Evidence map›Paper›PMID 31392401›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2019

Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study.

T Sugimoto, M Shiraki, M Fukunaga, H Kishimoto, H Hagino, T Sone, T Nakano, M Ito, H Yoshikawa, T Minamida and 2 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.1field-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

22 citing papers in PubMed, 35 citations in OpenAlex.

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  5. Baseline serum PINP is associated with early lumbar spine bone mineral density gains during twice-weekly teriparatide treatment: the OASIS cohort study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
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  19. Adult hypophosphatasia treated with reduced frequency of teriparatide dosing.Journal of musculoskeletal & neuronal interactions · 2021
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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 at 9 institutions in 1 country.

T SugimotoInternal Medicine 1, Shimane University Faculty of Medicine, 89-1 Ennya-cho, Izumo, Shimane, 693-8501, Japan. sugimoto@med.shimane-u.ac.jp.ORCID http://orcid.org/0000-0003-0627-1816
M ShirakiResearch Institute and Practice for Involutional Diseases, 1610-1 Misatomeisei, Azumino, Nagano, 399-8101, Japan.
M FukunagaKawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.
H KishimotoNojima Hospital, 2714-1 Sesakimachi, Kurayoshi, Tottori, 682-0863, Japan.
H HaginoSchool of Health Science, Tottori University, 86 Nishicho, Yonago, Tottori, 683-8503, Japan.
T SoneDepartment of Nuclear Medicine, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.
T NakanoTamana Central Hospital, 1950 Naka, Tamana, Kumamoto, 865-0064, Japan.
M ItoCenter for Diversity and Inclusion, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8520, Japan.
H YoshikawaDepartment of Orthopaedic Surgery, Graduated School of Medicine, Osaka University, 1-1 Yamadaoka, Suita, Osaka, 565-0871, Japan.
T MinamidaAsahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.
Y TsuruyaAsahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.
T NakamuraToto Sangenjaya Rehabilitation Hospital, 1-24-3 Sangenjaya, Setagaya-ku, Tokyo, 154-0024, Japan.
Asahi Kasei (Japan) · JPKawasaki Medical School · JPKajima Corporation (Japan) · JPKumamoto Chuo Hospital · JPMinebeaMitsumi (Japan) · JPNagasaki University · JPShimane University · JPThe University of Osaka · JPTottori University · JP

Funding

Asahi Kasei Pharma Corporation -
6 · The paper itself

Abstract

A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial (the TWICE study) conducted in Japanese primary osteoporosis patients with a high risk of fractures demonstrated that a 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen of teriparatide, while also improving safety.

introductionWhile a 56.5-μg once-weekly regimen of teriparatide has high efficacy for osteoporosis, treatment continuation rates are low, with one of the major causes being adverse drug reactions such as nausea or vomiting. The TWICE study was therefore conducted to investigate whether a twice-weekly regimen with 28.2-μg teriparatide can provide comparable efficacy to the 56.5-μg once-weekly regimen while improving safety.

methodsA 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan. Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276). The primary endpoint was the percentage change in lumbar spine (L2-L4) bone mineral density (BMD) at final follow-up.

resultsThe percentage changes in lumbar spine (L2-L4) BMD at final follow-up in the 28.2-μg twice-weekly and 56.5-μg once-weekly groups were 7.3% and 5.9%, respectively; the difference (95% confidence interval [CI]) in percentage change was 1.3% (0.400-2.283%). Since the lower limit of the 95% CI was above the pre-specified non-inferiority margin (- 1.6%), non-inferiority of the 28.2-μg twice-weekly group was demonstrated. Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group.

conclusionsA 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen while improving safety. CLINICAL

trial registrationJapicCTI-163477 .

Indexed as

AgedAged, 80 and overBone DensityBone Density Conservation AgentsDouble-Blind MethodDrug Administration ScheduleFemaleHumansJapanLumbar VertebraeMaleOsteoporosisOsteoporotic FracturesRisk FactorsTeriparatideTreatment OutcomeBone Density Conservation AgentsTeriparatideBone mineral densityOsteoporosisRandomized controlled trialSafetyTeriparatideTwice-weekly

Identifiers

PMID31392401
PMCPMC6811384
OpenAlexW2965220485

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.