drugset / Trial / NCT01522521
Study of AK156 in Primary Osteoporosis Patients
RandomizedParallel-groupQuadruple-blindTreatment
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
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 carbonate | Other / unclassified | — | — |
| Background | Vitamin D | Other / unclassified | — | — |