ISSN: 2167-0870
Kunitaka Menuki
Japan
Protocol Article
Design of a Multicenter, Randomized, Open Label, Parallel Group Study to Evaluate the Efficacy of Loxoprofen on Acute-Phase Reactions in Japanese Primary Osteoporosis Patients Treated with Zoledronic Acid
Author(s): Nobukazu Okimoto, Akinori Sakai, Hidehiro Matsumoto, Satoshi Ikeda, Kunitaka Menuki, Toru Yoshioka, Tomohiro Kobayashi, Toru Ishikura and Saeko Fujiwara
Nobukazu Okimoto, Akinori Sakai, Hidehiro Matsumoto, Satoshi Ikeda, Kunitaka Menuki, Toru Yoshioka, Tomohiro Kobayashi, Toru Ishikura and Saeko Fujiwara
Treatment of osteoporosis with once-yearly zoledronic acid was approved in September 2016 in Japan. Like other bisphosphonates, zoledronic acid causes acute-phase responses (APRs), which are more severe in Asian populations than in multinational populations. The aim of this multicenter, randomized, open label, parallel group study is to investigate the incidence of APRs in Japanese patients with primary osteoporosis in real clinical settings, and to test the hypotheses that APRs are suppressed by administering one of the most commonly used nonsteroidal anti-inflammatory drugs in Japan, loxoprofen, immediately after the treatment with zoledronic acid, and the incidence of APRs in patients with prior history of treatment with bisphosphonate is lower than that in naïve patients. A total of 400 patients aged 60 or older were randomly allocated to a zoledronic acid plus loxoprofen gro.. View More»
DOI:
10.4172/2167-0870.1000336