Effects of Oral Salmon Calcitonin in Human Osteoarthritis
To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis|
- Lequesne's algofunctional index
- Biomarkers of joint metabolism
- Safety and tolerance
|Study Start Date:||September 2002|
|Estimated Study Completion Date:||May 2004|
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 (sCT) has positive effects in canine experimental OA, this phase IIa, randomized,placebo-controlled, double-blind trial evaluates the safety, tolerance and clinical efficacy of an oral formulation of sCT in patients with OA.
Patients receive a tablet containing either a placebo, 0.5 mg sCT or 1 mg sCT that they have to take every day in the morning 15 minutes before breakfast for 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376311
|St Luc University Hospital, Department of Rheumatology, Université Catholique de Louvain|
|Brussels, Belgium, B-1200|
|Study Director:||Daniel H Manicourt, MD, PhD||Department of Rheumatology, University hospital St Luc, Brussels, Belgium|