Fracture risk and zoledronic acid therapy in men with osteoporosis

Steven Boonen, Jean Yves Reginster, Jean Marc Kaufman, Kurt Lippuner, Jose Zanchetta, Bente Langdahl, Rene Rizzoli, Stanley Lipschitz, Hans Peter Dimai, Richard Witvrouw, Erik Eriksen, Kim Brixen, Luis Russo, Frank Claessens, Philemon Papanastasiou, Oscar Antunez, Guoqin Su, Christina Bucci-Rechtweg, Josef Hruska, Elodie InceraDirk Vanderschueren, Eric Orwoll

Research output: Contribution to journalArticle

172 Citations (Scopus)

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

Original languageEnglish (US)
Pages (from-to)1714-1723
Number of pages10
JournalNew England Journal of Medicine
Volume367
Issue number18
DOIs
StatePublished - Nov 1 2012

Fingerprint

zoledronic acid
Osteoporosis
Placebos
Therapeutics
Hypogonadism
Bone Remodeling
Risk Reduction Behavior
Intravenous Infusions
Vitamin D
Bone Density

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Boonen, S., Reginster, J. Y., Kaufman, J. M., Lippuner, K., Zanchetta, J., Langdahl, B., ... Orwoll, E. (2012). Fracture risk and zoledronic acid therapy in men with osteoporosis. New England Journal of Medicine, 367(18), 1714-1723. https://doi.org/10.1056/NEJMoa1204061

Fracture risk and zoledronic acid therapy in men with osteoporosis. / 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.

In: New England Journal of Medicine, Vol. 367, No. 18, 01.11.2012, p. 1714-1723.

Research output: Contribution to journalArticle

Boonen, S, Reginster, JY, Kaufman, JM, Lippuner, K, Zanchetta, J, Langdahl, B, Rizzoli, R, Lipschitz, S, Dimai, HP, 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 2012, 'Fracture risk and zoledronic acid therapy in men with osteoporosis', New England Journal of Medicine, vol. 367, no. 18, pp. 1714-1723. https://doi.org/10.1056/NEJMoa1204061
Boonen S, Reginster JY, Kaufman JM, Lippuner K, Zanchetta J, Langdahl B et al. Fracture risk and zoledronic acid therapy in men with osteoporosis. New England Journal of Medicine. 2012 Nov 1;367(18):1714-1723. https://doi.org/10.1056/NEJMoa1204061
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. / Fracture risk and zoledronic acid therapy in men with osteoporosis. In: New England Journal of Medicine. 2012 ; Vol. 367, No. 18. pp. 1714-1723.
@article{0b1ac9436db04f27a926b422b6358558,
title = "Fracture risk and zoledronic acid therapy in men with osteoporosis",
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",
author = "Steven Boonen and Reginster, {Jean Yves} and Kaufman, {Jean Marc} and Kurt Lippuner and Jose Zanchetta and Bente Langdahl and Rene Rizzoli and Stanley Lipschitz and Dimai, {Hans Peter} and Richard Witvrouw and Erik Eriksen and Kim Brixen and Luis Russo and Frank Claessens and Philemon Papanastasiou and Oscar Antunez and Guoqin Su and Christina Bucci-Rechtweg and Josef Hruska and Elodie Incera and Dirk Vanderschueren and Eric Orwoll",
year = "2012",
month = "11",
day = "1",
doi = "10.1056/NEJMoa1204061",
language = "English (US)",
volume = "367",
pages = "1714--1723",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "18",

}

TY - JOUR

T1 - Fracture risk and zoledronic acid therapy in men with osteoporosis

AU - Boonen, Steven

AU - Reginster, Jean Yves

AU - Kaufman, Jean Marc

AU - Lippuner, Kurt

AU - Zanchetta, Jose

AU - Langdahl, Bente

AU - Rizzoli, Rene

AU - Lipschitz, Stanley

AU - Dimai, Hans Peter

AU - Witvrouw, Richard

AU - Eriksen, Erik

AU - Brixen, Kim

AU - Russo, Luis

AU - Claessens, Frank

AU - Papanastasiou, Philemon

AU - Antunez, Oscar

AU - Su, Guoqin

AU - Bucci-Rechtweg, Christina

AU - Hruska, Josef

AU - Incera, Elodie

AU - Vanderschueren, Dirk

AU - Orwoll, Eric

PY - 2012/11/1

Y1 - 2012/11/1

N2 - 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

AB - 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

UR - http://www.scopus.com/inward/record.url?scp=84868258081&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84868258081&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1204061

DO - 10.1056/NEJMoa1204061

M3 - Article

C2 - 23113482

AN - SCOPUS:84868258081

VL - 367

SP - 1714

EP - 1723

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 18

ER -