Evidence map›Paper›PMID 23605142›Full record

SynthesisInternational journal of clinical oncology2014

Risk of osteonecrosis of the jaw in cancer patients receiving denosumab: a meta-analysis of seven randomized controlled trials.

Wei-Xiang Qi, Li-Na Tang, Ai-Na He, Yang Yao, Zan Shen

Registry-linked trialAbstract readMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in International journal of clinical oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04257721 (Development Of A Predictive Score For Maxillary Osteochimionecrosis After Invasive Oral Surgery In Patients Treated Whith Biphosphonates Or Biotherapies), which is not on this map. Cited by 80 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

NCT04257721 terminatednot on this mapstarted 2019, after this paper: background citation

Development Of A Predictive Score For Maxillary Osteochimionecrosis After Invasive Oral Surgery In Patients Treated Whith Biphosphonates Or Biotherapies: The PREV-ONM Study

TypeobservationalSponsorCentre Hospitalier Sud FrancilienRan2019 to 2022Enrolled45ConditionsOsteonecrosis Due to Drugs, Jaw
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Interventions for managing medication-related osteonecrosis of the jaw.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Prevalence of medication related osteonecrosis of the jaw in patients treated with sequential antiresorptive drugs: systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
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  6. Interventions for managing medication-related osteonecrosis of the jaw.The Cochrane database of systematic reviews · 2017
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  13. [Expert consensus on perioperative management of tooth extraction in patients receiving denosumab therapy].Hua xi kou qiang yi xue za zhi = Huaxi kouqiang yixue zazhi = West China journal of stomatology · 2026
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20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Wei-Xiang QiDepartment of Oncology, The Sixth People's Hospital, Shanghai Jiao Tong University, No. 600, Yishan Road, Shanghai, 200233, China.
Li-Na Tang
Ai-Na He
Yang Yao
Zan Shen

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe aim of this study is to gain a better understanding of the overall incidence and risk of osteonecrosis of the jaw (ONJ) in cancer patients receiving denosumab.

methodsWe performed a meta-analysis of relevant randomized controlled trials identified in Pubmed, Embase, and Cochrane databases. Abstracts presented at the conferences were also searched. Overall incidence rates, relative risk (RR), and 95 % confidence intervals (CI) were calculated employing fixed- or random-effects models depending on the heterogeneity of the included trials.

resultsA total of 8963 patients with a variety of solid tumors from 7 randomized controlled trials (RCTs) were included for the meta-analysis. The overall incidence of ONJ in cancer patients receiving denosumab was 1.7 % [95 % CI: 0.9-3.1 %]. Also, the use of denosumab was associated with significantly increased risk of ONJ in comparison with bisphosphonates (BPs)/placebo treatment (RR 1.61, 95 % CI: 1.05-2.48, P = 0.029). Subgroup analysis based on controlled therapies demonstrated an increased risk of ONJ in denosumab therapy, when compared with BPs (RR 1.48, 95 % CI: 0.96-2.29, P = 0.078) or placebo (RR 16.28, 95 % CI: 1.68-158.05, P = 0.017). Similar results were observed in prostate cancer (RR 3.358, 95 % CI: 1.573-7.166, P = 0.002) while there was a non-significantly increased risk of denosumab-related osteonecrosis of the jaw (DONJ) in non-prostate cancers (RR 1.142, 95 % CI: 0.678-1.921, P = 0.618).

conclusionsThe use of denosumab is associated with an increased risk of developing ONJ when compared with BP treatment or placebo, although the increased risk was not statistically significant between denosumab and BP treatment. Further studies are still needed to establish guidelines for the prevention and effective treatment of ONJ.

Indexed as

Antibodies, Monoclonal, HumanizedDenosumabFemaleHumansJaw DiseasesMaleNeoplasmsOsteonecrosisProstatic NeoplasmsPublication BiasRandomized Controlled Trials as TopicRANK LigandRiskAntibodies, Monoclonal, HumanizedDenosumabRANK Ligand

Identifiers

PMID23605142

What OpenQuestion holds

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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.