Evidence map›Paper›PMID 31213783›Full record

Trial reportClinical interventions in aging2019

Effects of teriparatide in Chinese and Caucasian women with osteoporosis: bridging study on efficacy.

Zhongjian Xie, Yun Chen, Sirel Gurbuz, Bin Zhang, Yujie Li, Fan Bai, Yu Chen

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical interventions in aging, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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.

NCT00414973 phase3completednot on this map

Comparison of Teriparatide and Calcitonin in the Treatment of Men and Postmenopausal Women With Osteoporosis

TypeinterventionalSponsorEli Lilly and CompanyRan2006 to 2008Enrolled364ConditionsOsteoporosisArmsTeriparatide, Salmon Calcitonin
NCT00670501 phase3completednot on this map

Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis

TypeinterventionalSponsorEli Lilly and CompanyRan1996 to 1999Enrolled1,637ConditionsOsteoporosis, PostmenopausalArmsteriparatide, Placebo, Calcium Supplement, Vitamin D Supplement
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. 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

7 authors.

Zhongjian XieDepartment of Metabolism and Endocrinology, Hunan Provincial Key Laboratory of Metabolic Bone Diseases and National Clinical Research Center for Metabolic Diseases, The Second Xiangya Hospital, Central South University, Changsha, Hunan, China, zhongjian.xie@csu.edu.cn.
Yun ChenEli Lilly Suzhou Pharmaceutical Co., Ltd, Shanghai, People's Republic of China.
Sirel GurbuzEli Lilly and Company, Indianapolis, IN, USA.
Bin ZhangEli Lilly Suzhou Pharmaceutical Co., Ltd, Shanghai, People's Republic of China.
Yujie LiEli Lilly Suzhou Pharmaceutical Co., Ltd, Shanghai, People's Republic of China.
Fan BaiEli Lilly Suzhou Pharmaceutical Co., Ltd, Shanghai, People's Republic of China.
Yu ChenEli Lilly Suzhou Pharmaceutical Co., Ltd, Shanghai, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo bridge the efficacy and compare the safety of the 24-week teriparatide treatment in a Chinese osteoporosis study (NCT00414973) to a large international trial (FPT, NCT00670501) to determine whether long-term results from the international study were applicable to Chinese patients.

methodsIn this post-hoc analysis, a propensity score matching method was used to select patients with similar baseline characteristics. Patients were female with osteoporosis at high risk of fracture, aged ≥55 years, and had no history of rheumatoid arthritis or corticosteroid use. Outcomes included percentage changes in lumbar-spine bone mineral density (LS-BMD) from baseline to 24 weeks, safety in matched-pair patients, and long-term percentage changes in LS-BMD and fragility fracture incidence in the matched fracture prevention trial (FPT) population. The determination of the acceptability of bridging results was based on the International Conference on Harmonization E5 guidelines.

resultsA total number of 228 patients from each study were matched and paired. Patients were similar at baseline (

conclusionAssuming similar pharmacokinetic profiles for teriparatide between populations, comparable increases in LS-BMD and consistent safety profiles within 24 weeks of the treatment suggest long-term LS-BMD results from the FPT may be applicable to Chinese population.

Indexed as

Calcium-Regulating Hormones and AgentsTeriparatideAgedAsian PeopleBone DensityCalcitoninFemaleHumansLumbar VertebraeMatched-Pair AnalysisMiddle AgedOsteoporosisOsteoporotic FracturesTreatment OutcomeWhite PeopleCalcitoninCalcium-Regulating Hormones and AgentsTeriparatidebridgingfracture prevention trialLS-BMDlumbar spine-bone mineral densityosteoporosisteriparatide

Identifiers

PMID31213783
PMCPMC6542327

What OpenQuestion holds

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Registered trials

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.