Effects of Oral Salmon Calcitonin in Human Osteoarthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00376311|
Recruitment Status : Terminated
First Posted : September 14, 2006
Last Update Posted : September 14, 2006
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Drug: oral salmon calcitonin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis|
|Study Start Date :||September 2002|
|Study Completion Date :||May 2004|
- Lequesne's algofunctional index
- Biomarkers of joint metabolism
- Safety and tolerance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|