drugset / Trial / NCT04405960
Role of Alphacalcidol Supplement to Reduce Pain and COMP in Geriatric Knee Osteoarthritis Patients
RandomizedParallel-groupTriple-blindTreatment
Summary
Indonesian population's life expectancy has been increasing steadily in the last 3 decades. It potentially increases the prevalence of degenerative diseases, including osteoarthritis (OA). Serum Vitamin D (25(OH)D) level has been recognized as a risk factors for knee OA. Cartilage Oligomeric Matrix Protein (COMP) is cartilage degradation product can be used as a diagnostic marker for knee OA. This study aims to determine the effect of Vitamin D supplementation (Alphacalcidol) on pain based on WOMAC indicators and joint cartilage condition based on COMP serum markers in knee OA elderly patients.
Timeline
- Start
- 2017-07-01
- Primary completion
- 2017-09-30
- Completion
- 2017-12-31
Publications
- Background Gueli N, Verrusio W, Linguanti A, Di Maio F, Martinez A, Marigliano B, Cacciafesta M. Vitamin D: drug of the future. A new therapeutic approach. Arch Gerontol Geriatr. 2012 Jan-Feb;54(1):222-7. doi: 10.1016/j.archger.2011.03.001. Epub 2011 Apr 1.
- Background Bassiouni H, Aly H, Zaky K, Abaza N, Bardin T. Probing The Relation Between Vitamin D Deficiency and Progression of Medial Femoro-tibial Osteoarthitis of the Knee. Curr Rheumatol Rev. 2017;13(1):65-71. doi: 10.2174/1573397112666160404124532.
- Background Veronese N, Maggi S, Noale M, De Rui M, Bolzetta F, Zambon S, Corti MC, Sartori L, Musacchio E, Baggio G, Perissinotto E, Crepaldi G, Manzato E, Sergi G. Serum 25-Hydroxyvitamin D and Osteoarthritis in Older People: The Progetto Veneto Anziani Study. Rejuvenation Res. 2015 Dec;18(6):543-53. doi: 10.1089/rej.2015.1671. Epub 2015 Nov 5.
- Background Jansen JA, Haddad FS. High prevalence of vitamin D deficiency in elderly patients with advanced osteoarthritis scheduled for total knee replacement associated with poorer preoperative functional state. Ann R Coll Surg Engl. 2013 Nov;95(8):569-72. doi: 10.1308/rcsann.2013.95.8.569.
- Background Oemardi M, Horowitz M, Wishart JM, Morris HA, Need AG, O'loughlin PD, Nordin BE. The effect of menopause on bone mineral density and bone-related biochemical variables in Indonesian women. Clin Endocrinol (Oxf). 2007 Jul;67(1):93-100. doi: 10.1111/j.1365-2265.2007.02844.x. Epub 2007 May 9.
- Background Ebeling PR, Adler RA, Jones G, Liberman UA, Mazziotti G, Minisola S, Munns CF, Napoli N, Pittas AG, Giustina A, Bilezikian JP, Rizzoli R. MANAGEMENT OF ENDOCRINE DISEASE: Therapeutics of Vitamin D. Eur J Endocrinol. 2018 Oct 12;179(5):R239-R259. doi: 10.1530/EJE-18-0151.
- Background Palmer SC, McGregor DO, Craig JC, Elder G, Macaskill P, Strippoli GF. Vitamin D compounds for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD005633. doi: 10.1002/14651858.CD005633.pub2.
- Background Bartels EM, Christensen R, Christensen P, Henriksen M, Bennett A, Gudbergsen H, Boesen M, Bliddal H. Effect of a 16 weeks weight loss program on osteoarthritis biomarkers in obese patients with knee osteoarthritis: a prospective cohort study. Osteoarthritis Cartilage. 2014 Nov;22(11):1817-25. doi: 10.1016/j.joca.2014.07.027. Epub 2014 Aug 12.
- Background Verma P, Dalal K. Serum cartilage oligomeric matrix protein (COMP) in knee osteoarthritis: a novel diagnostic and prognostic biomarker. J Orthop Res. 2013 Jul;31(7):999-1006. doi: 10.1002/jor.22324. Epub 2013 Feb 19.
- Background Dirks NF, Ackermans MT, Lips P, de Jongh RT, Vervloet MG, de Jonge R, Heijboer AC. The When, What & How of Measuring Vitamin D Metabolism in Clinical Medicine. Nutrients. 2018 Apr 13;10(4):482. doi: 10.3390/nu10040482.
- Background Holick MF. Vitamin D status: measurement, interpretation, and clinical application. Ann Epidemiol. 2009 Feb;19(2):73-8. doi: 10.1016/j.annepidem.2007.12.001. Epub 2008 Mar 10.
- Background Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006 Mar;81(3):353-73. doi: 10.4065/81.3.353.
- Background Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29.
- Background KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
- Background Guermazi A, Hayashi D, Roemer F, Felson DT, Wang K, Lynch J, Amin S, Torner J, Lewis CE, Nevitt MC. Severe radiographic knee osteoarthritis--does Kellgren and Lawrence grade 4 represent end stage disease?--the MOST study. Osteoarthritis Cartilage. 2015 Sep;23(9):1499-505. doi: 10.1016/j.joca.2015.04.018. Epub 2015 Apr 28.
- Background Katz JN, Earp BE, Gomoll AH. Surgical management of osteoarthritis. Arthritis Care Res (Hoboken). 2010 Sep;62(9):1220-8. doi: 10.1002/acr.20231. No abstract available.
- Background Chapple CM, Nicholson H, Baxter GD, Abbott JH. Patient characteristics that predict progression of knee osteoarthritis: a systematic review of prognostic studies. Arthritis Care Res (Hoboken). 2011 Aug;63(8):1115-25. doi: 10.1002/acr.20492.
- Background Jin X, Jones G, Cicuttini F, Wluka A, Zhu Z, Han W, Antony B, Wang X, Winzenberg T, Blizzard L, Ding C. Effect of Vitamin D Supplementation on Tibial Cartilage Volume and Knee Pain Among Patients With Symptomatic Knee Osteoarthritis: A Randomized Clinical Trial. JAMA. 2016 Mar 8;315(10):1005-13. doi: 10.1001/jama.2016.1961.
- Background Ringe JD, Faber H, Fahramand P, Schacht E. Alfacalcidol versus plain vitamin D in the treatment of glucocorticoid/inflammation-induced osteoporosis. J Rheumatol Suppl. 2005 Sep;76:33-40.
- Background Schlogl M, Chocano-Bedoya P, Dawson-Hughes B, Orav EJ, Freystaetter G, Theiler R, Kressig RW, Egli A, Bischoff-Ferrari HA. Effect of Monthly Vitamin D on Chronic Pain Among Community-Dwelling Seniors: A Randomized, Double-Blind Controlled Trial. J Am Med Dir Assoc. 2019 Mar;20(3):356-361. doi: 10.1016/j.jamda.2018.09.004. Epub 2018 Nov 3.
- Background Muraki S, Dennison E, Jameson K, Boucher BJ, Akune T, Yoshimura N, Judge A, Arden NK, Javaid K, Cooper C. Association of vitamin D status with knee pain and radiographic knee osteoarthritis. Osteoarthritis Cartilage. 2011 Nov;19(11):1301-6. doi: 10.1016/j.joca.2011.07.017. Epub 2011 Aug 16.
- Background Bennell KL, Hunter DJ, Hinman RS. Management of osteoarthritis of the knee. BMJ. 2012 Jul 30;345:e4934. doi: 10.1136/bmj.e4934. No abstract available.
- Background Muraki S, Oka H, Akune T, Mabuchi A, En-yo Y, Yoshida M, Saika A, Suzuki T, Yoshida H, Ishibashi H, Yamamoto S, Nakamura K, Kawaguchi H, Yoshimura N. Prevalence of radiographic knee osteoarthritis and its association with knee pain in the elderly of Japanese population-based cohorts: the ROAD study. Osteoarthritis Cartilage. 2009 Sep;17(9):1137-43. doi: 10.1016/j.joca.2009.04.005. Epub 2009 Apr 17.
- Background Vanlint S. Vitamin D and obesity. Nutrients. 2013 Mar 20;5(3):949-56. doi: 10.3390/nu5030949.
- Background Salehpour A, Hosseinpanah F, Shidfar F, Vafa M, Razaghi M, Dehghani S, Hoshiarrad A, Gohari M. A 12-week double-blind randomized clinical trial of vitamin D(3) supplementation on body fat mass in healthy overweight and obese women. Nutr J. 2012 Sep 22;11:78. doi: 10.1186/1475-2891-11-78.
- Background Andersen RE, Crespo CJ, Ling SM, Bathon JM, Bartlett SJ. Prevalence of significant knee pain among older Americans: results from the Third National Health and Nutrition Examination Survey. J Am Geriatr Soc. 1999 Dec;47(12):1435-8. doi: 10.1111/j.1532-5415.1999.tb01563.x.
- Background Ding C, Cicuttini F, Parameswaran V, Burgess J, Quinn S, Jones G. Serum levels of vitamin D, sunlight exposure, and knee cartilage loss in older adults: the Tasmanian older adult cohort study. Arthritis Rheum. 2009 May;60(5):1381-9. doi: 10.1002/art.24486.
- Background Jungert A, Spinneker A, Nagel A, Neuhauser-Berthold M. Dietary intake and main food sources of vitamin D as a function of age, sex, vitamin D status, body composition, and income in an elderly German cohort. Food Nutr Res. 2014 Sep 17;58. doi: 10.3402/fnr.v58.23632. eCollection 2014.
- Background Sanghi D, Mishra A, Sharma AC, Singh A, Natu SM, Agarwal S, Srivastava RN. Does vitamin D improve osteoarthritis of the knee: a randomized controlled pilot trial. Clin Orthop Relat Res. 2013 Nov;471(11):3556-62. doi: 10.1007/s11999-013-3201-6. Epub 2013 Aug 1.
- Background Wu Z, Malihi Z, Stewart AW, Lawes CM, Scragg R. Effect of Vitamin D Supplementation on Pain: A Systematic Review and Meta-analysis. Pain Physician. 2016 Sep-Oct;19(7):415-27.
- Background Corvol MT, Dumontier MF, Tsagris L, Lang F, Bourguignon J. [Cartilage and vitamin D in vitro (author's transl)]. Ann Endocrinol (Paris). 1981 Oct-Nov;42(4-5):482-7. French.
- Background Wislowska M, Jablonska B. Serum cartilage oligomeric matrix protein (COMP) in rheumatoid arthritis and knee osteoarthritis. Clin Rheumatol. 2005 Jun;24(3):278-84. doi: 10.1007/s10067-004-1000-x. Epub 2004 Nov 18.
- Background Clark AG, Jordan JM, Vilim V, Renner JB, Dragomir AD, Luta G, Kraus VB. Serum cartilage oligomeric matrix protein reflects osteoarthritis presence and severity: the Johnston County Osteoarthritis Project. Arthritis Rheum. 1999 Nov;42(11):2356-64. doi: 10.1002/1529-0131(199911)42:113.0.CO;2-R.
- Background Andersson ML, Thorstensson CA, Roos EM, Petersson IF, Heinegard D, Saxne T. Serum levels of cartilage oligomeric matrix protein (COMP) increase temporarily after physical exercise in patients with knee osteoarthritis. BMC Musculoskelet Disord. 2006 Dec 7;7:98. doi: 10.1186/1471-2474-7-98.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alfacalcidol | Other / unclassified | 1 ug | Oral |