Evidence map›Paper›PMID 33023785›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2021

A randomised trial of 4- versus 12-weekly administration of bone-targeted agents in patients with bone metastases from breast or castration-resistant prostate cancer.

Mark Clemons, Michael Ong, Carol Stober, Scott Ernst, Christopher Booth, Christina Canil, Mihaela Mates, Andrew Robinson, Phillip Blanchette, Anil Abraham Joy and 10 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 5% 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.

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

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 67 citations in OpenAlex.

  1. Long-term impact of bone-modifying agents for the treatment of bone metastases: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Pooled it
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  3. Symptomatic skeletal-related events in patients receiving longer term bone-modifying agents for bone metastases from breast and castration resistant prostate cancers.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
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  15. Bone health in cancer: perspective on the use of osteoanabolic agents.Therapeutic advances in endocrinology and metabolism · 2025
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 7 institutions in 1 country.

Mark ClemonsDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada. Electronic address: mclemons@toh.ca.
Michael OngDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada.
Carol StoberCancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
Scott ErnstDivision of Medical Oncology, Department of Oncology, London Regional Cancer Program, London Health Sciences Centre and University of Western Ontario, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.
Christopher BoothCancer Centre of Southeastern Ontario, 25 King Street West, Kingston, Ontario, K7L 5P9, Canada.
Christina CanilDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada.
Mihaela MatesCancer Centre of Southeastern Ontario, 25 King Street West, Kingston, Ontario, K7L 5P9, Canada.
Andrew RobinsonCancer Centre of Southeastern Ontario, 25 King Street West, Kingston, Ontario, K7L 5P9, Canada.
Phillip BlanchetteDivision of Medical Oncology, Department of Oncology, London Regional Cancer Program, London Health Sciences Centre and University of Western Ontario, 800 Commissioners Road East, London, Ontario, N6A 5W9, Canada.
Anil Abraham JoyDivision of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, 11560 University Avenue, Edmonton, Alberta, T6G 1Z2, Canada.
John HiltonDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
Olexiy AseyevRegional Cancer Care Northwest, Thunder Bay Regional Health Sciences Centre, 980 Oliver Road, Thunder Bay, Ontario, P7B 6V4, Canada.
Gregory PondDepartment of Oncology, McMaster University, 699 Concession Street, Suite 4-204, Hamilton, Ontario, L8V 5C2, Canada.
Ahwon JeongCancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
Brian HuttonClinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
Sasha MazzarelloCancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
Lisa VandermeerCancer Therapeutics Program, Ottawa Hospital Research Institute, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
Igal KushnirDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, 501 Smyth Road, Box 912, Ottawa, Ontario, K1H 8L6, Canada.
Dean FergussonClinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, 501 Smyth Road, Box 511, Ottawa, Ontario, K1H 8L6, Canada.
REaCT investigators
University of Ottawa · CAOttawa Hospital · CACancer Care South East · CAWestern University · CAMcMaster University · CAThunder Bay Regional Health Sciences Centre · CAUniversity of Alberta · CA

Funding

Canadian Institute of Health Research
6 · The paper itself

Abstract

backgroundOptimal dosing of bone-targeted agents (BTAs), in patients with bone metastases remains an important clinical question. This trial compared 4-weekly versus 12-weekly therapy. PATIENTS AND

methodsPatients with bone metastases from breast or castration-resistant prostate cancer (CRPC), who were going to start or already on BTAs, were randomised 1:1 to 4-weekly or 12-weekly BTA treatment for one year. Primary end point was change in health-related quality of life (HRQoL)-physical function European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30). Secondary end points included pain (EORTC-QLQ-BM22), global health status (EORTC-QLQ-C30), symptomatic skeletal events (SSEs) rates and time to SSEs. Primary analysis was per protocol and a non-inferiority margin of 5 points was used.

resultsOf 263 patients (160 breast cancer, 103 CRPC), 133 (50.6%) and 130 (49.4%) were randomised to the 4- and 12-weekly groups, respectively. BTAs included denosumab (56.3%), zoledronate (24.0%) and pamidronate (19.8%). Using repeated-measures analysis, across all time points, patients in the 4-weekly arm had a mean HRQL-physical subdomain score which was 1.2 (95% confidence interval: -1.6 to 4.0) higher than the 12-weekly arm. The study met the definition of non-inferiority for our primary outcome. Secondary outcomes showed no significant difference in scores for pain, global health status, SSE rates and SSE-free survival between arms. Subgroup analyses for cancer type, prior BTA use or BTA type showed no significant difference between arms.

conclusionThese results in addition to those previously reported for de-escalating zoledronate and systematic reviews in both breast and prostate cancers, would support that de-escalation of commonly used BTAs is a reasonable treatment option.

Indexed as

AgedBone Density Conservation AgentsBone NeoplasmsBreast NeoplasmsDrug Administration ScheduleFemaleHumansMaleMiddle AgedProstatic Neoplasms, Castration-ResistantBone Density Conservation Agentsbone metastasisbreast cancerdenosumabpamidronateprostate cancerzoledronate

Identifiers

PMID33023785
PMCPMC7532126
OpenAlexW3091531967

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.