Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2012-02-29
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1.
AK156
zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years
2.
Placebo
placebo (i.v.)/year + daily calcium and vitamin D for 2 years
Interventions
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AK156
zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years
Placebo
placebo (i.v.)/year + daily calcium and vitamin D for 2 years
Eligibility Criteria
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Inclusion Criteria
* Patients who have vertebral fractures at the time of screening
Exclusion Criteria
* Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study
65 Years
89 Years
ALL
No
Sponsors
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Asahi Kasei Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Asahi Kasei Pharma Corporation
Role: STUDY_DIRECTOR
Clinical Development Center
Locations
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Chiba, Chiba, Japan
Fukuoka, Fukuoka, Japan
Kure, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Inami-cho, Hyōgo, Japan
Morioka, Iwate, Japan
Kagoshima, Kagoshima-ken, Japan
Yokohama, Kanagawa, Japan
Kumamoto, Kumamoto, Japan
Sendai, Miyagi, Japan
Miyazaki, Miyazaki, Japan
Matsumoto, Nagano, Japan
Bungo-ōno, Oita Prefecture, Japan
Tosu, Saga-ken, Japan
Tokorozawa, Saitama, Japan
Kikukawa, Shizuoka, Japan
Oyama, Tochigi, Japan
Setagaya City, Tokyo, Japan
Shinagawa, Tokyo, Japan
Tonami, Toyama, Japan
Countries
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References
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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.
Other Identifiers
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AK156 III-1
Identifier Type: -
Identifier Source: org_study_id
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