Evidence map›Paper›PMID 23814519›Full record

ArticleJournal of oncology practice2013

Acute kidney injury and bisphosphonate use in cancer: a report from the research on adverse drug events and reports (RADAR) project.

Beatrice J Edwards, Sarah Usmani, Dennis W Raisch, June M McKoy, Athena T Samaras, Steven M Belknap, Steven M Trifilio, Allison Hahr, Andrew D Bunta, Ali Abu-Alfa and 3 more

Abstract read
In one paragraph

Article in Journal of oncology practice, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Renal safety of zoledronic acid for osteoporosis in adults 75 years and older.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2022
    Article
  6. Review
  7. Bisphosphonate nephropathy: A case series and review of the literature.British journal of clinical pharmacology · 2021
    Review
  8. Article
  9. Fractures frequently occur in older cancer patients: the MD Anderson Cancer Center experience.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018
    Article
  10. Review
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

13 authors.

Beatrice J EdwardsNorthwestern University Feinberg School of Medicine, Chicago, IL 60611, USA. Bje168@northwestern.edu
Sarah Usmani
Dennis W Raisch
June M McKoy
Athena T Samaras
Steven M Belknap
Steven M Trifilio
Allison Hahr
Andrew D Bunta
Ali Abu-Alfa
Craig B Langman
Steve T Rosen
Dennis P West

Funding

Multidisciplinary Clinical and Translational Science (MCTS) Program (UL1)UL1TR000150 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LLOYD-JONES, DONALD M · 2012 to 2013
$10.1M
Research on Adverse Drug Events and Reports: Novel Multiple Myeloma DrugsR01CA125077 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI BENNETT, CHARLES L. · 2007 to 2009
$1.7M
Adverse Drug Reactions in Geriatric Cancer PatientsK01CA134554 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI MCKOY, JUNE M. · 2008 to 2012
$737k
NCATS NIH HHS UL1 TR000150NCI NIH HHS 1 K01 CA134554-01NCI NIH HHS 3R01 CA125077-03S1NCI NIH HHS 5R01 CA125077-03NCI NIH HHS K01 CA134554NCI NIH HHS R01 CA125077
6 · The paper itself

Abstract

purposeTo determine whether acute kidney injury (AKI) is identified within the US Food and Drug Administration's Adverse Events and Reporting System (FDA AERS) as an adverse event resulting from bisphosphonate (BP) use in cancer therapy.

methodsA search of the FDA AERS records from January 1998 through June 2009 was performed; search terms were "renal problems" and all drug names for BPs. The search resulted in 2,091 reports. We analyzed for signals of disproportional association by calculating the proportional reporting ratio for zoledronic acid (ZOL) and pamidronate. Literature review of BP-associated renal injury within the cancer setting was conducted.

resultsFour hundred eighty cases of BP-associated acute kidney injury (AKI) were identified in patients with cancer. Two hundred ninety-eight patients (56%) were female; mean age was 66 ± 10 years. Multiple myeloma (n = 220, 46%), breast cancer (n = 98, 20%), and prostate cancer (n = 24, 5%) were identified. Agents included ZOL (n = 411, 87.5%), pamidronate (n = 8, 17%), and alendronate (n = 36, 2%). Outcomes included hospitalization (n = 304, 63.3%) and death (n = 68, 14%). The proportional reporting ratio for ZOL was 1.22 (95% CI, 1.13 to 1.32) and for pamidronate was 1.55 (95% CI, 1.25 to 1.65), reflecting a nonsignificant safety signal for both drugs.

conclusionAKI was identified in BP cancer clinical trials, although a safety signal for BPs and AKI within the FDA AERS was not detected. Our findings may be attributed, in part, to clinicians who believe that AKI occurs infrequently; ascribe the AKI to underlying premorbid disease, therapy, or cancer progression; or consider that AKI is a known adverse drug reaction of BPs and thus under-report AKI to the AERS.

Indexed as

Acute Kidney InjuryAdverse Drug Reaction Reporting SystemsAgedBone Density Conservation AgentsDiphosphonatesFemaleHumansMaleMiddle AgedNeoplasmsBone Density Conservation AgentsDiphosphonates

Identifiers

PMID23814519
PMCPMC3595436

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.