Evidence map›Paper›PMID 23113482›Full record

Trial reportThe New England journal of medicine2012

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 and 12 more

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 145 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
145citing papers in PubMed, 21 pooled it
24.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00439647 phase3completednot on this map

A Two Year Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Fracture Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Annually for the Treatment of Osteoporosis in Men

TypeinterventionalSponsorNovartis PharmaceuticalsRan2006 to 2010Enrolled1,199ConditionsMale OsteoporosisArmsZoledronic acid 5 mg iv, Placebo
NCT04742010 phase2completednot on this mapstarted 2021, after this paper: background citation

Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)

TypeinterventionalSponsorStinus Gadegaard HansenRan2021 to 2024Enrolled59ConditionsBone Loss, Muscle Atrophy, Bariatric SurgeryArmsZoledronic Acid, Placebo
3 · Its place in the literature

Who cites it

145 citing papers in PubMed, 21 syntheses or guidelines pooled it, 350 citations in OpenAlex.

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  10. Association between total and animal proteins with risk of fracture: A systematic review and dose-response meta-analysis of cohort studies.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024
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  20. Efficacy of bisphosphonates against osteoporosis in adult men: a meta-analysis of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015
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85 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 13 institutions in 7 countries.

Steven BoonenKatholieke Universiteit Leuven, Leuven, Belgium. en.boonen@uz.kuleuven.ac.be
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 Incera
Dirk Vanderschueren
Eric Orwoll
KU Leuven · BENovartis (Switzerland) · CHAarhus University Hospital · DKGeneva College · USGhent University Hospital · BEMedical University of Graz · ATOregon Health & Science University · USUniversidad del Salvador · ARUniversity of Bern · CHUniversity of Liège · BEUniversity of Oslo · NOUniversity of Southern Denmark · DKZiekenhuis Oost-Limburg · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFractures 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.

methodsIn 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.

resultsThe 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%).

conclusionsZoledronic acid treatment was associated with a significantly reduced risk of vertebral fracture among men with osteoporosis. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT00439647.).

Indexed as

AgedAged, 80 and overAnalysis of VarianceBone DensityBone Density Conservation AgentsDiphosphonatesDouble-Blind MethodHumansHypogonadismImidazolesLogistic ModelsMaleMiddle AgedOsteoporosisRiskSpinal FracturesBone Density Conservation AgentsDiphosphonatesImidazolesTestosteroneZoledronic Acid

Identifiers

PMID23113482
OpenAlexW2123816368

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.