Factors associated with acute-phase response of bisphosphonate-naïve or pretreated women with osteoporosis receiving an intravenous first dose of zoledronate or ibandronate

Summary A first intravenous dose of bisphosphonates may be associated with an acute-phase response (APR). In bisphosphonate-naïve women with postmenopausal osteoporosis, the characteristics and frequency of APR may differ by compound. Prior bisphosphonate exposure was predictive of APR risk and seve...

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Published in:	Osteoporosis international Vol. 28; no. 6; pp. 1995 - 2002
Main Authors:	Popp, A.W., Senn, R., Curkovic, I., Senn, C., Buffat, H., Popp, P.F., Lippuner, K.
Format:	Journal Article
Language:	English
Published:	London Springer London 01-06-2017 Springer Nature B.V
Subjects:	Acute-Phase Reaction - chemically induced Aged Arthralgia Bisphosphonates Bone Density Conservation Agents - administration & dosage Bone Density Conservation Agents - adverse effects Bone Density Conservation Agents - therapeutic use Clinical trials Diphosphonates - administration & dosage Diphosphonates - adverse effects Diphosphonates - therapeutic use Endocrinology Female Humans Ibandronic acid Imidazoles - administration & dosage Imidazoles - adverse effects Imidazoles - therapeutic use Infusions, Intravenous Intravenous administration Medicine Medicine & Public Health Middle Aged Myalgia Original Article Orthopedics Osteoporosis Osteoporosis, Postmenopausal - drug therapy Post-menopause Prospective Studies Rheumatology Risk Factors Severity of Illness Index Vitamin D Zoledronic acid Acute-phase response Postmenopausal osteoporosis Zoledronate Ibandronate
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Summary:	Summary A first intravenous dose of bisphosphonates may be associated with an acute-phase response (APR). In bisphosphonate-naïve women with postmenopausal osteoporosis, the characteristics and frequency of APR may differ by compound. Prior bisphosphonate exposure was predictive of APR risk and severity. Introduction Intravenous (IV) administration of bisphosphonates (BP), such as zoledronate (ZOL) and ibandronate (IBN), may be associated with an APR. The characteristics of APR may differ by compound. The aim of the present study was to evaluate the characteristics of APR (rates, signs and symptoms, severity), in the absence of any preventive measure, after a first IV application of ZOL or IBN in patients naïve or previously exposed to BP in a real-world clinical setting. Methods This is an open-label prospective exploratory study with two cohorts of consecutive postmenopausal women with osteoporosis treated with either IV ZOL or IBN at the Department of Osteoporosis of the University Hospital of Berne, Switzerland. Results Intravenous BP was administered to 725 women (411 ZOL and 314 IBN). Prior oral or IV BP use was less frequent in the ZOL group (61.8 vs. 71.7%, p = 0.005). In total, 301 women (41.5%) reported the presence of one or more signs or symptoms of APR with rates for ZOL and IBN of 47.7 and 33.4%, respectively ( p < 0.001). Corresponding APR rates in the subgroup of BP-naïve patients were 55.6 and 32.4%, respectively ( p < 0.001). The leading APR clinical sign was the presence of post-dose myalgia or arthralgia (68.1%). Prior BP exposure was predictive of both APR risk and severity, and lower serum 25-hydroxy vitamin D (25(OH)D) levels were possibly predictive of severity. Conclusions In a real-world setting, APR rates with ZOL and IBN may be higher than reported in randomised controlled trials and may differ by compound, prior BP exposure, and serum 25(OH)D levels.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	0937-941X 1433-2965
DOI:	10.1007/s00198-017-3992-5