Characterization of and Risk Factors for the Acute-Phase Response after Zoledronic Acid

Reid, Ian R.; Gamble, Greg; Mesenbrink, Peter; Lakatos, Péter L.; Black, Dennis M.

doi:10.1210/jc.2010-0597

Cited by 220 publications

(180 citation statements)

References 19 publications

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“…88 There was evidence that the risk of eye inflammation in the first 3 days following drug administration was significantly greater in those receiving zoledronic acid than in those receiving placebo. 102 Evidence from a single RCT indicated that the incidence of stroke over 36 months does not differ significantly among individuals receiving zoledronic acid and those receiving placebo. 77 All RCTs evaluating zoledronic acid reported no cases of spontaneous osteonecrosis of the jaw in any treatment group during the trial period.…”

Section: Discussionmentioning

confidence: 99%

“…Similar results were observed in the BONE trial 45 and the trial by McClung et al, 80 in which abdominal pain and dyspepsia were the most common upper GI events, accounting for 11.4% (111/977) of upper GI events in the group receiving 5 mg ibandronic acid daily and 31.2% (24/77) in the group receiving 150 mg ibandronic acid monthly. Of the 300 upper GI events occurring in participants on 5 mg of zoledronic acid in two RCTs, 88,102 nausea was the major event, with 168 reports (56.0%), followed by vomiting with 76 (25.3%), diarrhoea with 67 (22.3%), abdominal pain with 48 (16.0%) and anorexia with 45 (15.0%). However, the proportion of these upper GI events was similar in the treatment group and the placebo group, but less frequent in the zoledronic acid group.…”

Section: Any Upper Gastrointestinal Adverse Eventsmentioning

confidence: 99%

“…However, the proportion of these upper GI events was similar in the treatment group and the placebo group, but less frequent in the zoledronic acid group. 102 Alendronic acid Six RCTs reporting upper GI AEs evaluated 10 mg per day of alendronic acid in postmenopausal women 55,57,64,67,84,91 and one investigated 10 mg per day of alendronic acid in men with osteoporosis. 83 Pooled data across all seven RCTs indicated no statistically significant difference between treatments in the incidence of upper GI AEs.…”

Section: Any Upper Gastrointestinal Adverse Eventsmentioning

confidence: 99%

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Corrigendum: A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures

Davis

James

Sanderson

et al. 2018

Health Technol Assess

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During the course of providing additional analyses for the National Institute for Health and Care Excellence Technology Appraisal Committee, two errors were identified in the data entered in the network meta-analysis that informed the cost-effectiveness analysis described in the original report. This corrigendum notice describes the errors identified and the impact of correcting these errors on the main analyses presented in the original report.

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Section: Discussionmentioning

confidence: 99%

Section: Any Upper Gastrointestinal Adverse Eventsmentioning

confidence: 99%

Section: Any Upper Gastrointestinal Adverse Eventsmentioning

confidence: 99%

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Corrigendum: A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures

Davis

James

Sanderson

et al. 2018

Health Technol Assess

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“…The highest risk of developing APRs was reported in the non-Japanese Asians and Pacific Islanders (odds ratio: 2.20 and 3.39) [3].…”

Section: Introductionmentioning

confidence: 92%

“…The Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly Pivotal Fracture Trial (HORIZON-PFT) and subsequent sub-analyses have shown a higher incidence of APRs in the Asian populations compared to those in the multinational populations included in the studies [1,3,4]. A sub-analysis of the HORIZON-PFT showed that the incidences of pyrexia and arthralgia in the Chinese population were higher than those in the multinational population, of which 14.2% were Asians (pyrexia, 28.2 vs. 16.1%; arthralgia, 21.5 vs.…”

Section: Introductionmentioning

confidence: 99%

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

Okimoto¹,

Sakai²,

Matsumoto³

et al. 2017

J Clin Trials

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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 group or zoledronic acid group on a 1:1 basis. After the treatment, patients were observed for 7 days, during which patients will record APRs for the first 3 days, and body temperature and drugs taken for 7 days. Primary endpoints are incidence of APRs and increase in body temperature, and secondary endpoints are relationship between prior treatment for osteoporosis in the past 3 years versus incidence of APRs, and that versus a change in body temperature. Results supporting the hypotheses will indicate that APRs are manageable with loxoprofen, which patients likely already have, and the APRs will develop less frequently and be less severe in the following years, despite the high risk of APRs in Japanese patients.

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Effect of Intravenous Zoledronic Acid on Tibiofemoral Cartilage Volume Among Patients With Knee Osteoarthritis With Bone Marrow Lesions

Cai

Aitken

Laslett

et al. 2020

JAMA

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IMPORTANCE A proof-of-principle study suggested that intravenous zoledronic acid may reduce knee pain and the size of bone marrow lesions in people with knee osteoarthritis, but data from large trials are lacking.OBJECTIVE To determine the effects of intravenous zoledronic acid on knee cartilage volume loss in patients with symptomatic knee osteoarthritis and bone marrow lesions. DESIGN, SETTING, AND PARTICIPANTSA 24-month multicenter, double-blind placebo-controlled randomized clinical trial conducted at 4 sites in Australia (1 research center and 3 hospitals). Adults aged 50 years or older with symptomatic knee osteoarthritis and subchondral bone marrow lesions detected by magnetic resonance imaging (MRI) were enrolled from November 2013 through September 2015. The final date of follow-up was October 9, 2017.INTERVENTIONS Intravenous infusion with either 5 mg of zoledronic acid in a 100-mL saline solution (n = 113) or a placebo saline solution (n = 110) at baseline and 12 months. MAIN OUTCOMES AND MEASURESThe primary outcome was absolute change in tibiofemoral cartilage volume assessed using MRI over 24 months (the minimum clinically important difference [MCID] has not been established). Three prespecified secondary outcomes were change in knee pain assessed by a visual analog scale (0 [no pain] to 100 [unbearable pain]; MCID, 15) and the Western Ontario and McMaster Universities Osteoarthritis Index (0 [no pain] to 500 [unbearable pain]; MCID, 75) over 3, 6, 12, 18, and 24 months and change in bone marrow lesion size over 6 and 24 months (the MCID has not been established). RESULTSOf 223 participants enrolled (mean age, 62.0 years [SD, 8.0 years]; 52% were female), 190 (85%) completed the trial. Change in tibiofemoral cartilage volume was not significantly different between the zoledronic acid group and the placebo group over 24 months (−878 mm 3 vs −919 mm 3 ; between-group difference, 41 mm 3 [95% CI, −79 to 161 mm 3 ]; P = .50). No significant between-group differences were found for any of the prespecified secondary outcomes, including changes in knee pain assessed by a visual analog scale (−11.5 in the zoledronic acid group vs −16.8 in the placebo group; between-group difference, 5.2 [95% CI, −2.3 to 12.8]; P = .17), changes in knee pain assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (−37.5 vs −58.0, respectively; between-group difference, 20.5 [95% CI, −11.2 to 52.2]; P = .21), and changes in bone marrow lesion size (−33 mm 2 vs −6 mm 2 ; between-group difference, −27 mm 2 [95% CI, −127 to 73 mm 2 ]; P = .60) over 24 months. Adverse events were more common with zoledronic acid than with placebo (96% vs 83%, respectively) and consisted mainly of acute reactions (defined as symptoms within 3 days of administration of infusion; 87% vs 56%).CONCLUSIONS AND RELEVANCE Among patients with symptomatic knee osteoarthritis and bone marrow lesions, yearly zoledronic acid infusions, compared with placebo, did not significantly reduce cartilage volume loss over 24 months. These finding...

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Characterization of and Risk Factors for the Acute-Phase Response after Zoledronic Acid

Abstract: This analysis identifies new components of the APR and provides the first assessment of risk factors for it. Despite its frequency, APR rarely resulted in treatment discontinuation in this study.

Cited by 220 publications

References 19 publications

Corrigendum: A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures

Corrigendum: A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures

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

Effect of Intravenous Zoledronic Acid on Tibiofemoral Cartilage Volume Among Patients With Knee Osteoarthritis With Bone Marrow Lesions

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