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

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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, Dimai, Hans Peter, Witvrouw, Richard, Eriksen, Erik, Brixen, Kim, Russo, Luis, Claessens, Frank, Papanastasiou, Philemon, Antunez, Oscar, Su, Guoqin, Bucci-Rechtweg, Christina, Hruska, Josef, Incera, Elodie, Vanderschueren, Dirk, Orwoll, Eric·2012·New England Journal of Medicine

DOI 10.1056/nejmoa1204061

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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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Additional file 2 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
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Additional file 14 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
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Additional file 3 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
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Additional file 13 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
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Additional file 10 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
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Additional file 18 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
Zheng, X., Ye, J., Zhan, Q., Zhao, W., Liao, Z., Ye, X., & Qu, C. (2024) · Figshare · doi:10.6084/m9.figshare.26631805
Additional file 17 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
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Additional file 11 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
Zheng, X., Ye, J., Zhan, Q., Zhao, W., Liao, Z., Ye, X., & Qu, C. (2024) · Figshare · doi:10.6084/m9.figshare.26631784
Additional file 7 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
Zheng, X., Ye, J., Zhan, Q., Zhao, W., Liao, Z., Ye, X., & Qu, C. (2024) · Figshare · doi:10.6084/m9.figshare.26631772
Additional file 9 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
Zheng, X., Ye, J., Zhan, Q., Zhao, W., Liao, Z., Ye, X., & Qu, C. (2024) · Figshare · doi:10.6084/m9.figshare.26631778
Additional file 6 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
Zheng, X., Ye, J., Zhan, Q., Zhao, W., Liao, Z., Ye, X., & Qu, C. (2024) · Figshare · doi:10.6084/m9.figshare.26631769
Additional file 16 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
Zheng, X., Ye, J., Zhan, Q., Zhao, W., Liao, Z., Ye, X., & Qu, C. (2024) · Figshare · doi:10.6084/m9.figshare.26631799
Additional file 4 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
Zheng, X., Ye, J., Zhan, Q., Zhao, W., Liao, Z., Ye, X., & Qu, C. (2024) · Figshare · doi:10.6084/m9.figshare.26631763
Additional file 12 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
Zheng, X., Ye, J., Zhan, Q., Zhao, W., Liao, Z., Ye, X., & Qu, C. (2024) · Figshare · doi:10.6084/m9.figshare.26631787
Additional file 20 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
Zheng, X., Ye, J., Zhan, Q., Zhao, W., Liao, Z., Ye, X., & Qu, C. (2024) · Figshare · doi:10.6084/m9.figshare.26631811
Additional file 5 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
Zheng, X., Ye, J., Zhan, Q., Zhao, W., Liao, Z., Ye, X., & Qu, C. (2024) · Figshare · doi:10.6084/m9.figshare.26631766
Additional file 15 of Prediction of musculoskeletal pain after the first intravenous zoledronic acid injection in patients with primary osteoporosis: development and evaluation of a new nomogram
Zheng, X., Ye, J., Zhan, Q., Zhao, W., Liao, Z., Ye, X., & Qu, C. (2024) · Figshare · doi:10.6084/m9.figshare.26631796
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Takigawa, M., Kotake, K., Tsuge, T., Saitsu, A., Isaji, Y., Kondo, S., Maruyama, T., & Yamamoto, N. (2026) · Journal of Bone and Mineral Metabolism · doi:10.1007/s00774-026-01751-x
The Weight-Adjusted Waist Index as a Screening Indicator for Obesity-Related Bone Loss in American Men Aged 18-59: Evidence From the National Health and Nutrition Examination Survey
Long, Y., Qin, L., Long, H., She, R., & Long, S. (2026) · American Journal of Men s Health · doi:10.1177/15579883261495666

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)
ORCID: Reginster, Jean-Yves
Kaufman, Jean-Marc
Lippuner, Kurt
Langdahl, Bente
Dimai, Hans Peter
Eriksen, Erik
Claessens, Frank
Bucci-Rechtweg, Christina
Incera, Elodie
Vanderschueren, Dirk
Orwoll, Eric
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2012-11
Volume: 367
Issue: 18
Pages: 1714-1723
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1204061
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: bronze
doi.org
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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Fracture Risk and Zoledronic Acid Therapy in Men with Osteoporosis

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