Evidence map›Paper›PMID 30775537›Full record

ArticleOsteoporosis and sarcopenia2018

Safety and effectiveness of monthly intravenous ibandronate injections in a prospective, postmarketing, and observational study in Japanese patients with osteoporosis.

Yasuhiro Takeuchi, Junko Hashimoto, Yosuke Nishida, Chiemi Yamagiwa, Takashi Tamura, Akihide Atsumi

Open access · diamondAbstract read
In one paragraph

Article in Osteoporosis and sarcopenia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 39% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
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 1 institution in 1 country.

Yasuhiro TakeuchiEndocrine Center, Toranomon Hospital, Okinaka Memorial Institute for Medical Research, Tokyo, Japan.
Junko HashimotoProject & Lifecycle Management Unit, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Yosuke NishidaDrug Safety Division, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Chiemi YamagiwaDrug Safety Division, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Takashi TamuraDrug Safety Division, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Akihide AtsumiDrug Safety Division, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Toranomon Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis postmarketing, observational study evaluated the safety and effectiveness of monthly intravenous (IV) ibandronate in Japanese patients with osteoporosis.

methodsEligible patients received monthly IV ibandronate 1 mg for 12 months. Adverse drug reactions (ADRs) were evaluated. Changes in bone mineral density (BMD) and bone turnover markers (BTMs) were assessed using matched

resultsIn total, 1062 patients were enrolled, of whom 1025 (n = 887 women, n = 138 men) were treated. Mean patient age was 77 years. Seventy-five ADRs were reported in 54 patients (5.26%). Four patients (0.39%) experienced serious ADRs, including one case of osteonecrosis of the jaw. Acute-phase reactions occurred in 21 patients (2.04%), and half of them arose after the first ibandronate injection. No new safety concerns were identified. Significant increases in BMD at 12 months relative to baseline were observed at the lumbar spine (4.84%, n = 187; 95% confidence interval [CI], 3.47%-6.21%), femoral neck (2.73%, n = 166; 95% CI, 1.46%-4.01%), and total hip (1.93%, n = 133; 95% CI, 0.80%-3.07%). Significant reductions were observed in all BTMs at 12 months (n = 174 in tartrate-resistant acid phosphatase-5b, n = 101 in procollagen type 1 N-terminal propeptide at baseline). The cumulative incidence of nontraumatic, new vertebral and nonvertebral fractures was 3.16% (95% CI, 2.12%-4.70%). Analyses in women only showed similar results to the overall population.

conclusionsThese findings confirm the favorable safety and consistent effectiveness of ibandronate, and indicate that monthly IV ibandronate would be beneficial in daily practice for the treatment of Japanese patients with osteoporosis.

Indexed as

IbandronateIntravenousJapanOsteoporosisProspective observational study

Identifiers

PMID30775537
PMCPMC6362972
OpenAlexW2792039510

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Registered trials

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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.