Evidence map›Paper›PMID 33426308›Full record

ArticleOsteoporosis and sarcopenia2020

A 3-year postmarketing study on the safety and effectiveness of once-monthly risedronate in Japanese patients with osteoporosis.

Satoshi Soen, Yuki Arai, Saori Matsuda, Kento Emori, Toshimi Ikezaki, Mitsuharu Osawa

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
0.5field-weighted citation impact, top 36% 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, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Observational
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

6 authors at 2 institutions in 1 country.

Satoshi SoenSoen Orthopaedics, Osteoporosis and Rheumatology Clinic, Kobe, Japan.
Yuki AraiPost-Marketing Medical Research Group, Medical Department, EA Pharma Co., Ltd., Tokyo, Japan.
Saori MatsudaPost-Marketing Medical Research Group, Medical Department, EA Pharma Co., Ltd., Tokyo, Japan.
Kento EmoriClinical Development Department, Data Science Group, EA Pharma Co., Ltd., Tokyo, Japan.
Toshimi IkezakiClinical Planning Department, Medical HQs, Eisai Co., Ltd., Tokyo, Japan.
Mitsuharu OsawaClinical Planning Department, Medical HQs, Eisai Co., Ltd., Tokyo, Japan.
EA Pharma (Japan) · JPEisai (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis postmarketing study aims to evaluate the safety and effectiveness of oral administration of risedronate at 75 mg once monthly for 36 months in patients with osteoporosis in Japan.

methodsParticipants were ambulatory outpatients with osteoporosis who were ≥ 50 years old and had prevalent vertebral fractures. Outcomes were the incidence rate of adverse drug reaction (ADR), cumulative incidence of vertebral, nonvertebral, and hip fractures, the percent changes of lumbar spinal L

resultsSafety, vertebral fractures, and other outcomes were analyzed in 542, 328, and 535 patients, respectively. In the safety analysis set, 88.38% of the patients were women and the mean age was 75.9 years. The monthly medication compliance rate ranged from 83.24% to 95.38%. The incidence rate of ADRs, including 4 severe ADRs, was 10.52% (n = 57). The common ADRs were gastrointestinal disorders, musculoskeletal, and connective tissue disorders. No osteonecrosis of the jaw was reported. The cumulative incidences (95% CI) of vertebral, nonvertebral, and hip fractures at 36 months were 12.58% (8.61-18.18), 6.59% (4.31-10.01), and 1.58% (0.64-3.88), respectively. The L

conclusionsAdministering 75 mg of risedronate once a month remains a favorable compliance rate and may be useful for the treatment of patients, even the elderly, with osteoporosis in daily practice.

Indexed as

Low back painMedication complianceOnce-monthly risedronateOsteoporosisPostmarketing surveyVertebral fracture

Identifiers

PMID33426308
PMCPMC7783076
OpenAlexW3108731245

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.