Evidence map›Paper›PMID 32226828›Full record

ArticleOsteoporosis and sarcopenia2020

Association between elcatonin use and cancer risk in Japan: A follow-up study after a randomized, double-blind, placebo-controlled study of once-weekly elcatonin in primary postmenopausal osteoporosis.

Hiroaki Okamoto, Nayumi Shibazaki, Takeshi Yoshimura, Toyonobu Uzawa, Toshitsugu Sugimoto

Open access · diamondAbstract read
In one paragraph

Article in Osteoporosis and sarcopenia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 34% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
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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

5 authors at 3 institutions in 1 country.

Hiroaki OkamotoDepartment of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
Nayumi ShibazakiClinical Development Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Takeshi YoshimuraMedical Affairs Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Toyonobu UzawaMedical Affairs Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Toshitsugu SugimotoEikokai Ono Hospital, Ono, Hyogo, Japan.
Asahi Kasei (Japan) · JPOno Pharmaceutical (Japan) · JPYokohama Municipal Citizen's Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesOn July 20, 2012, the European Medicines Agency (EMA) provided a recommendation that limits the long-term use of calcitonin. Based on this recommendation, we investigate the presence or absence of a cancer diagnosis in subjects who participated in the ongoing clinical trial of elcatonin.

methodsWhen the EMA gave this recommendation, we were conducting "a 3-year placebo-controlled clinical study for elcatonin" (hereinafter, referred to as "the original study"). In accordance with the recommendation of EMA, we performed an intermediate analysis on the subjects of the original study to assess whether the study could be safely continued. We also added a 2-year follow-up study to investigate the risk of carcinogenesis for 5 years from the start of administration. We compared the risk of carcinogenesis estimated by person-year method in elcatonin group with that in placebo group.

resultsIn the original study, there were 433 subjects in the elcatonin group and 437 in the placebo group, of whom 322 and 323, respectively, agreed to participate in the additional follow-up study. The average cancer incidence rate per 100 person-years 5 years from the start of administration was 1.02 in the elcatonin group and 1.08 in the placebo group, respectively, and there was no clear difference.

conclusionsSince the number of cases in this study was small, we cannot completely deny the cancer risk due to long-term administration of this drug. However, the results do not suggest that once-weekly administration of 20 units of elcatonin increases the carcinogenic risk.

Indexed as

CalcitoninCancer riskElcatoninOnce-weekly injectionOsteoporosis

Identifiers

PMID32226828
PMCPMC7093680
OpenAlexW3012040760

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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.