Evidence map›Paper›PMID 31218477›Full record

Trial reportBreast cancer research and treatment2019

Randomized controlled trial of high-dose versus standard-dose vitamin D3 for prevention of aromatase inhibitor-induced arthralgia.

Polly Niravath, Susan G Hilsenbeck, Tao Wang, Sao Jiralerspong, Julie Nangia, Anne Pavlick, Foluso Ademuyiwa, Ashley Frith, Cynthia Ma, Haeseong Park and 5 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
1.6field-weighted citation impact, top 15% 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

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 19 citations in OpenAlex.

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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

15 authors at 2 institutions in 1 country.

Polly NiravathBaylor College of Medicine, 6445 Main Street, OPC 24-346, Houston, TX, 77030, USA. paniravath@houstonmethodist.org.ORCID http://orcid.org/0000-0003-0530-8883
Susan G HilsenbeckBaylor College of Medicine, 6445 Main Street, OPC 24-346, Houston, TX, 77030, USA.
Tao WangBaylor College of Medicine, 6445 Main Street, OPC 24-346, Houston, TX, 77030, USA.
Sao JiralerspongBaylor College of Medicine, 6445 Main Street, OPC 24-346, Houston, TX, 77030, USA.
Julie NangiaBaylor College of Medicine, 6445 Main Street, OPC 24-346, Houston, TX, 77030, USA.
Anne PavlickBaylor College of Medicine, 6445 Main Street, OPC 24-346, Houston, TX, 77030, USA.
Foluso AdemuyiwaWashington University, St. Louis, MO, USA.
Ashley FrithWashington University, St. Louis, MO, USA.
Cynthia MaWashington University, St. Louis, MO, USA.
Haeseong ParkWashington University, St. Louis, MO, USA.
Caron RigdenWashington University, St. Louis, MO, USA.
Rama SureshWashington University, St. Louis, MO, USA.
Matthew EllisBaylor College of Medicine, 6445 Main Street, OPC 24-346, Houston, TX, 77030, USA.
C Kent OsborneBaylor College of Medicine, 6445 Main Street, OPC 24-346, Houston, TX, 77030, USA.
Mothaffar F RimawiBaylor College of Medicine, 6445 Main Street, OPC 24-346, Houston, TX, 77030, USA.
Baylor College of Medicine · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeHalf of hormone receptor-positive (HR+) breast cancer patients will develop joint pain, termed aromatase inhibitor-induced arthralgia (AIA), while taking aromatase inhibitor therapy. Though there is no universally accepted effective treatment for AIA, there has been some evidence to support high-dose vitamin D as a treatment.

methodsWe randomized post-menopausal women who were beginning adjuvant AI therapy to receive standard-dose vitamin D3 (800 IU daily for 52 weeks), or high-dose vitamin D3 (50,000 IU weekly for 12 weeks, followed by 2000 IU daily for 40 weeks). The primary end point was development of AIA. The trial was designed to enroll 184 patients. This futility analysis was performed after 93 patients were enrolled.

resultsThe high-dose vitamin D regimen was effective in raising serum vitamin D levels, but there was no significant difference in development of AIA between the two arms. In the high-dose arm, 25 patients (54%) developed AIA, compared to 27 patients (57%) in the standard-dose arm. The planned futility analysis was positive; thus, the study was terminated. Neither baseline vitamin D nor 12-week vitamin D level was predictive of AIA development.

conclusionAlthough vitamin D levels were increased in the high-dose arm, there was no significant signal for benefit of high-dose vitamin D supplementation for AIA prevention in this unblinded trial. This study, along with several others, implies that vitamin D likely does not play a significant role in AIA for the majority of patients.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, HormonalAromatase InhibitorsArthralgiaBreast NeoplasmsCholecalciferolDietary SupplementsFemaleHumansMedication AdherenceMiddle AgedNeoplasm StagingRisk FactorsTreatment OutcomeAntineoplastic Agents, HormonalAromatase InhibitorsCholecalciferolAromatase inhibitor-induced arthralgiaCancer survivorshipMedication complianceVitamin D

Identifiers

PMID31218477
OpenAlexW2952761577

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.