Status:
TERMINATED
Effects of Oral Salmon Calcitonin in Human Osteoarthritis
Lead Sponsor:
Université Catholique de Louvain
Collaborating Sponsors:
Novartis
Conditions:
Osteoarthritis
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief Summary
To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis
Detailed Description
Osteoarthritis (OA) is a difficult condition to manage and, thus far, we have no simple, effective interventions for this common cause of pain and disability. Because parenteral salmon calcitonin (sC...
Eligibility Criteria
Inclusion
- radiographic OA according to the criteria of the American College of Rheumatology;
- morning joint stiffness between 15 and 30 minutes;
- pain on weight bearing and motion reported greater than 40 mm on a 0-100 mm visual analogue scale;
- normal liver and kidney function tests;
- serum CRP levels \< 10 mg/l
Exclusion
- previous or ongoing treatment with anti-resorptive drugs such as bisphosphonates, estrogen or raloxifene
- crystal deposition diseases
- known hereditary or congenital defects
- clinically significant hepatic, renal, cardiovascular, psychiatric, endocrine and/or hematological diseases
- intra-articular injections of either corticosteroids (previous 3 months) or hyaluronan (previous 6 months)
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00376311
Start Date
September 1 2002
End Date
May 1 2004
Last Update
September 14 2006
Active Locations (1)
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1
St Luc University Hospital, Department of Rheumatology, Université Catholique de Louvain
Brussels, Belgium, B-1200