Osteoarthritis (OA) Musculoskeletal Diseases Osteoarthritis
Conditions
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, u
Sponsors
Procter and Gamble Pharmaceuticals (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed