Evidence map›Paper›PMID 28631217›Full record

ArticleAdvances in therapy2017

24-Month Open-Label Teriparatide Once-Weekly Efficacy Research Trial Examining Bone Mineral Density in Subjects with Primary Osteoporosis and High Fracture Risk.

Toshitsugu Sugimoto, Masataka Shiraki, Masao Fukunaga, Hiroshi Hagino, Teruki Sone, Tetsuo Nakano, Hideaki Kishimoto, Masako Ito, Hideki Yoshikawa, Mitsukazu Kishida and 2 more

Abstract readMulticenter Study
In one paragraph

Article in Advances in therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
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

12 citing papers in PubMed.

  1. Trial
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  3. Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
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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

12 authors.

Toshitsugu SugimotoInternal Medicine 1, Shimane University Faculty of Medicine, Izumo, Shimane, Japan. sugimoto@med.shimane-u.ac.jp.ORCID 0000-0003-0627-1816
Masataka ShirakiResearch Institute and Practice for Involutional Diseases, Azumino, Nagano, Japan.
Masao FukunagaKawasaki Medical School, Kurashiki, Okayama, Japan.
Hiroshi HaginoSchool of Health Science, Tottori University, Yonago, Tottori, Japan.
Teruki SoneDepartment of Nuclear Medicine, Kawasaki Medical School, Kurashiki, Okayama, Japan.
Tetsuo NakanoTamana Central Hospital, Tamana, Kumamoto, Japan.
Hideaki KishimotoNojima Hospital, Kurayoshi, Tottori, Japan.
Masako ItoCenter for Diversity and Inclusion, Nagasaki University, Nagasaki, Nagasaki, Japan.
Hideki YoshikawaDepartment of Orthopaedic Surgery, Graduated School of Medicine, Osaka University, Suita, Osaka, Japan.
Mitsukazu KishidaAsahi Kasei Pharma Corporation, Chiyoda-ku, Tokyo, Japan.
Chika IrieAsahi Kasei Pharma Corporation, Chiyoda-ku, Tokyo, Japan.
Toshitaka NakamuraTouto Sangenjaya Rehabilitation Hospital, Setagaya-ku, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo clarify the additional efficacy and safety benefits of 24 months' treatment with the once-weekly formulation of teriparatide, which is currently used for 72 weeks.

methodsThis was a multicenter, open-label, single-arm study conducted in Japan. Subjects who were 65 years or older with prevalent vertebral fractures received once-weekly subcutaneous injection of 56.5 μg teriparatide for 24 months. The main outcome measure was percentage change from baseline in lumbar (L2-L4) BMD measured by dual-energy X-ray absorptiometry.

resultsA total of 189 subjects received at least one dose of the once-weekly formulation of teriparatide. Lumbar, femoral neck, and total hip BMD increased significantly compared with baseline at Weeks 24, 48, 72, and 104. In addition, significant increases in lumbar (+1.5%) and femoral neck (+0.8%) BMD were noted at Week 104 compared with Week 72. Significant increases from baseline in BMD for radius 1/10 were noted at Weeks 24 and 104. No substantial increases were noted in the cumulative incidences of new vertebral fracture and other types of fracture after Week 72. The safety profile seen in the first 72 weeks remained unchanged until 104 weeks.

conclusionThe once-weekly formulation of teriparatide is effective and safe for the treatment of osteoporosis over 24 months. The limitation of this study is that this was an open-label, single-arm study.

fundingAsahi Kasei Pharma Corporation. CLINICAL

trial registrationJapicCTI-132276.

Indexed as

Absorptiometry, PhotonAgedBone DensityBone Density Conservation AgentsFemaleFractures, BoneHumansJapanMaleOsteoporosisRisk AssessmentSpinal FracturesTeriparatideBone Density Conservation AgentsTeriparatideBone mineral densityOnce-weekly injectionOsteoporosisRadiusTeriparatideTreatment response

Identifiers

PMID28631217
PMCPMC5504212

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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.