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The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. | Experimental |
| |
| 2. | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK156 | Drug | zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years |
| |
| Measure | Description | Time Frame |
|---|---|---|
| New vertebral fractures | Reduction in the incidence rate of new fragility vertebral fractures | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Vertebral fractures (worsening and new) | The incidence rate of fragility vertebral fractures (worsening and new) | 2 Years |
| Clinical fractures | The incidence rate of Clinical fractures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asahi Kasei Pharma Corporation | Clinical Development Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba | Chiba | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34247263 | Derived | 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. | |
| 31688575 |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| Placebo |
| Drug |
placebo (i.v.)/year + daily calcium and vitamin D for 2 years |
|
| 2 Years |
| Bone mineral density | The percent change from baseline in bone mineral density of lumbar spine and hip | 2 Years |
| Bone metabolic marker | The percent change from baseline in bone metabolic marker | 2 Years |
| 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 |
| 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. |
| 27631091 | Derived | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |