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Basic & Clinical Research

A Study to Determine the Efficacy and Safety of Orally Administered 5 and 15mg/day, and 50mg/week Risedronate in Patients with Medial Compartment Knee Osteoarthritis in North America.

Objectives

To assess whether risedronate can slow the progression of joint space narrowing (JSN) (as measured radiographically in the medial compartment of the tibiofemoral joint) in the signal knee of patients with mild-to-moderate primary OA relative to placebo-treated patients.

To evaluate the effect of risedronate on pain, stiffness, functional status, patient's global assessment of his/her disease, osteophyte area on the medial and lateral tibial edges in the signal knee and use of pain medication for osteoarthritis.

Inclusion Criteria

Women or men, 40-80 years old

Normal TSH at screen, if on thyroid therapy

At least one knee with osteoarthritis, pain on most days during at least 1 month out of the past 3 months

At least one osteophyte

Must meet criteria as determined by central x-ray facility

Able to complete patient questionnaires

Exclusion Criteria

Conditions causing secondary knee OA

Untreated hyperparathyroidism

Untreated hyperthyroidism

Intra-articular injection of Corticosteroid into either knee within 3 months

Intra-articular injection of Hyaluronic Acid (Synvisc, Hyalagan) within 6 months

Knee surgery

Cancer within 10 years (except squamous or basal cell carcinoma, or cervical carcinoma in situ)

Non-OA causes of knee pain

Diagnostic arthroscopy without surgical procedure within 6 months

Injury to signal knee within 6 months requiring a MD visit

Major surgery requiring inpatient hospitalization within 1 month of screening

Treatment with tetracyclines within 6 months

Calcitonin or fluoride within 6 months

Use of bisphosphonates within 12 months

Corticosteroid use (>5mg/day Prednisone) within 3 months

CONTACT:
Denise Anzelmo, R.N.,CCRC
212-684-3315
Vivian Abellana, RN
(212) 598-6613
(212) 598-6650

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