OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis

Kraus, Virginia B.; Blanco, Francisco J.; Englund, Martin; Henrotin, Yves; Lohmander, L. Stefan; Losina, Elena; Önnerfjord, Patrik; Persiani, Stefano

doi:10.1016/j.joca.2015.03.002

Cited by 76 publications

(76 citation statements)

References 47 publications

(69 reference statements)

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“…This finding suggested that TGF-α/CCL2 is an important promoter of articular cartilage degradation in posttraumatic OA. 26 In another study, oral administration of a high dose of BIS076 (245 mg/kg), a natural porcine cartilage extract associated with hydroxyapatite and vitamin D 3 , reduced serum levels of CTX-II and COMP, as well as MMP-3 in OVX and ACLT rats. 27 In ovariectomized (OVX) rats, serum COMP level was decreased by a combination of estrogen and progesterone hormones 10 weeks after OVX surgery.…”

Section: Ratsmentioning

confidence: 97%

“…in the development and testing of new drugs to advance decision making on dosing, time and treatment effect, trial design, and risk/benefit analysis. 3 …”

Section: Efficacy Of Interventionmentioning

confidence: 99%

“…2 Furthermore, soluble biomarkers can be used as "drug development tools" at preclinical stages and throughout clinical development in phase I to IV trials. 3 At the preclinical phases, the 3 major applications of biomarkers are their use in toxicology studies, in the selection of appropriate animal models and lead compounds and in the identification of the mechanisms of action of an intervention.…”

Section: Introductionmentioning

confidence: 99%

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Review of Soluble Biomarkers of Osteoarthritis: Lessons From Animal Models

et al. 2016

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Objective. Osteoarthritis (OA) is one of the leading causes of disability within the adult population. Currently, its diagnosis is mainly based on clinical examination and standard radiography. To date, there is no way to detect the disease at a molecular level, before the appearance of structural changes and symptoms. So an attractive alternative for monitoring OA is the measurement of biochemical markers in blood, urine, or synovial fluid, which could reflect metabolic changes in joint tissue and therefore disease onset and progression. Animal models are relevant to investigate the early stage of OA and metabolic changes occurring in joint tissues. The goal of this narrative review is to summarize the scientific data available in the literature on soluble biomarkers in animal models of OA. Design. A literature search was conducted using the PubMed/ Medline and Scopus databases between February 1995 and December 2015. All original articles, systematic and narrative reviews published in French or in English were considered. Results. We summarized the data of 69 studies and proposed a classification scheme for OA biomarkers in animal studies, largely inspired by the BIPEDS classification. Conclusions. Studies about biomarkers and animal models indicate that some markers could be valuable to monitor OA progression and assess therapeutic response in some animal models.

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Section: Ratsmentioning

confidence: 97%

“…in the development and testing of new drugs to advance decision making on dosing, time and treatment effect, trial design, and risk/benefit analysis. 3 …”

Section: Efficacy Of Interventionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Review of Soluble Biomarkers of Osteoarthritis: Lessons From Animal Models

et al. 2016

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“…Another study, which included 291 white patients with OA of the knee, it was found a significant increase in blood COMP levels in patients with K-L and consistent with the patient's score [18]. In 324 postmenopausal women, the study showed that the level of II CTX in different parts of OA was different, which suggested that OA can be identified in different parts of the patient [25]. Deficiencies and shortcomings of this study are as follows: firstly, the sample sizes were small, future studies should further expand the number of osteoarthritis patients to further study the possibility of miRNA98b as an early diagnosis of osteoarthritis.…”

Section: Study On the Clinical Value Of Mirna98b As A Potential Biomamentioning

confidence: 88%

Study on the clinical value of miRNA98b as a potential biomarker for osteoarthritis

Wang¹,

Ma²,

Xu³

et al. 2018

biomedicalresearch

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Objective: Osteoarthritis is a serious threat to the health of patients. Biomarkers have important significance in the diagnosis of bone arthritis. Bone mineral density is one of the important indicators for the detection of bone joint inflammation, but its detection is time-consuming and laborious. MicroRNA regulates cancer and inflammation. This study was to investigate the potential value of biomarkers miRNA98b in the diagnosis of early osteoarthritis. Methods: 69 cases of patients with osteoarthritis and 69 cases of healthy volunteers were regarded as research objects. Etidronate disodium had been continuously administrated for 4 w. The patient's bone density reached to the normal value which was regarded as effectiveness of the treatment. The miRNA98b level before and after therapy in blood cells of patients with osteoarthritis and healthy volunteers was detected by real time RT-PCR. The correlation between miRNA98b levels and osteoarthritis was analysed. Results: mRNA level of miRNA98b in blood cells of patients with osteoarthritis was higher than that of healthy volunteers. After being continuously administrated for 2 w, mRNA of miRNA98b in blood cells decreased, there was no significant change in the level of miRNA98b in blood cells of healthy volunteers. The level of miRNA98b in the blood cells of patients with severe osteoarthritis is higher than that in the blood cells of patients with general osteoarthritis, the difference was statistically significant (P<0.05). The level of miRNA98b in the blood cells of patients with osteoarthritis has a positive correlation with the severity of osteoarthritis. Conclusion: MiRNA98b in blood cells of patients with osteoarthritis may be a potential biomarker for osteoarthritis. The level of miRNA98b was correlated with the severity of osteoarthritis.

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“…There is significant interest in developing biochemical markers that can be used to measure the effects of interventions for knee OA on joint tissues 22 . In the present study, two potential markers of joint tissue inflammation (C1M and C3M) decreased over the course of an 18-month clinical trial in overweight and obese adults with knee OA assigned to dietary-induced weight loss or exercise plus weight loss interventions compared to an exercise without diet intervention that served as a control group.…”

Section: Discussionmentioning

confidence: 99%

Effects of dietary weight loss with and without exercise on interstitial matrix turnover and tissue inflammation biomarkers in adults with knee osteoarthritis: the Intensive Diet and Exercise for Arthritis trial (IDEA)

Loeser

Beavers

Bay‐Jensen

et al. 2017

Osteoarthritis and Cartilage

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Summary Objective To examine the effects of dietary weight loss, with and without exercise, on selected soluble biomarkers in overweight and obese older adults with symptomatic knee OA. Design Blood samples were analyzed from 429 participants in the IDEA trial randomized to either an 18 month exericse control group (E), weight loss diet (D), or D+E. C1M, C2M, C3M and CRPM biomarkers and IL-6 were quantitated using ELISAs. Radiographic progression was defined as a decrease in joint space width of ≥ 0.7mm. Statistical modeling of group means and associations used mixed models adjusted for visit, baseline BMI, gender, and baseline values of the outcome. Results Compared to the E control group, C1M was significantly lower in the D and D+E groups at both 6 and 18 months while C3M was significantly lower in D and D+E at 6 months and in D+E at 18 months. C2M did not change in any group. Using data from all groups, change in C1M (p<0.0001), C3M (p<0.0001), as well as CRPM (p=0.0004) from baseline to 18 months was positively associated with change in weight. No marker was associated with change in WOMAC pain or radiographic progression. C3M (p=0.008) and CRPM (p=0.028) were positively associated with change in WOMAC function. Change in IL-6 was positively associated with change in C1M, C3M, and CRPM. Conclusion Overweight and obese adults with knee OA who lost weight from diet and diet plus exercise reduced serum markers of interstitial matrix turnover and inflammation but not type II collagen degradation.

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OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis

Cited by 76 publications

References 47 publications

Review of Soluble Biomarkers of Osteoarthritis: Lessons From Animal Models

Review of Soluble Biomarkers of Osteoarthritis: Lessons From Animal Models

Study on the clinical value of miRNA98b as a potential biomarker for osteoarthritis

Effects of dietary weight loss with and without exercise on interstitial matrix turnover and tissue inflammation biomarkers in adults with knee osteoarthritis: the Intensive Diet and Exercise for Arthritis trial (IDEA)

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