Nobukazu Okimoto1, Akinori Sakai2, Toru Yoshioka3, Tomohiro Kobayashi3, Kei Asano3, Shojiro Akahoshi4, Toru Ishikura4, Shito Fukuhara4, Yoshifumi Fuse5, Toshiyuki Mizuno6, Yuji Katae7, Hidehiro Matsumoto8, Takayuki Ogawa9, Shigeki Nishida10, Satoshi Ikeda11, Kunitaka Menuki2, Jun Saito12, Yuichi Okazaki13, Naoyuki Mizuno14, Saeko Fujiwara15. 1. Okimoto Clinic, 185-4 Kubi, Yutaka-machi, Kure, Hiroshima, 734-0304, Japan. noboki4@yahoo.co.jp. 2. Department of Orthopedic Surgery, School of Medicine, University of Occupational and Environmental Health, Fukuoka, 807-8555, Japan. 3. Department of Orthopedic Surgery, Shimura Hospital, 3-13 Funairimachi, Naka-ku, Hiroshima, 730-0841, Japan. 4. Department of Orthopedic Surgery, Obase Hospital, 1598 Aratsu, Kandamachi, Miyako, Fukuoka, 800-0344, Japan. 5. Department of Orthopedic Surgery, Saka Midorii Hospital, 6-28-1 Midorii, Asaminami-ku, Hiroshima, 731-0103, Japan. 6. Department of Orthopedic Surgery, Shobara Red Cross Hospital, 2-7-10 Nishihonmachi, Shobara, Hiroshima, 727-0013, Japan. 7. Department of Orthopedic Surgery, Akaike Kyodo Clinic, 521Akaike, Fukuchimachi, Tagawa, Fukuoka, 822-1101, Japan. 8. Department of Orthopedic Surgery, Sanzai Hospital, 3378 Shimosanzai, Saito, Miyazaki, 881-0113, Japan. 9. Department of Orthopedic Surgery, Kaisei General Hospital, 3-5-28 Muromachi, Sakaide, Kagawa, 762-0007, Japan. 10. Department of Orthopedic Surgery, Shin-Kokura Hospital, 1-3-1 Kanada, Kokurakita-ku, Kitakyushu, Fukuoka, 803-8505, Japan. 11. Department of Orthopedic Surgery, Ken-Ai Memorial Hospital, 1191 Kimori, Onga-cho, Onga, Fukuoka, 811-4313, Japan. 12. Department of Orthopedic Surgery, Shunankogen Hospital, 29-1 Susumahongo, Shunan, Yamaguchi, 745-0122, Japan. 13. Department of Orthopedic Surgery, Tobata General Hospital, 1-3-33 Fukuryugi, Tobata, Kitakyushu, Fukuoka, 804-0025, Japan. 14. Department of Orthopedic Surgery, Saiseikai Kure Hospital, 2-1-13 Sanjyo, Kure, Hiroshima, 737-0821, Japan. 15. Department of Pharmacy, Yasuda Women's University, 6-13-1 Yasuhigashi, Asaminami-ku, Hiroshima, 731-0153, Japan.
Abstract
INTRODUCTION:Zoledronic acid infusion is used to treat osteoporosis but patients, especially Japanese patients, often experience acute-phase reactions (APRs). In this multicenter, randomized, open-label, parallel-group study, we examined the efficacy of the most commonly used non-steroidal anti-inflammatory drug loxoprofen in Japan in reducing the incidence rate of zoledronic acid-induced APRs and body temperature, and investigated risk/protective factors for APRs in this population. MATERIALS AND METHODS:Patients aged ≥ 60 years with primary osteoporosis (n = 368) were allocated randomly to zoledronic acid plus loxoprofen (ZOL + LOX) or zoledronic acid alone (ZOL). All patients received 5-mg zoledronic acid infusion on day 1, and patients in the ZOL + LOX group also received 120 mg and 180 mg of oral loxoprofen on days 1 and 2, respectively. Adverse events and body temperature were recorded during the 7-day observation period. RESULTS: The incidence rates of APRs were 34.4% (64/186 patients) and 47.8% (87/182 patients) in the ZOL + LOX and ZOL groups, respectively (P = 0.0109). The proportions of patients with increased body temperature (≥ 1 °C and ≥ 37.5 °C) were similar in both groups (P = 0.1186). Past bisphosphonate users had a significantly lower incidence rate of APRs than treatment-naïve patients (odds ratio 0.444, 95% confidence interval 0.285-0.692, P = 0.0003). CONCLUSIONS:Zoledronic acid-induced APRs appeared to be suppressed by loxoprofen. Known risk/protective factors, including prior osteoporosis treatment, were applicable to Japanese patients.
RCT Entities:
INTRODUCTION:Zoledronic acid infusion is used to treat osteoporosis but patients, especially Japanese patients, often experience acute-phase reactions (APRs). In this multicenter, randomized, open-label, parallel-group study, we examined the efficacy of the most commonly used non-steroidal anti-inflammatory drug loxoprofen in Japan in reducing the incidence rate of zoledronic acid-induced APRs and body temperature, and investigated risk/protective factors for APRs in this population. MATERIALS AND METHODS:Patients aged ≥ 60 years with primary osteoporosis (n = 368) were allocated randomly to zoledronic acid plus loxoprofen (ZOL + LOX) or zoledronic acid alone (ZOL). All patients received 5-mg zoledronic acid infusion on day 1, and patients in the ZOL + LOX group also received 120 mg and 180 mg of oral loxoprofen on days 1 and 2, respectively. Adverse events and body temperature were recorded during the 7-day observation period. RESULTS: The incidence rates of APRs were 34.4% (64/186 patients) and 47.8% (87/182 patients) in the ZOL + LOX and ZOL groups, respectively (P = 0.0109). The proportions of patients with increased body temperature (≥ 1 °C and ≥ 37.5 °C) were similar in both groups (P = 0.1186). Past bisphosphonate users had a significantly lower incidence rate of APRs than treatment-naïve patients (odds ratio 0.444, 95% confidence interval 0.285-0.692, P = 0.0003). CONCLUSIONS:Zoledronic acid-induced APRs appeared to be suppressed by loxoprofen. Known risk/protective factors, including prior osteoporosis treatment, were applicable to Japanese patients.
Authors: Chiara Crotti; Nelson B Watts; Maria De Santis; Angela Ceribelli; Gianluigi Fabbriciani; Francesca Cavaciocchi; Bianca Marasini; Carlo Selmi; Marco Massarotti Journal: Endocr Pract Date: 2018-03-02 Impact factor: 3.443
Authors: Dennis M Black; Pierre D Delmas; Richard Eastell; Ian R Reid; Steven Boonen; Jane A Cauley; Felicia Cosman; Péter Lakatos; Ping Chung Leung; Zulema Man; Carlos Mautalen; Peter Mesenbrink; Huilin Hu; John Caminis; Karen Tong; Theresa Rosario-Jansen; Joel Krasnow; Trisha F Hue; Deborah Sellmeyer; Erik Fink Eriksen; Steven R Cummings Journal: N Engl J Med Date: 2007-05-03 Impact factor: 91.245
Authors: Pierre D Delmas; Michael R McClung; José R Zanchetta; Artur Racewicz; Christian Roux; Claude-Laurent Benhamou; Zulema Man; Rachelle A Eusebio; John F Beary; David E Burgio; Ellen Matzkin; Steven Boonen Journal: Bone Date: 2007-09-08 Impact factor: 4.398
Authors: T Nakamura; M Fukunaga; T Nakano; H Kishimoto; M Ito; H Hagino; T Sone; A Taguchi; S Tanaka; M Ohashi; Y Ota; M Shiraki Journal: Osteoporos Int Date: 2016-09-08 Impact factor: 4.507