Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Tim Spector


Contact details

Consultant Rheumatologist
Professor of Genetic Epidemiology
Twin Research & Genetic Epidemiology Unit
St Thomas Hospital
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



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.

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

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Osteoarthritis (OA)


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.

Intervention type



Not Specified

Drug names


Primary outcome measure

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 measures

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.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Consultant Rheumatologist
United Kingdom

Sponsor information


Procter and Gamble Pharmaceuticals (USA)

Sponsor details

United States of America

Sponsor type




Funder type


Funder name

Procter and Gamble Pharmaceuticals (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Results in

Publication citations

  1. Results

    Spector TD, Conaghan PG, Buckland-Wright JC, Garnero P, Cline GA, Beary JF, Valent DJ, Meyer JM, Effect of risedronate on joint structure and symptoms of knee osteoarthritis: results of the BRISK randomized, controlled trial [ISRCTN01928173]., Arthritis Res. Ther., 2005, 7, 3, R625-33, doi: 10.1186/ar1716.

Additional files

Editorial Notes