British study of Risedronate In Structure and symptoms of Knee osteoarthritis

ISRCTN ISRCTN01928173
DOI https://doi.org/10.1186/ISRCTN01928173
Secondary identifying numbers 2000024
Submission date
10/02/2005
Registration date
14/02/2005
Last edited
19/11/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Tim Spector
Scientific

Consultant Rheumatologist
Professor of Genetic Epidemiology
Twin Research & Genetic Epidemiology Unit
St Thomas Hospital
London
SE1 7EH
United Kingdom

Study information

Study designProspective, double-blind, placebo-controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymBRISK
Study objectivesTo 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.
Ethics approval(s)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).
Health condition(s) or problem(s) studiedOsteoarthritis (OA)
InterventionPatients 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.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Risedronate
Primary outcome measureThe 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 measuresOther 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.
Overall study start date01/01/2003
Completion date01/01/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants285
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2003
Date of final enrolment01/01/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Consultant Rheumatologist
London
SE1 7EH
United Kingdom

Sponsor information

Procter and Gamble Pharmaceuticals (USA)
Industry

-
Mason, Ohio
-
United States of America

http://www.pgpharma.com/index.shtml
ROR logo https://ror.org/04dkns738

Funders

Funder type

Industry

Procter and Gamble Pharmaceuticals (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 24/03/2005 Yes No
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