25:1953–1961. https://​doi.​org/​10.​1007/​s00198-014-2692-7CrossRefPubMed
15.
Zurück zum Zitat Roux C, Hofbauer LC, Ho PR, Wark JD, Zillikens MC, Fahrleitner-Pammer A, Hawkins F, Micaelo M, Minisola S, Papaioannou N, Stone M, Ferreira I, Siddhanti S, Wagman RB, Brown JP (2014) Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study. Bone 58:48–54. https://doi.org/10.1016/j.bone.2013.10.006CrossRefPubMed Roux C, Hofbauer LC, Ho PR, Wark JD, Zillikens MC, Fahrleitner-Pammer A, Hawkins F, Micaelo M, Minisola S, Papaioannou N, Stone M, Ferreira I, Siddhanti S, Wagman RB, Brown JP (2014) Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study. Bone 58:48–54. https://​doi.​org/​10.​1016/​j.​bone.​2013.​10.​006CrossRefPubMed
18.
Zurück zum Zitat Nakamura T, Fukunaga M, Nakano T, Kishimoto H, Ito M, Hagino H, Sone T, Taguchi A, Tanaka S, Ohashi M, Ota Y, Shiraki M (2017) Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study). Osteoporos Int 28:389–398. https://doi.org/10.1007/s00198-016-3736-yCrossRefPubMed Nakamura T, Fukunaga M, Nakano T, Kishimoto H, Ito M, Hagino H, Sone T, Taguchi A, Tanaka S, Ohashi M, Ota Y, Shiraki M (2017) Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study). Osteoporos Int 28:389–398. https://​doi.​org/​10.​1007/​s00198-016-3736-yCrossRefPubMed
27.
28.
Zurück zum Zitat Okimoto N, Sakai A, Yoshioka T, Kobayashi T, Asano K, Akahoshi S, Ishikura T, Fukuhara S, Fuse Y, Mizuno T, Katae Y (2020) Efficacy of non-steroidal anti-inflammatory drugs on zoledronic acid-induced acute-phase reactions: randomized, open-label, Japanese OZ study. J Bone Miner Metab 38:230–239. https://doi.org/10.1007/s00774-019-01050-8CrossRefPubMed Okimoto N, Sakai A, Yoshioka T, Kobayashi T, Asano K, Akahoshi S, Ishikura T, Fukuhara S, Fuse Y, Mizuno T, Katae Y (2020) Efficacy of non-steroidal anti-inflammatory drugs on zoledronic acid-induced acute-phase reactions: randomized, open-label, Japanese OZ study. J Bone Miner Metab 38:230–239. https://​doi.​org/​10.​1007/​s00774-019-01050-8CrossRefPubMed
33.
39.
Zurück zum Zitat Bertoldo F, Pancheri S, Zenari S, Boldini S, Giovanazzi B, Zanatta M, Valenti MT, Dalle Carbonare L, Lo Cascio V (2010) Serum 25-hydroxyvitamin D levels modulate the acute-phase response associated with the first nitrogen-containing bisphosphonate infusion. J Bone Miner Res 25:447–454. https://doi.org/10.1359/jbmr.090819CrossRefPubMed Bertoldo F, Pancheri S, Zenari S, Boldini S, Giovanazzi B, Zanatta M, Valenti MT, Dalle Carbonare L, Lo Cascio V (2010) Serum 25-hydroxyvitamin D levels modulate the acute-phase response associated with the first nitrogen-containing bisphosphonate infusion. J Bone Miner Res 25:447–454. https://​doi.​org/​10.​1359/​jbmr.​090819CrossRefPubMed
Metadaten
Titel
Short-term efficacy and safety of zoledronate acid or denosumab in Japanese patients with postmenopausal osteoporosis
verfasst von
Yumejiro Nakamura
Tomohiro Shimizu
Tsuyoshi Asano
Shun Shimodan
Hotaka Ishizu
Daisuke Takahashi
Masahiko Takahata
Norimasa Iwasaki
Publikationsdatum
05.04.2021
Verlag
Springer Singapore
Erschienen in
Journal of Bone and Mineral Metabolism / Ausgabe 5/2021
Print ISSN: 0914-8779
Elektronische ISSN: 1435-5604
DOI
https://doi.org/10.1007/s00774-021-01221-6

Weitere Artikel der Ausgabe 5/2021

Journal of Bone and Mineral Metabolism 5/2021 Zur Ausgabe

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Echinokokkose medikamentös behandeln oder operieren?

06.05.2024 DCK 2024 Kongressbericht

Die Therapie von Echinokokkosen sollte immer in spezialisierten Zentren erfolgen. Eine symptomlose Echinokokkose kann – egal ob von Hunde- oder Fuchsbandwurm ausgelöst – konservativ erfolgen. Wenn eine Op. nötig ist, kann es sinnvoll sein, vorher Zysten zu leeren und zu desinfizieren. 

Umsetzung der POMGAT-Leitlinie läuft

03.05.2024 DCK 2024 Kongressbericht

Seit November 2023 gibt es evidenzbasierte Empfehlungen zum perioperativen Management bei gastrointestinalen Tumoren (POMGAT) auf S3-Niveau. Vieles wird schon entsprechend der Empfehlungen durchgeführt. Wo es im Alltag noch hapert, zeigt eine Umfrage in einem Klinikverbund.

Proximale Humerusfraktur: Auch 100-Jährige operieren?

01.05.2024 DCK 2024 Kongressbericht

Mit dem demographischen Wandel versorgt auch die Chirurgie immer mehr betagte Menschen. Von Entwicklungen wie Fast-Track können auch ältere Menschen profitieren und bei proximaler Humerusfraktur können selbst manche 100-Jährige noch sicher operiert werden.

Die „Zehn Gebote“ des Endokarditis-Managements

30.04.2024 Endokarditis Leitlinie kompakt

Worauf kommt es beim Management von Personen mit infektiöser Endokarditis an? Eine Kardiologin und ein Kardiologe fassen die zehn wichtigsten Punkte der neuen ESC-Leitlinie zusammen.

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.