Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial
Objective: The osteoporosis drug strontium ranelate dissociates bone remodelling processes. It also inhibits subchondral bone resorption and stimulates cartilage matrix formation in vitro. Exploratory studies in the osteoporosis trialsreport that strontium ranelate reduces biomarkers of cartilage de...
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| Format: | Article |
| Language: | Russian |
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IMA PRESS LLC
2013-12-01
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| Series: | Научно-практическая ревматология |
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| Online Access: | https://rsp.mediar-press.net/rsp/article/view/1333 |
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| author | Cyrus Cooper J-Y Reginster R Chapurlat C Christiansen H Genant N Bellamy W Bensen F Navarro J Badurski E Nasonov X Chevalier P N Sambrook |
| author_facet | Cyrus Cooper J-Y Reginster R Chapurlat C Christiansen H Genant N Bellamy W Bensen F Navarro J Badurski E Nasonov X Chevalier P N Sambrook |
| author_sort | Cyrus Cooper |
| collection | DOAJ |
| description | Objective: The osteoporosis drug strontium ranelate dissociates bone remodelling processes. It also inhibits subchondral bone resorption and stimulates cartilage matrix formation in vitro. Exploratory studies in the osteoporosis trialsreport that strontium ranelate reduces biomarkers of cartilage degradation, and attenuates the progression and clinical symptoms of spinal osteoarthritis, suggesting symptom- and structure-modifying activity in osteoarthritis. We describethe rationale and design of a randomised trial evaluating the efficacy and safety of strontium ranelate in knee osteoarthritis.Research design, methods, and results: This double-blind, placebo-controlled trial (98 centres, 18 countries) includes ambulatory Caucasian men and women aged ≥50 years with primary knee osteoarthritis of the medial tibiofemoralcompartment (Kellgren and Lawrence grade 2 or 3), joint space width (JSW) 2.5 to 5 mm, and knee pain on most days in the previous month (intensity ≥40 mm on a visual analogue scale). Patients are randomly allocated to three groups (strontium ranelate 1 or 2g/day, or placebo). Follow-up is expected to last 3 years. The primary endpoint is radiographic change in JSW from baseline in each group versus placebo. The main clinical secondary endpoint is WOMAC score at the knee. Safety is assessed at every visit. It is estimated that 1600 patients are required to establish statistical significance with power >90% (0.2 mm ±10% between-group difference in change in JSW over 3 years). Recruitment started in April 2006. The results are expected in spring 2012.Clinical trial registration: The trial is registered on www.controlled-trials.com (number ISRCTN41323372).Conclusions: This randomised, double blind, placebo-controlled study will establish the potential of strontium ranelate in improving structure and symptoms in patients with knee osteoarthritis. |
| format | Article |
| id | doaj-art-5214a5955cbd4af085c0b1d0c2fade43 |
| institution | Kabale University |
| issn | 1995-4484 1995-4492 |
| language | Russian |
| publishDate | 2013-12-01 |
| publisher | IMA PRESS LLC |
| record_format | Article |
| series | Научно-практическая ревматология |
| spelling | doaj-art-5214a5955cbd4af085c0b1d0c2fade432025-08-20T03:38:12ZrusIMA PRESS LLCНаучно-практическая ревматология1995-44841995-44922013-12-0151548149410.14412/1995-4484-2013-15381273Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trialCyrus Cooper0J-Y Reginster1R Chapurlat2C Christiansen3H Genant4N Bellamy5W Bensen6F Navarro7J Badurski8E Nasonov9X Chevalier10P N Sambrook11MRC Lifecourse Epidemiology Unit, University of Southampton and NIHR Musculoskeletal Biomedical Research Unit, University of Oxford, UKDepartment of Public Health Epidemiology and Health Economics, University of Liege, Liege, BelgiumService de Rhumatologie et Pathologie Osseuse, Hopital Edouard Herriot, Lyon, FranceCCBR, Synarc, Ballerup, DenmarkMedicine, Epidemiology and Orthopaedic Surgery, University of California, San Francisco; and Synarc, San Francisco, CA, USACONROD, University of Queensland, Herston, Queensland, AustraliaMcMaster University Hamilton, Ontario, CanadaHospital Universitario Virgen Macarena, Sevilla, SpainCentre of Osteoporosis and Osteoarticular Diseases, Bialystok, PolandState Institute of Rheumatology, Russian Academy of Medical Sciences, Moscow, Russian FederationService de Rhumatologie, Hopital Henri Mondor, Creteil, FranceInstitute of Bone and Joint Research, Royal North Shore Hospital, St Leonards NSW, AustraliaObjective: The osteoporosis drug strontium ranelate dissociates bone remodelling processes. It also inhibits subchondral bone resorption and stimulates cartilage matrix formation in vitro. Exploratory studies in the osteoporosis trialsreport that strontium ranelate reduces biomarkers of cartilage degradation, and attenuates the progression and clinical symptoms of spinal osteoarthritis, suggesting symptom- and structure-modifying activity in osteoarthritis. We describethe rationale and design of a randomised trial evaluating the efficacy and safety of strontium ranelate in knee osteoarthritis.Research design, methods, and results: This double-blind, placebo-controlled trial (98 centres, 18 countries) includes ambulatory Caucasian men and women aged ≥50 years with primary knee osteoarthritis of the medial tibiofemoralcompartment (Kellgren and Lawrence grade 2 or 3), joint space width (JSW) 2.5 to 5 mm, and knee pain on most days in the previous month (intensity ≥40 mm on a visual analogue scale). Patients are randomly allocated to three groups (strontium ranelate 1 or 2g/day, or placebo). Follow-up is expected to last 3 years. The primary endpoint is radiographic change in JSW from baseline in each group versus placebo. The main clinical secondary endpoint is WOMAC score at the knee. Safety is assessed at every visit. It is estimated that 1600 patients are required to establish statistical significance with power >90% (0.2 mm ±10% between-group difference in change in JSW over 3 years). Recruitment started in April 2006. The results are expected in spring 2012.Clinical trial registration: The trial is registered on www.controlled-trials.com (number ISRCTN41323372).Conclusions: This randomised, double blind, placebo-controlled study will establish the potential of strontium ranelate in improving structure and symptoms in patients with knee osteoarthritis.https://rsp.mediar-press.net/rsp/article/view/1333базисные противовоспалительные препаратыширина суставной щелиостеоартроз коленного суставарентгенограмма коленарандомизированное клиническое исследованиестронция ранелатструктурно-модифицирующее лечение |
| spellingShingle | Cyrus Cooper J-Y Reginster R Chapurlat C Christiansen H Genant N Bellamy W Bensen F Navarro J Badurski E Nasonov X Chevalier P N Sambrook Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial Научно-практическая ревматология базисные противовоспалительные препараты ширина суставной щели остеоартроз коленного сустава рентгенограмма колена рандомизированное клиническое исследование стронция ранелат структурно-модифицирующее лечение |
| title | Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial |
| title_full | Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial |
| title_fullStr | Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial |
| title_full_unstemmed | Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial |
| title_short | Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial |
| title_sort | efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis rationale and design of randomised double blind placebo controlled trial |
| topic | базисные противовоспалительные препараты ширина суставной щели остеоартроз коленного сустава рентгенограмма колена рандомизированное клиническое исследование стронция ранелат структурно-модифицирующее лечение |
| url | https://rsp.mediar-press.net/rsp/article/view/1333 |
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