Study of AK156 in Primary Osteoporosis Patients

Summary

The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis.

Timeline

Start

2012-02

Primary completion

2015-01

Completion

2015-01

Outcome

Met primary endpoint

paper 3.0 % (10/330 subjects) in the ZOL group and 8.9 % (29/327) in the placebo group (p = 0.0016). PMID 27631091 ↗

paper The 2-year incidence of new morphometric vertebral fracture was 3.0 % (10/330 subjects) in the ZOL group and 8.9 % (29/327) in the placebo group (p = 0.0016). PMID 27631091 ↗

Publications

• Shiraki M, Kuroda T, Takeuchi Y, Sugimoto T, Tanaka S, Suzuki H, Hiraishi K, Nakamura T. Acute Phase Reactions After Intravenous Infusion of Zoledronic Acid in Japanese Patients with Osteoporosis: Sub-analyses of the Phase III ZONE Study. Calcif Tissue Int. 2021 Dec;109(6):666-674. doi: 10.1007/s00223-021-00884-7. Epub 2021 Jul 10.
• Taguchi A, Shiraki M, Tanaka S, Ohshige H, Nakamura T. Improved periodontal disease and prevention of tooth loss in osteoporosis patients receiving once-yearly zoledronic acid: a randomized clinical trial. Menopause. 2019 Nov;26(11):1277-1283. doi: 10.1097/GME.0000000000001393.
• Nakamura T, Fukunaga M, Nakano T, Kishimoto H, Ito M, Hagino H, Sone T, Taguchi A, Tanaka S, Ohashi M, Ota Y, Shiraki M. 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. 2017 Jan;28(1):389-398. doi: 10.1007/s00198-016-3736-y. Epub 2016 Sep 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zoledronic acid	Other / unclassified	5 mg	Intravenous
Background	Calcium	Small molecule	—	—
Background	Vitamin D	Other / unclassified	—	—

Indications