Evidence map›Paper›PMID 31481084›Full record

Trial reportArthritis research & therapy2019

Associations between biomarkers of bone and cartilage turnover, gender, pain categories and radiographic severity in knee osteoarthritis.

Asger Reinstrup Bihlet, Inger Byrjalsen, Anne-Christine Bay-Jensen, Jeppe Ragnar Andersen, Claus Christiansen, Bente Juel Riis, Morten A Karsdal

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Arthritis research & therapy, 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 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
6.1field-weighted citation impact, top 3% 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.

NCT00486434 phase3completednot on this map

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee Osteoarthritis

TypeinterventionalSponsorNordic Bioscience A/SRan2007 to 2010Enrolled1,176ConditionsOsteoarthritisArmsSMC021 Oral Calcitonin, SMC021 Placebo
NCT00704847 phase3terminatednot on this map

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee Osteoarthritis

TypeinterventionalSponsorNordic Bioscience A/SRan2008 to 2011Enrolled1,030ConditionsOsteoarthritisArmsOral Salmon Calcitonin, Oral Salmon Calcitonin (Placebo)
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.

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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

7 authors at 1 institution in 1 country.

Asger Reinstrup BihletNordic Bioscience Clinical Development, Herlev Hovedgade 82, DK2730, Herlev, Denmark. abi@nordicbioscience.com.ORCID 0000-0002-6944-1731
Inger ByrjalsenNordic Bioscience Clinical Development, Herlev Hovedgade 82, DK2730, Herlev, Denmark.
Anne-Christine Bay-JensenNordic Bioscience Biomarkers and Research, Herlev Hovedgade 207, DK2730, Herlev, Denmark.
Jeppe Ragnar AndersenNordic Bioscience Clinical Development, Herlev Hovedgade 82, DK2730, Herlev, Denmark.
Claus ChristiansenNordic Bioscience A/S, Herlev Hovedgade 207, DK2730, Herlev, Denmark.
Bente Juel RiisNordic Bioscience A/S, Herlev Hovedgade 207, DK2730, Herlev, Denmark.
Morten A KarsdalNordic Bioscience Biomarkers and Research, Herlev Hovedgade 207, DK2730, Herlev, Denmark.
Nordic Bioscience (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundExcessive cartilage degradation is a known characteristic of osteoarthritis (OA). Biochemical markers, such as uCTX-II, have been shown to be associated with disease severity, yet the tissue origin of CTX-II has been disputed. This analysis investigates the association between OA knee joints at different radiographic stages and pain categories with levels of uCTX-II and biomarkers of bone resorption and formation.

methodsBaseline data of two randomised clinical trials (NCT00486434 and NCT00704847) in patients with radiographic OA and presence of pain were analysed post hoc. A subgroup with available urine samples and evaluable radiographs for both knees (N = 1241) was analysed. Urine CTX-I, urine CTX-II and serum osteocalcin were analysed for associations with combined Kellgren-Lawrence (KL) scores, gender and pain for both knees to assess the contribution of joints at different stages.

resultsPain, BMI, age, gender and KL grade were all significantly associated with uCTX-II. The association between pain and CTX-II appeared to be driven by weight-bearing pain. The level of uCTX-II incrementally increased with higher radiographic severity of each knee. Levels of bone markers CTX-I and osteocalcin were both significantly associated with BMI and gender, but neither were associated with radiographic severity. Biomarker levels between male or female groups of identical KL scores were found to be higher in females compared to males in some but not all KL score groups.

conclusionsThese results indicate that levels of uCTX-II are independently associated with radiographic severity of OA and pain intensity. CTX-II was associated with weight-bearing pain, but not non-weight-bearing pain, independent of co-variates. Bilateral OA knee joints appear to contribute to uCTX-II levels in an incremental manner according to radiographic severity of single joints. The data suggest that biomarker differences between genders should be taken into account when evaluating these markers in the context of structural features of OA.

Indexed as

AgedAged, 80 and overBiomarkersBone and BonesCartilage, ArticularCartilage Oligomeric Matrix ProteinCollagen Type ICollagen Type IICross-Sectional StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedOsteoarthritis, KneePeptidesBiomarkersCartilage Oligomeric Matrix ProteinCollagen Type ICollagen Type IIcollagen type I trimeric cross-linked peptidePeptidesBiomarkersBoneCartilageOsteoarthritisPainRadiography

Identifiers

PMID31481084
PMCPMC6724319
OpenAlexW2971647493

What OpenQuestion holds

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LicenceCC BY
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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.