Role of Copper-Albumin Complex in Treatment of Knee Osteoarthritis in Human

• ClinicalTrials.gov Identifier: NCT03736109
• Recruitment Status: Unknown
• First Posted: November 8, 2018
• Last Update Posted: January 10, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Reham I El-mahdy, Assiut University

Study Description

Brief Summary:

Osteoarthritis (OA) is one of the most common forms of degenerative joint disease and a major cause of pain and disability affecting the aging population. It is a significant burden in terms of cost as well as the health of society and individuals. Here in our study we will try to evaluate a novel therapeutic method by using topical copper-albumin complexes cream in treatment of osteoarthritis. Then all the biochemical changes will be measured beside the evaluation of topical copper-albumin complexes cream effectiveness in relieving symptoms of the OA.

Condition or disease	Intervention/treatment
Osteo Arthritis Knee	Genetic: Soluble and genetic biomarkers measurements

Detailed Description:

Osteoarthritis (OA) is a complex disease process involving the whole synovial joint. In OA articular cartilage is lost through a combination of degenerative and inflammatory phenomena, which are often accompanied by joint swelling, pain, stiffness and loss of joint mobility. The pathogenesis of OA is multifactorial and is considered to be a metabolically active process, predominantly due to the poor regenerative properties of articular cartilage after damage. The most commonly affected joint is the knee, and OA has a higher occurrence in older adults particularly women. Because patients generally present in the clinic after these symptoms of the illness develop, most treatment techniques for OA are designed to address these symptoms rather than cure the underlying disease. Current conservative treatments include lifestyle modification and pain medication (such as NSAIDs) which predominantly treat the illness (e.g., pain symptoms). There is also some promise in the use of chondroitin to decrease joint space narrowing in OA, thus treating the disease itself. Conversely, surgical intervention (partial or total joint replacement) is the preferred treatment method in end-stage disease leading to some relief of both the illness and disease.

Copper complexes can biochemically affect the cells and impinge upon metabolic pathways especially highly effective copper dependent enzymes, such as superoxide dismutase (SOD). It is predicted also that copper containing vitamins or biochemically active organic compounds such as amino acids and peptides or synthetic organic compounds in complexes can effectively scavenge superoxide radical. Additionally, recent studies showed that Cu (II) Bis (diethyldithiocarbamate) induced the expression of syndecan-4, a transmembrane heparan sulfate proteoglycan, in a dose- and time-dependent manner n via the activation of p38 mitogen-activated protein kinase. This submitted work has been designed to evaluate a copper chelating complex consisting of egg albumin and copper as one of the copper peptides that can be used as anti-inflammatory agent and chondroprotective in OA treatment that could be used as a substitute especially the currently used chondroprotective drugs are expensive and frequent using of drugs such as non-steroidal anti-inflammatory drugs (NSAIDs), known to be aggressive agents for gastric ulcer development.

Study Design

• Study Type: Observational
• Estimated Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Role of Copper-Albumin Complex in Treatment of Knee Osteoarthritis in Human:a Pilot Prospective Comparative Study
• Estimated Study Start Date: January 17, 2019
• Estimated Primary Completion Date: March 20, 2019
• Estimated Study Completion Date: March 30, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Group I: Thirty patients with knee osteoarthritis taking topical Copper-Albumin Complex cream	Genetic: Soluble and genetic biomarkers measurements; Insulin-Like Growth Factor-1 and Coll2-1 gene expression will be measured by real time PCR. In addition, syndecan 4, hyaluronic acid, substance P and nitric oxide will be measured in plasma by ELISA
Group II: Thirty patients with knee osteoarthritis taking oral chondroprotective drugs	Genetic: Soluble and genetic biomarkers measurements; Insulin-Like Growth Factor-1 and Coll2-1 gene expression will be measured by real time PCR. In addition, syndecan 4, hyaluronic acid, substance P and nitric oxide will be measured in plasma by ELISA

Outcome Measures

Primary Outcome Measures :

1. The mean difference of syndecan 4 expression and substance P before and after treatment [ Time Frame: 2 months ]
   better understanding the efficacy of the Copper-Albumin Complex treatment for knee osteoarthritis

Secondary Outcome Measures :

1. Pain improvement [ Time Frame: 2 months ]
   Visual Analog Score for pain

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

Knee osteoarthritis patients

Criteria

Inclusion Criteria:

• Patients of both sexes and over 40 years of age diagnosed with unilateral or bilateral symptomatic OA of the knee who met the criteria of the American College of Rheumatology (ACR).
• Patients who were rated grade II or III on the Kellgren and Lawrence (K&L) radiological scale [19].
• Patients with symptomatic OA with a global mean pain in the knee >40 mm on a Visual Analogue Scale (VAS) for pain assessment.

Exclusion Criteria:

• Women who were pregnant or breastfeeding
• Patients who were grade I or IV on K&L radiological scale.
• Patients who have had a prosthesis replaced in the 12 months prior to inclusion.
• Obesity

Contacts and Locations

Contacts

Contact: reham elmahdy, Lecturer; +201002714637; rehamibrahimelmahdy@gmail.com

Contact: Ahmed yassein nassar, Professor; +201149511340; aynassar41@yahoo.com

Sponsors and Collaborators

Assiut University

More Information

Publications:

Bai Z, Guo XH, Tang C, Yue ST, Shi L, Qiang B. Effects of Artesunate on the Expressions of Insulin-Like Growth Factor-1, Osteopontin and C-Telopeptides of Type II Collagen in a Rat Model of Osteoarthritis. Pharmacology. 2018;101(1-2):1-8. doi: 10.1159/000479160. Epub 2017 Sep 13.

Duncan C, White AR. Copper complexes as therapeutic agents. Metallomics. 2012 Feb;4(2):127-38. doi: 10.1039/c2mt00174h. Epub 2011 Dec 20. Review.

Möller I, Gharbi M, Martinez Serrano H, Herrero Barbero M, Verges Milano J, Henrotin Y. Effect of chondroitin sulfate on soluble biomarkers of osteoarthritis: a method to analyze and interpret the results from an open-label trial in unilateral knee osteoarthritis patients. BMC Musculoskelet Disord. 2016 Oct 6;17(1):416.

Bay-Jensen AC, Thudium CS, Mobasheri A. Development and use of biochemical markers in osteoarthritis: current update. Curr Opin Rheumatol. 2018 Jan;30(1):121-128. doi: 10.1097/BOR.0000000000000467. Review.

Ding H, Wu T. Insulin-Like Growth Factor Binding Proteins in Autoimmune Diseases. Front Endocrinol (Lausanne). 2018 Aug 30;9:499. doi: 10.3389/fendo.2018.00499. eCollection 2018. Review.

• Responsible Party: Reham I El-mahdy, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03736109
• Other Study ID Numbers: Osteoarthritis
• First Posted: November 8, 2018
• Last Update Posted: January 10, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Reham I El-mahdy, Assiut University:

Copper-Albumin Complex; Osteoarthritis; Syndecan 4; Substance P; hyaluronic acid; Insulin like growth factor; Nitric oxide

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases