- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00376311
Effects of Oral Salmon Calcitonin in Human Osteoarthritis
Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis
Study Overview
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 (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
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, B-1200
- St Luc University Hospital, Department of Rheumatology, Université Catholique de Louvain
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Lequesne's algofunctional index
|
Biomarkers of joint metabolism
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety and tolerance
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Daniel H Manicourt, MD, PhD, Department of Rheumatology, University hospital St Luc, Brussels, Belgium
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Daniel H Manicourt
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
-
Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
-
University Hospital, LilleCompleted
-
Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on oral salmon calcitonin
-
Nordic Bioscience A/SNovartisTerminatedOsteoarthritisUnited States, Spain, Denmark, Hong Kong, Poland, Romania, Czechia, Belgium, Canada, United Kingdom
-
NovartisCompletedPostmenopausal OsteoporosisDenmark
-
Nordic Bioscience A/SNovartisCompletedOsteoarthritisDenmark
-
NovartisCompletedPostmenopausal OsteoporosisDenmark
-
Nordic Bioscience A/SNovartisCompleted
-
Tarsa Therapeutics, Inc.CompletedOsteoporosisUnited States
-
Tarsa Therapeutics, Inc.CompletedOsteopeniaUnited States
-
Boston Children's HospitalNational Institutes of Health (NIH); Crohn's and Colitis FoundationCompletedCrohn's Disease | Ulcerative ColitisUnited States
-
Nordic Bioscience A/SNovartisCompletedOsteoarthritisDenmark, Estonia, Hong Kong, Poland, Romania, Czechia
-
University of Missouri-ColumbiaCompletedPelvic Ring FracturesUnited States