Effects of Oral Salmon Calcitonin in Human Osteoarthritis
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Osteoarthritis | Drug: oral salmon calcitonin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double 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
| Estimated Enrollment: | 54 |
| 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.
Eligibility
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| Ages Eligible for Study: | 50 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)
Contacts and Locations
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
| Belgium | |
| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00376311 History of Changes |
| Other Study ID Numbers: |
Daniel H Manicourt |
| First Submitted: | December 30, 2005 |
| First Posted: | September 14, 2006 |
| Last Update Posted: | September 14, 2006 |
| Last Verified: | June 2002 |
Keywords provided by Université Catholique de Louvain:
|
Lequesne's algo-functional score Biomarkers of joint metabolism |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Salmon calcitonin |
Calcitonin Calcitonin Gene-Related Peptide Bone Density Conservation Agents Physiological Effects of Drugs Vasodilator Agents |