Evidence map›Paper›PMID 39223504›Full record

Observational studyBMC musculoskeletal disorders2024

Change in body temperature, not acute-phase reaction, predict anti-Osteoporosis efficacy after the first administration of Zoledronic acid: a prospective observational cohort study.

Yanping Du, Weijia Yu, Haixin Gou, Yiming Lei, Tongkai Zhang, Wenjing Tang, Minmin Chen, Huilin Li, Qun Cheng

Registry-linked trialAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in BMC musculoskeletal disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03158246 (Generic Zoledronic Acid Versus Original Zoledronic Acid), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT03158246 phase4unknown statusnot on this map

Generic Zoledronic Acid Versus Original Zoledronic Acid: A Multicenter, Randomized, Open, Paralled-controlled Clinical Postmenopausal Osteoporotic Women Efficacy and Safety Research.

TypeinterventionalSponsorCttqRan2017 to 2020Enrolled466ConditionsOsteoporosis, PostmenopausalArmsGeneric Zoledronic Acid, Original Zoledronic Acid, calcium, vitamin D
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

9 authors.

Yanping Du *Department of Osteoporosis and Bone Disease, Research Section of Geriatric Metabolic Bone Disease, Huadong Hospital Affiliated to Fudan University, Shanghai Geriatric Institute, Shanghai, China.
Weijia Yu *Department of Osteoporosis and Bone Disease, Research Section of Geriatric Metabolic Bone Disease, Huadong Hospital Affiliated to Fudan University, Shanghai Geriatric Institute, Shanghai, China.
Haixin GouDepartment of Traditional Chinese Medicine, Huadong Hospital Affiliated to Fudan University, Shanghai, China.
Yiming LeiDepartment of Traditional Chinese Medicine, Huadong Hospital Affiliated to Fudan University, Shanghai, China.
Tongkai ZhangDepartment of Massage, Huadong Hospital Affiliated to Fudan University, Shanghai, China.
Wenjing TangDepartment of Osteoporosis and Bone Disease, Research Section of Geriatric Metabolic Bone Disease, Huadong Hospital Affiliated to Fudan University, Shanghai Geriatric Institute, Shanghai, China.
Minmin ChenDepartment of Osteoporosis and Bone Disease, Research Section of Geriatric Metabolic Bone Disease, Huadong Hospital Affiliated to Fudan University, Shanghai Geriatric Institute, Shanghai, China.
Huilin LiDepartment of Osteoporosis and Bone Disease, Research Section of Geriatric Metabolic Bone Disease, Huadong Hospital Affiliated to Fudan University, Shanghai Geriatric Institute, Shanghai, China.
Qun ChengDepartment of Osteoporosis and Bone Disease, Research Section of Geriatric Metabolic Bone Disease, Huadong Hospital Affiliated to Fudan University, Shanghai Geriatric Institute, Shanghai, China. quncheng_2014@163.com.

Funding

Bethune Foundation Project G-X-2019-1107-2Bethune Foundation Project GX2021C04National Key R&D Program of China 2018YFC2000201National Key R&D Program of China 2018YFC2000205Shanghai Municipal Health Commission 20214Y0519Shanghai Science and Technology Commission Science and Technology Innovation Action Plan Industry University Research Medical Cooperation Project 17DZ1920206
6 · The paper itself

Abstract

backgroundAcute-phase reactions (APRs) are common among people treated for the first time with zoledronate (ZOL). The current view is that both the APRs caused by ZOL and its efficacy are related to the mevalonic acid pathway. However, the relationship between APRs and ZOL efficacy remains unclear.

methodsThis was a prospective observational cohort study involving postmenopausal women with osteoporosis in Shanghai, China, for 1 year. A total of 108 patients with an average age of 67.4 ± 5.8 years were treated with 5 mg intravenous ZOL for the first time. Data on demographic characteristics, APRs, blood counts, bone turnover markers, including C-telopeptide collagen crosslinks (CTX) and N-terminal propeptide of type 1 collagen (PINP), and bone mineral density (BMD) were collected.

results(1) The results did not reveal a relationship between APRs and changes in bone turnover markers and BMD but showed that changes in body temperature (T) within 3 days after administration were positively correlated with changes in the BMD of the LS at Month 12 (β = 0.279 P = 0.034). (2) This effect was mediated mainly by changes in serum CTX (b = 0.046, 95% CI [0.0010-0.0091]). (3) The ROC curve revealed that when T increased by 1.95 °C, the sensitivity and specificity of identifying clinically important changes in LS BMD after 1 year were optimized.

conclusionsIn this study, we tested the hypothesis that people with elevated body T after initial ZOL treatment had greater improvements in BMD and better outcomes.

trial registrationNCT, NCT03158246. Registered 18/05/2017.

Indexed as

Acute-Phase ReactionBody TemperatureBone DensityBone Density Conservation AgentsDiphosphonatesImidazolesZoledronic AcidAgedBiomarkersCohort StudiesFemaleHumansMiddle AgedOsteoporosis, PostmenopausalPredictive Value of TestsProspective StudiesBiomarkersBone Density Conservation AgentsDiphosphonatesImidazolesZoledronic AcidAcute-phase reactionBody temperatureEfficacyOsteoporosisZoledronic acid

Identifiers

PMID39223504
PMCPMC11367990

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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.