Evidence map›Paper›PMID 34002252›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 USA2021

A randomized, controlled trial of once-weekly teriparatide injection versus alendronate in patients at high risk of osteoporotic fracture: primary results of the Japanese Osteoporosis Intervention Trial-05.

H Hagino, T Sugimoto, S Tanaka, K Sasaki, T Sone, T Nakamura, S Soen, S Mori

Erratum issuedOpen access · hybridAbstract readRandomized Controlled Trial
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, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 37 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 5 pooled it
6.0field-weighted citation impact, top 2% 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

37 citing papers in PubMed, 5 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. PTH1 receptor agonists for fracture risk: a systematic review and network meta-analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
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  9. Association between renal function and fracture incidence during treatment with teriparatide or alendronate: an exploratory subgroup analysis of the Japanese Osteoporosis Intervention Trial-05.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

H HaginoSchool of Health Science, Tottori University Faculty of Medicine, Yonago, Tottori, Japan.ORCID https://orcid.org/0000-0001-8053-1095
T SugimotoEikokai Ono Hospital, 973 Tenjin-cho, Ono, Hyogo, Japan.
S TanakaDepartment of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.ORCID https://orcid.org/0000-0001-6817-5235
K SasakiDepartment of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
T SoneDepartment of Nuclear Medicine, Kawasaki Medical School, Kurashiki, Okayama, Japan.
T NakamuraJapan Osteoporosis Foundation, Tokyo, Japan.
S SoenSoen Orthopaedics, Osteoporosis and Rheumatology Clinic, Kobe, Hyogo, Japan.ORCID https://orcid.org/0000-0002-0955-2747
S MoriBone and Joint Surgery, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan. stmori@sis.seirei.or.jp.ORCID http://orcid.org/0000-0002-7660-5562
Kyoto University · JPKawasaki Medical School · JPOno Pharmaceutical (Japan) · JPSeirei Hamamatsu General Hospital · JPTottori University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this randomized, controlled trial, treatment with once-weekly subcutaneous injection of teriparatide for 72 weeks was found to be associated with a significant reduction in the incidence of morphometric vertebral fractures compared with alendronate in women with primary osteoporosis who were at high risk of fracture.

introductionTo determine whether the anti-fracture efficacy of teriparatide is superior to that of alendronate, a prospective, randomized, open-label, blinded-endpoint trial was performed.

methodsJapanese women aged at least 75 years were eligible for the study if they had primary osteoporosis and were at high risk of fracture. Patients were randomly assigned in a 1:1 ratio to receive sequential therapy (once-weekly subcutaneous injection of teriparatide 56.5 μg for 72 weeks followed by alendronate for 48 weeks) or monotherapy with alendronate for 120 weeks. The primary endpoint was the incidence of morphometric vertebral fractures at 72 weeks (at the end of teriparatide treatment).

resultsBetween October 2014 and December 2017, 1011 patients (505 in the teriparatide group and 506 in the alendronate group) were enrolled. Of these, 778 patients (351 and 427, respectively) were included in the primary analysis. The incidence of morphometric vertebral fractures was significantly lower in the teriparatide group (56 per 419.9 person-years, annual incidence rate 0.1334) than in the alendronate group (96 per 553.6 person-years, annual incidence rate 0.1734), with a rate ratio of 0.78 (95% confidence interval 0.61 to 0.99, P = 0.04). In both groups, adverse events were most frequently reported in the following system organ classes: infections and infestations, gastrointestinal disorders, and musculoskeletal and connective tissue disorders.

conclusionOnce-weekly subcutaneous injection of teriparatide significantly reduced the incidence of morphometric vertebral fractures compared with alendronate in women with primary osteoporosis who were at high risk of fracture.

trial registrationjRCTs031180235 and UMIN000015573, March 12, 2019.

Indexed as

Bone Density Conservation AgentsOsteoporosisOsteoporosis, PostmenopausalOsteoporotic FracturesSpinal FracturesAlendronateBone DensityFemaleHumansJapanProspective StudiesTeriparatideAlendronateBone Density Conservation AgentsTeriparatideBone-forming agentHigh risk of fractureNon-vertebral fractureVertebral fractureWeekly teriparatide

Identifiers

PMID34002252
PMCPMC8563544
OpenAlexW3162653190

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.