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11 February 2012
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| [ Print-friendly version ] |
| British study of Risedronate In Structure and symptoms of Knee osteoarthritis |
| ISRCTN | ISRCTN01928173 |
| ClinicalTrials.gov identifier | |
| Public title | British study of Risedronate In Structure and symptoms of Knee osteoarthritis |
| Scientific title | |
| Acronym | BRISK |
| Serial number at source | 2000024 |
| Study hypothesis | To determine the efficacy and safety of risedronate in patients with knee Osteoarthritis (OA). The British study of Risedronate In Structure and symptoms of Knee osteoarthritis (BRISK), a 1-year prospective, double-blind, placebo-controlled study enrolled patients (40 - 80 years) with mild-to-moderate medial compartment knee OA. The primary aims were to detect differences in symptoms and function. Patients were randomised to once-daily risedronate (5 mg or 15 mg) or placebo. |
| Lay summary | |
| Ethics approval | The subjects gave their written, informed consent before entering the study, which was conducted in accordance with the International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP) and was approved by the UK Multicentre Research Ethical Committee (MREC). |
| Study design | Prospective, double-blind, placebo-controlled study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Osteoarthritis (OA) |
| Participants - inclusion criteria |
1. Male and female subjects aged 40 - 80 years
2. Mild-to-moderate medial-compartment knee OA 3. Diagnosed according to the clinical and radiological criteria of the American College of Rheumatology 4. OA in at least one knee, designated as the signal knee, was required to meet the following clinical and radiographic criteria. Clinical inclusion criteria: 1. Presence of daily knee pain for at least 1 month out of 3 months prior to the study 2. At least one of the following: 2.1. Age greater than 50 years old 2.2. Morning knee stiffness of less than 30 minutes 2.3. Knee crepitus Radiographic criterion for inclusion: 1. A Joint-Space Width (JSW) of between 2 - 4 mm in the medial tibiofemoral compartment in the semi-flexed Anterior-Posterior (AP) view 2. A requirement for a narrower width than in the lateral compartment of the same knee 3. Patients were also required to have at least one osteophyte in either the medial or lateral compartments of the tibiofemoral joint |
| Participants - exclusion criteria |
1. The presence of rheumatic diseases that could be responsible for secondary OA
2. Use of intra-articular hyaluronic acid in the signal knee 3. Knee injury or diagnostic arthroscopy of the signal knee in the 6 months prior to enrolment 4. History of knee surgery (including arthroscopy requiring an incision of internal joint components) in the signal knee at any time 5. Intra-articular corticosteroids in the 3 months preceding enrolment 6. The presence of non-OA causes of knee pain in the signal knee (e.g. anserine bursitis, fibromyalgia and osteonecrosis) 7. Use of bisphosphonates within 12 months prior to enrolment |
| Anticipated start date | 01/01/2003 |
| Anticipated end date | 01/01/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 285 |
| Interventions |
Patients were randomised to:
1. 5 mg of Risedronate 2. 15 mg of Risedronate 3. Placebo Patients were treated once daily for one year. Knee radiographs were performed at baseline and at one year, urine and serum samples were collected at baseline and at months three, six and twelve and the Western Ontario and McMaster Universities OA Index was also performed. |
| Primary outcome measure(s) |
The outcome instrument for assessment of OA symptoms was evaluation of risedronate efficacy on symptoms of OA was the Western Ontario and McMaster Universities (WOMAC) OA index. The visual analogue scale (VAS) of the index was used, in which patients assessed each question using a 100 mm scale, with a higher score representing greater symptom severity. The total index score for the signal knee corresponded to the weighted composite of the 24 question scores standardised to a 100 point scale; scores were also determined for the subscales of pain (five questions), stiffness (two questions) and physical function (17 questions).
The outcome measure for assessment of joint structural changes was mean change from baseline in minimum JSW of the medial compartment of the knee. Radiographs of the knee were taken at baseline and at 1 year using a standardised radiographic method with fluoroscopic positioning of the joint in a semi-flexed position. |
| Secondary outcome measure(s) | Other symptom outcome measures included a Patient Global Assessment (PGA) of disease, consumption of pain medication and the use of walking aids. For the PGA, patients answered the following question using a VAS: Considering all the ways your OA affects you, how have you been in the last 48 hours? Results for the question were expressed as values on a 0 - 100 mm scale. |
| Sources of funding | Procter and Gamble Pharmaceuticals (USA) |
| Trial website | |
| Publications | Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15899049 |
| Contact name | Prof Tim Spector |
| Address |
Consultant Rheumatologist
Professor of Genetic Epidemiology Twin Research & Genetic Epidemiology Unit St Thomas Hospital |
| City/town | London |
| Zip/Postcode | SE1 7EH |
| Country | United Kingdom |
| Sponsor | Procter and Gamble Pharmaceuticals (USA) |
| Address | - |
| City/town | Mason, Ohio |
| Zip/Postcode | - |
| Country | United States of America |
| Sponsor website: | http://www.pgpharma.com/index.shtml |
| Date applied | 10/02/2005 |
| Last edited | 19/11/2007 |
| Date ISRCTN assigned | 14/02/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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