Cited by 379Bone health and osteoporosis researchBone health and treatmentsBone Metabolism and Diseases

Fracture risk and zoledronic acid therapy in men with osteoporosis

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Boonen, Steven, Reginster, Jean-Yves, Kaufman, Jean-Marc, Lippuner, Kurt, Zanchetta, Jose, Langdahl, Bente, Rizzoli, Rene, Lipschitz, Stanley +14 more·2012·New England Journal of Medicine

Abstract

BACKGROUND: Fractures in men are a major health issue, and data on the antifracture efficacy of therapies for osteoporosis in men are limited. We studied the effect of zoledronic acid on fracture risk among men with osteoporosis. METHODS: In this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1199 men with primary or hypogonadism-associated osteoporosis who were 50 to 85 years of age to receive an intravenous infusion of zoledronic acid (5 mg) or placebo at baseline and at 12 months. Participants received daily calcium and vitamin D supplementation. The primary end point was the proportion of participants with one or more new morphometric vertebral fractures over a period of 24 months. RESULTS: The rate of any new morphometric vertebral fracture was 1.6% in the zoledronic acid group and 4.9% in the placebo group over the 24-month period, representing a 67% risk reduction with zoledronic acid (relative risk, 0.33; 95% confidence interval, 0.16 to 0.70; P=0.002). As compared with men who received placebo, men who received zoledronic acid had fewer moderate-to-severe vertebral fractures (P=0.03) and less height loss (P=0.002). Fewer participants who received zoledronic acid had clinical vertebral or nonvertebral fractures, although this difference did not reach significance because of the small number of fractures. Bone mineral density was higher and bone-turnover markers were lower in the men who received zoledronic acid (P<0.05 for both comparisons). Results were similar in men with low serum levels of total testosterone. The zoledronic acid and placebo groups did not differ significantly with respect to the incidence of death (2.6% and 2.9%, respectively) or serious adverse events (25.3% and 25.2%). CONCLUSIONS: Zoledronic acid treatment was associated with a significantly reduced risk of vertebral fracture among men with osteoporosis. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT00439647.).

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Authors
Boonen, S., Reginster, J.-Y., Kaufman, J.-M., Lippuner, K., Zanchetta, J., Langdahl, B., Rizzoli, R., Lipschitz, S., Dimai, H. P., Witvrouw, R., Eriksen, E., Brixen, K., Russo, L., Claessens, F., Papanastasiou, P., Antunez, O., Su, G., Bucci-Rechtweg, C., Hruska, J., Incera, E., Vanderschueren, D., & Orwoll, E.
Affiliations
  • KU Leuven (BE)
  • University of Liège (BE)
  • Ghent University (BE)
  • University of Bern (CH)
  • Aarhus University Hospital (DK)
  • Medical University of Graz (AT)
  • Ziekenhuis Oost-Limburg (BE)
  • University of Oslo (NO)
  • University of Southern Denmark (DK)
  • Novartis (Switzerland) (CH)
  • Oregon Health & Science University (US)
Venue
New England Journal of Medicine
Published
2012-11
Volume
367
Issue
18
Pages
1714-1723
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2123816368
Cited by
359
References
30
Citations by year
2026: 17 · 2025: 24 · 2024: 23 · 2023: 21 · 2022: 25 · 2021: 25 · 2020: 26 · 2019: 24 · 2018: 30 · 2017: 21 · 2016: 28 · 2015: 23 · 2014: 29 · 2013: 36 · 2012: 5
FWCI
32.02
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Archive ouverte UNIGE (University of Geneva) (publishedVersion)
  • Ghent University Academic Bibliography (Ghent University) (submittedVersion)
  • BORIS (University Library Bern) (submittedVersion, other-oa)
  • IRIS (submittedVersion)
  • Open Repository and Bibliography (University of Liège) (submittedVersion)
  • University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
  • SERVAL (Université de Lausanne) (submittedVersion)
  • Archive ouverte UNIGE (University of Geneva) (submittedVersion, cc-by)
  • Open Access CRIS of the University of Bern
Funders
  • U.S. Department of Justice
  • Amgen
  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • Pfizer
  • GlaxoSmithKline
  • Teva Pharmaceutical Industries
  • Danone
  • University of Bern
  • Union Chimique Belge
  • Daiichi-Sankyo
  • Novo Nordisk
  • Servier
Topics
  • Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
  • Health Sciences › Medicine › Oncology › Bone health and treatments
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Bone Metabolism and Diseases
Keywords
zoledronic acid, male osteoporosis, vertebral fractures, fracture risk reduction, bisphosphonates, androgen deficiency, bone mineral density, bone turnover markers, height loss
MeSH terms
Zoledronic Acid, Aged, Aged, 80 and over, Analysis of Variance, Diphosphonates, Double-Blind Method, Humans, Hypogonadism, Imidazoles, Male, Middle Aged, Osteoporosis, Risk, Testosterone, Bone Density, Logistic Models, Spinal Fractures, Bone Density Conservation Agents

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