Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture
Open accessAbstract
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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There are abundant data that patients with spine and hip fractures will have reduced fracture risk if treated with pharmacologic therapy.
“There are abundant data that patients with spine and hip fractures will have reduced fracture risk if treated with pharmacologic therapy.”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [58]
The Fractures section reports fewer new clinical fractures with zoledronic acid than placebo among patients treated after a hip fracture (8.6% versus 13.9%). The paper does not establish the same result for patients with prior spine fractures or for pharmacologic therapy generally, so the claim is broader than its evidence. (LLM, conf=0.87)
Experimental — accuracy not yet measuredThe reduced fracture risk with pharmacologic therapy in patients with spine and hip fractures is true for fracture patients with BMD in both the low bone mass and osteoporosis range.
“This is true for fracture patients with BMD in both the low bone mass and osteoporosis range [49–58].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [58]
The Fractures section reports fewer new clinical fractures with zoledronic acid than with placebo after hip-fracture repair. The Results section says 41.8% of participants had a femoral-neck T score below −2.5, but the paper does not report fracture-risk reductions separately for low-bone-mass and osteoporosis BMD ranges. Its trial enrolled patients after hip fracture, not a separate group of patients with spine fractures. (LLM, conf=0.86)
Experimental — accuracy not yet measuredZoledronic acid is indicated for the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture.
“Zoledronic acid is also indicated for the prevention of new clinical fractures in patients (both women and men) who have recently had a low-trauma (osteoporosis-related) hip fracture [58].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [58]
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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
- 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
- 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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