Clinical trial NCT01522521: Study of AK156 in Primary Osteoporosis Patients
Official title: Phase 3 Study of AK156 in Primary Osteoporosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: AK156
Lead sponsor: Asahi Kasei Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-01-31
Enrollment: 600
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with primary osteoporosis
* Patients who have vertebral fractures at the time of screening

Exclusion Criteria:

* Patients diagnosed with secondary osteoporosis
* Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study

Primary outcomes:
measure: New vertebral fractures
timeFrame: 2 Years
Secondary outcomes:
measure: Vertebral fractures (worsening and new)
timeFrame: 2 Years
measure: Clinical fractures
timeFrame: 2 Years
measure: Bone mineral density
timeFrame: 2 Years
measure: Bone metabolic marker
timeFrame: 2 Years
Other outcomes:
Locations:
city: Kure
country: Japan
state: Hiroshima
city: Sapporo
country: Japan
state: Hokkaido
city: Inami-cho
country: Japan
state: Hyogo
city: Morioka
country: Japan
state: Iwate
city: Yokohama
country: Japan
state: Kanagawa
city: Sendai
country: Japan
state: Miyagi
city: Matsumoto
country: Japan
state: Nagano
city: Bungo-Ono
country: Japan
state: Oita
city: Tosu
country: Japan
state: Saga
city: Tokorozawa
country: Japan
state: Saitama
city: Kikukawa
country: Japan
state: Shizuoka
city: Oyama
country: Japan
state: Tochigi
city: Setagaya
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
city: Tonami
country: Japan
state: Toyama
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Kagoshima
country: Japan
city: Kumamoto
country: Japan
city: Miyazaki
country: Japan
Study officials:
affiliation: Clinical Development Center
name: Asahi Kasei Pharma Corporation
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.