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J Bone Miner Metab. 2019 Oct 4. doi: 10.1007/s00774-019-01050-8. [Epub ahead of print]

Efficacy of non-steroidal anti-inflammatory drugs on zoledronic acid-induced acute-phase reactions: randomized, open-label, Japanese OZ study.

Author information

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.

KEYWORDS:

Acute-phase reaction; Bisphosphonate; Loxoprofen; Osteoporosis; Zoledronic acid

PMID:
31586241
DOI:
10.1007/s00774-019-01050-8

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