Methodologic issues in clinical trials for prevention or risk reduction in osteoarthritis

Jordan, Joanne M.; Sowers, MaryFran; Messier, Stephen P.; Bradley, John; Arangio, George A.; Katz, Jeffrey N.; Losina, Elena; Rovati, Lucio C.; Bachtell, Nathan; Cooper, Cyrus; Spector, Tim D.; Zhang, Weiya; Gardiner, Joseph C.; Wahba, Mahmoud

doi:10.1016/j.joca.2010.10.031

Cited by 22 publications

(20 citation statements)

References 36 publications

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“…According to EFSA [39]: 'normal cells and tissues are genetically (gene expression) and functionally different from osteoarthritic cells and tissues and therefore may respond differently to interventions with exogenous substances' and 'the mechanisms involved in the onset and/or progression of osteoarthritis are largely unknown, so that it cannot be established that an intervention which has an effect on the progression of the disease (in patients with osteoarthritis), would also have an effect on its onset (subjects without the disease)'. On this subject the NDA Panel considered the findings of a study by Jordan et al [64] entitled 'Methodological issues in clinical trials for prevention or risk reduction in osteoarthritis', published in 2011. The NDA Panel viewpoint on the eligible study populations is clear [39]: the demonstration of the health claims on joints has to be established in human intervention studies performed in non-diseased (including high risk) population subgroups (e.g.…”

Section: Discussionmentioning

confidence: 99%

Supplements in the European Union: An Analysis of Health Claims Related to Articular Joint Health

Bettencourt-Câmara

Sepodes²,

Bronze³

et al. 2016

EJNFS

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In the European Union, amino acids, enzymes, pre-and probiotics, essential fatty acids, botanicals and botanical extracts and miscellaneous bioactive substances can be marketed as food supplements (FS). Food supplements that are meant to benefit human health contain claims on their label stating their benefits. Since 2007, health claims made on FS, are prohibited unless they are authorized and included in the EU Register of Nutrition and Health Claims on Food (the EU Register), in accordance with the requirements of Regulation (EC) nº 1924/2006. Aims: This manuscript reviews the evidence required to support health claims made on FS considering the legal framework of these foodstuffs and, as a case study, analyses the health claims on articular joint health included in the EU Register. The EFSA scientific opinions related to those health claims have also been considered. In EU, some botanicals and miscellaneous bioactive substances can be marketed as medicinal or as food supplements. The regulatory issues on botanicals and the debate on how to create a regulatory framework for botanicals is mentioned. Results: By April 2015, 77 functional health claims on joints health were included in the EU Register. The status of all these claims was non-authorised. The great majority were Article 13.1 claims (91%). All functional claims related to articular joints function were made on target functional ingredients, mainly other substances that could be used in the manufacturing of FS. Human trials Bettencourt-Câmara et al.; EJNFS, 6(1): 12-35, 2016; Article no.EJNFS.2016.003 13 conducted in diseased population were the main statement from EFSA for the non-approval of the health claims on articular joints. Criteria and more guidance addressing methodological issues on human trials would benefit future applications and scientific research. Conclusion: Legal issues regarding other substances than vitamins and minerals, namely botanical ingredients should also be taken in account in future FS health claims on articular joints. On this subject, efforts to improve the existing regulatory framework, namely with regard to botanicals products could also benefit future FS health claims. Review Article

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Section: Discussionmentioning

confidence: 99%

Supplements in the European Union: An Analysis of Health Claims Related to Articular Joint Health

Bettencourt-Câmara

Sepodes²,

Bronze³

et al. 2016

EJNFS

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“…This will require careful consideration of the statistical methods since the distinction between new disease development and progression may be difficult to discern (Jordan et al . ). In 2014 a RCT was registered in The Netherlands to examine the efficacy of high resistance muscle strength training with and without vitamin D supplementation in terms of knee pain, instability and inflammation (EudraCT: 2014‐000047‐33).…”

Section: Vitamin D Supplementationmentioning

confidence: 97%

Dietary intervention for osteoarthritis: Clinical trials after the ‘Bone and Joint Decade’

Davidson

Clark

2015

Nutrition Bulletin

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Osteoarthritis (OA) is a major social and economic burden that continues to grow globally with no effective disease modifying therapies in the pipeline. Current therapeutic strategies to address pain are largely insufficient and joint replacement for end stage disease is unsustainable. Drug development is particularly difficult and expensive due to the complexity of balancing efficacy and toxicity for chronic diseases. The main risk factors for developing OA are increasing age and obesity. Diet has a clear link to the latter, but also impacts strongly on the ageing process. There is no paucity of pre‐clinical data investigating dietary bioactives and their impact on OA disease models. However clinical trials that test these data using relevant trial design and validated outcome measures are scarce. Current trials focus on vitamin D, fish oil omega fatty acids and curcumin. This review examines recently completed, current or proposed clinical trials of dietary bioactives and their utility in developing an OA therapeutic strategy either prophylactically or as a means of OA management. The number of scientifically high quality trials in the pipeline is low. There is an unmet need for investment in clinical trials of dietary intervention, for developing disease biomarkers (both biochemical and imaging) and refining the definition of OA so that clinically relevant outcome measures can be improved.

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“…The Panel also notes, in particular, that the pathobiology of the onset and early progression of OA is poorly defined. The evidence provided by consensus opinions/reports from authoritative bodies indicates that normal cells and tissues are genetically (gene expression) and functionally different from osteoarthritic cells and tissues, and therefore may respond differently to intervention with exogenous substances (FDA, 2004a,b;Jordan et al, 2011). The Panel also notes that the evidence provided for the proposed mechanisms which would explain an effect of glucosamine on joint cartilage is weak (see below).…”

Section: Human Studies In Patients With Osteoarthritismentioning

confidence: 99%

Scientific Opinion on the substantiation of a health claim related to glucosamine and maintenance of normal joint cartilage pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Publication¹

2012

EFSA Journal

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Following an application from Merck Consumer Healthcare, submitted pursuant to Article 13(5) of Regulation (EC) via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to glucosamine, formulated as glucosamine sulphate or hydrochloride, and maintenance of normal joint cartilage. Glucosamine is sufficiently characterised. The claimed effect is "contributes to the maintenance of normal joint cartilage". The target population as proposed by the applicant is the general population, and in particular people exposing their joints to high mechanical load and people with joint cartilage deterioration due to normal ageing. The Panel considers that the maintenance of normal joint cartilage is a beneficial physiological effect. The applicant provided references to studies in patients with osteoarthritis, in healthy subjects, in animals and in vitro as being pertinent to the health claim. In weighing the evidence, the Panel took into account that no human studies were provided from which conclusions could be drawn on the effect of dietary glucosamine on the maintenance of cartilage in individuals without osteoarthritis, and that the evidence provided in the in vitro and animal studies in support of the biological plausibility for a possible contribution of dietary glucosamine to the maintenance of joint cartilage in humans is weak. The Panel concludes that a cause and effect relationship has not been established between the consumption of glucosamine and maintenance of normal joint cartilage in individuals without osteoarthritis. © European Food Safety Authority, 2012 The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. KEY WORDSThe food constituent that is the subject of the health claim is glucosamine, formulated as glucosamine sulphate or hydrochloride. The Panel considers that glucosamine is sufficiently characterised.The claimed effect is "contributes to the maintenance of normal joint cartilage". The target population as proposed by the applicant is the general population, and in particular people exposing their joints to high mechanical load, for example through extensive sports activities or obesity, and people with joint cartilage deterioration due to normal ageing. From the information provided, the Panel notes that the claimed effect relates to the maintenance of joint cartilage. The Panel considers that the maintenance of normal joint cartilage is a beneficial physiological effect.In the original application, the applicant identified a total of 61 references as being pertinent to the health claim. These references comprised 20 references describing 12 human intervention studies, 13 reviews on the effects of glucosamine supplementation on maintenance of joints, four animal studies on the effects of glucosamine on joints, 14 in vitro studies on the effects of glucosamine on cartilage cells/tissues, nine studies i...

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Methodologic issues in clinical trials for prevention or risk reduction in osteoarthritis

Cited by 22 publications

References 36 publications

Supplements in the European Union: An Analysis of Health Claims Related to Articular Joint Health

Supplements in the European Union: An Analysis of Health Claims Related to Articular Joint Health

Dietary intervention for osteoarthritis: Clinical trials after the ‘Bone and Joint Decade’

Scientific Opinion on the substantiation of a health claim related to glucosamine and maintenance of normal joint cartilage pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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