Evidence map›Paper›PMID 17476007›Full record

Trial reportThe New England journal of medicine2007

Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis.

Dennis M Black, Pierre D Delmas, Richard Eastell, Ian R Reid, Steven Boonen, Jane A Cauley, Felicia Cosman, Péter Lakatos, Ping Chung Leung, Zulema Man and 12 more

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

Trial report in The New England journal of medicine, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 1,013 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,013citing papers in PubMed, 18 pooled it
183.1field-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.

NCT00049829 phase3completednot on this map

HORIZON-PFT: Pivotal Fracture Trial

TypeinterventionalSponsorNovartis PharmaceuticalsRan2002Enrolled7,700ConditionsOsteoporosisArmsZoledronic Acid
NCT01197300 phase3completednot on this mapstarted 2010, after this paper: background citation

A 1-year, Multicenter, Open-label Extension to CZOL446H2337 to Evaluate Safety and Efficacy of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids

TypeinterventionalSponsorNovartis PharmaceuticalsRan2010 to 2019Enrolled25ConditionsOsteoporosisArmsZoledronic acid
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
NCT06135298 phase4completednot on this mapstarted 2023, after this paper: background citation

Augmentation of Pertrochanteric Fracture Proximal Femoral Nail Osteosynthesis Using Calcium Sulphate/Hydroxyapatite Combined With Systemic Bisphosphonate - A Pilot Study of the FARE (Fracture Anchorage and Bone REgeneration) Method

TypeinterventionalSponsorAksaray UniversityRan2023 to 2026Enrolled20ConditionsTrochanteric Fracture of Femur, Osteoporotic Fracture of Femur, Hip Fractures, Bone Density, LowArmsOSTEOSYNTHESIS, Zoledronic acid, CERAMENT BONE VOID FILLER (BVF)
NCT06414616 completednot on this mapstarted 2022, after this paper: background citation

Are We Overly Concerned About Rebound Fractures? Real-World Evidence of Adherence to Denosumab Therapy and Fracture Risk Associated With Drug Withdrawal: A Cross-sectional Study

TypeobservationalSponsorTrakya UniversityRan2022 to 2024Enrolled210ConditionsOsteoporosis
3 · Its place in the literature

Who cites it

1,013 citing papers in PubMed, 18 syntheses or guidelines pooled it, 2,925 citations in OpenAlex.

  1. Guideline
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  12. Denosumab vs. bisphosphonates in primary osteoporosis: a meta-analysis of comparative safety in 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 · 2024
    Pooled it
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  15. The correlation between osteoporotic vertebrae fracture risk and bone mineral density measured by quantitative computed tomography and dual energy X-ray absorptiometry: a systematic review and meta-analysis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2023
    Pooled it
  16. Association between bisphosphonate use and stroke risk: a meta-analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023
    Pooled it
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  19. Decreased nonvertebral fracture incidence with zoledronate use for >3 years: post hoc analysis of a Randomized Controlled Trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2026
    Trial
  20. Trial

953 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 11 institutions in 8 countries.

Dennis M BlackUniversity of California, San Francisco, San Francisco, CA 94107, USA. dblack@psg.ucsf.edu
Pierre D Delmas
Richard Eastell
Ian R Reid
Steven Boonen
Jane A Cauley
Felicia Cosman
Péter Lakatos
Ping Chung Leung
Zulema Man
Carlos Mautalen
Peter Mesenbrink
Huilin Hu
John Caminis
Karen Tong
Theresa Rosario-Jansen
Joel Krasnow
Trisha F Hue
Deborah Sellmeyer
Erik Fink Eriksen
Steven R Cummings
HORIZON Pivotal Fracture Trial
University of California, San Francisco · USChinese University of Hong Kong · CNHelen Hayes Hospital · USKU Leuven · BENovartis (Switzerland) · CHSemmelweis University · HUThe Coordinating Center · USUniversité Claude Bernard Lyon 1 · FRUniversity of Auckland · NZUniversity of Pittsburgh · USUniversity of Sheffield · GB

Funding

University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
NCATS NIH HHS UL1 TR000005
6 · The paper itself

Abstract

backgroundA single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis. We assessed the effects of annual infusions of zoledronic acid on fracture risk during a 3-year period.

methodsIn this double-blind, placebo-controlled trial, 3889 patients (mean age, 73 years) were randomly assigned to receive a single 15-minute infusion of zoledronic acid (5 mg) and 3876 were assigned to receive placebo at baseline, at 12 months, and at 24 months; the patients were followed until 36 months. Primary end points were new vertebral fracture (in patients not taking concomitant osteoporosis medications) and hip fracture (in all patients). Secondary end points included bone mineral density, bone turnover markers, and safety outcomes.

resultsTreatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo (3.3% in the zoledronic-acid group vs. 10.9% in the placebo group; relative risk, 0.30; 95% confidence interval [CI], 0.24 to 0.38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic-acid group vs. 2.5% in the placebo group; hazard ratio, 0.59; 95% CI, 0.42 to 0.83). Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33%, and 77%, respectively (P<0.001 for all comparisons). Zoledronic acid was also associated with a significant improvement in bone mineral density and bone metabolism markers. Adverse events, including change in renal function, were similar in the two study groups. However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 vs. 20 patients, P<0.001).

conclusionsA once-yearly infusion of zoledronic acid during a 3-year period significantly reduced the risk of vertebral, hip, and other fractures. (ClinicalTrials.gov number, NCT00049829.)

Indexed as

AgedAged, 80 and overAtrial FibrillationBiomarkersBone DensityBone Density Conservation AgentsDiphosphonatesDouble-Blind MethodDrug Administration ScheduleFemaleFractures, BoneHip FracturesHumansImidazolesIncidenceInfusions, IntravenousBiomarkersBone Density Conservation AgentsDiphosphonatesImidazolesZoledronic Acid

Identifiers

PMID17476007
OpenAlexW1993035292

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.