Cited by 2,003Bone health and osteoporosis researchBone health and treatmentsHip and Femur Fractures

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Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture

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Lyles, Kenneth W., Colón-Emeric, Cathleen S., Magaziner, Jay S., Adachi, Jonathan D., Pieper, Carl F., Mautalen, Carlos, Hyldstrup, Lars, Recknor, Chris, Nordsletten, Lars, Moore, Kathy A., Lavecchia, Catherine, Zhang, Jie, Mesenbrink, Peter, Hodgson, Patricia K., Abrams, Ken, Orloff, John J., Horowitz, Zebulun, Eriksen, Erik Fink, Boonen, Steven·2007·New England Journal of Medicine

DOI 10.1056/nejmoa074941PMC PMC2324066

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Abstract

BACKGROUND: Mortality is increased after a hip fracture, and strategies that improve outcomes are needed. METHODS: In this randomized, double-blind, placebo-controlled trial, 1065 patients were assigned to receive yearly intravenous zoledronic acid (at a dose of 5 mg), and 1062 patients were assigned to receive placebo. The infusions were first administered within 90 days after surgical repair of a hip fracture. All patients (mean age, 74.5 years) received supplemental vitamin D and calcium. The median follow-up was 1.9 years. The primary end point was a new clinical fracture. RESULTS: The rates of any new clinical fracture were 8.6% in the zoledronic acid group and 13.9% in the placebo group, a 35% risk reduction with zoledronic acid (P=0.001); the respective rates of a new clinical vertebral fracture were 1.7% and 3.8% (P=0.02), and the respective rates of new nonvertebral fractures were 7.6% and 10.7% (P=0.03). In the safety analysis, 101 of 1054 patients in the zoledronic acid group (9.6%) and 141 of 1057 patients in the placebo group (13.3%) died, a reduction of 28% in deaths from any cause in the zoledronic acid group (P=0.01). The most frequent adverse events in patients receiving zoledronic acid were pyrexia, myalgia, and bone and musculoskeletal pain. No cases of osteonecrosis of the jaw were reported, and no adverse effects on the healing of fractures were noted. The rates of renal and cardiovascular adverse events, including atrial fibrillation and stroke, were similar in the two groups. CONCLUSIONS: An annual infusion of zoledronic acid within 90 days after repair of a low-trauma hip fracture was associated with a reduction in the rate of new clinical fractures and with improved survival. (ClinicalTrials.gov number, NCT00046254 [ClinicalTrials.gov].).

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Authors: Lyles, K. W., Colón-Emeric, C. S., Magaziner, J. S., Adachi, J. D., Pieper, C. F., Mautalen, C., Hyldstrup, L., Recknor, C., Nordsletten, L., Moore, K. A., Lavecchia, C., Zhang, J., Mesenbrink, P., Hodgson, P. K., Abrams, K., Orloff, J. J., Horowitz, Z., Eriksen, E. F., & Boonen, S.
Affiliations: Veterans Health Administration (US)
University of Maryland, Baltimore (US)
McMaster University (CA)
Duke Medical Center (US)
Hvidovre Hospital (DK)
Oslo University Hospital (NO)
Savient Pharmaceuticals (United States) (US)
Novartis (Switzerland) (CH)
KU Leuven (BE)
ORCID: Magaziner, Jay S.
Adachi, Jonathan D.
Pieper, Carl F.
Nordsletten, Lars
Zhang, Jie
Mesenbrink, Peter
Eriksen, Erik Fink
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2007-11
Volume: 357
Issue: 18
Pages: 1799-1809
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa074941
PMC: PMC2324066
OpenAlex: W2163830908
Cited by: 2,003
References: 35
Citations by year: 2026: 53 · 2025: 88 · 2024: 67 · 2023: 75 · 2022: 78 · 2021: 119 · 2020: 104 · 2019: 94 · 2018: 92 · 2017: 79 · 2016: 97 · 2015: 92 · 2014: 106 · 2013: 115 · 2012: 122
FWCI: 160.83
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
PubMed Central (acceptedVersion)
IRIS (submittedVersion)
SERVAL (Université de Lausanne) (submittedVersion)
Funders: Amgen
Eli Lilly and Company
Pfizer
GlaxoSmithKline
Sanofi
Savient Pharmaceuticals
Novo Nordisk
Servier
National Institute on Aging (K23AG024787)
Topics: Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
Health Sciences › Medicine › Oncology › Bone health and treatments
Health Sciences › Medicine › Surgery › Hip and Femur Fractures
Keywords: zoledronic acid, hip fracture, bisphosphonates, fracture prevention, vertebral fractures, non-vertebral fractures, mortality, postoperative treatment, osteoporosis, adverse events, osteonecrosis of the jaw
MeSH terms: Zoledronic Acid, Aged, Aged, 80 and over, Calcium, Diphosphonates, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Hip Fractures, Humans, Imidazoles, Infusions, Intravenous, Male, Middle Aged, Vitamin D, Bone Density, Survival Analysis, Bone Density Conservation Agents, Fractures, Bone

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Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture

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